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Trial registered on ANZCTR
Registration number
ACTRN12625000042448
Ethics application status
Approved
Date submitted
26/11/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effect of high-intensity functional training combined with selenium and zinc co-supplementation on sleep quality, functional capacity and weight loss in overweight and obese people
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Scientific title
Effect of high-intensity functional training combined with selenium and zinc co-supplementation on sleep quality, functional capacity and weight loss in overweight and obese people: a randomized double-blind and placebo-controlled trial
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Secondary ID [1]
313443
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Overweight
335827
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Obesity
335828
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Condition category
Condition code
Metabolic and Endocrine
332400
332400
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0
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Thyroid disease
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Metabolic and Endocrine
332401
332401
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0
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Metabolic disorders
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Physical Medicine / Rehabilitation
332402
332402
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0
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Other physical medicine / rehabilitation
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Musculoskeletal
332403
332403
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0
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Normal musculoskeletal and cartilage development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants were randomly divided into two groups. Both groups underwent a 6-week intervention that included a hypocaloric diet and a high-intensity functional training program (HIFT). They differed based on whether they concurrently received one zinc and one selenium supplement or two placebos. The participants in the zinc-selenium co-supplementation group received a supplement containing 25 mg of zinc gluconate and another supplement containing 200 mcg of Se L-selenomethionine.
After the baseline measurements, all participants were contacted by the research team's clinical dietician to create a custom-made diet plan. During the interview, participants provided information about their food preferences, allergies, and intolerances. A 24-hour dietary recall was used, with participants reporting their food and beverage intake in the 24-hour period before the interview. The diet plan covered the recommended dietary allowances, and the macronutrients distribution was 50% carbohydrates, 30% protein, and 20% fat. The total calories given to every participant were calculated considering the resting metabolic rate and the caloric expenditure of exercise and physical activity minus 500 calories to follow a hypocaloric diet.
The participants of both groups participated in a group-based circuit-type HIFT two times/week and for six weeks. All classes were supervised by an experienced exercise scientist, and the number of participants in each class was small (8 people). Upon arrival at the gym’s facilities, participants performed a ten-minute warm-up using the three-phase RAMP method (Raise, Activate-Mobilize, Potentiate). Following the warm-up, participants completed the main protocol, which included 8-10 cardiometabolic, multi-joint resistance (upper-body; push and pull, lower-body knee-dominant; squat and lunge, hip-dominant; hinge and bridge, and core; plank movements) and neuromotor exercises (exercises aimed to improve balance, agility, coordination, reaction time, and proprioception), for 1-3 rounds. The appropriate exercise technique and baseline starting exercises for each participant were determined in a training session before the start of the intervention. At the end of every round, a rate of perceived exertion (RPE) measurement was conducted using the Borg RPE scale 6-20 to assess the level of exertion participants felt during the HIFT sessions. The mean RPE of each training day was also calculated. Furthermore, mean and maximum heart rates were monitored using Polar heart rate monitors (Polar® H7, Polar Electro Oy®, Kempele, Finland) for one session to measure exercise intensity objectively. The mean heart rate reverse of the participants was maintained higher 60% throughout each session. Progressive overload was achieved by decreasing the rest intervals or increasing the work intervals weekly and by increasing the number of exercises. When any of the exercises started to feel easier, the participants progressed to a harder variation. A 5-minute cool-down, including walking and static stretching exercises, was conducted at the end of the main training.
The participants' adherence to the supplements was calculated using the number of remaining tablets at the end of the intervention. Adherence to the exercise program was determined by calculating the number of training days lost using a session attendance sheet. The data were analyzed only if compliance with the exercise program and supplement consumption was equal to or higher than 90%.
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Intervention code [1]
330015
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Treatment: Other
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Comparator / control treatment
The control group participants received two pills of identical color and shape to the zinc-selenium co-supplementation group containing starch.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Anthropometry
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Assessment method [1]
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Body mass was measured using a calibrated scale (Sega, Germany) with minimum clothes and without shoes. Height was measured without shoes by a wall-mounted stadiometer with a precision of 0.5 cm. Body mass index (BMI) was calculated using the formula weight (kg)/ height2 (m2). Body mass, body fat, and muscle mass were meas-ured using multi-frequency bioimpedance technology (Tanita, MC980Uplus, Tan-ita Corp., Tokyo, Japan).
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Timepoint [1]
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Baseline and after the 6-week intervention period.
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Primary outcome [2]
339961
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Thyroid function was determined by measuring thyroid-stimulated hormone, free thyroxine, and free triiodothyronine blood levels
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Assessment method [2]
339961
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FT3 was measured by chemiluminescent microparticle immunoassay using Abott Architect 2000 analyzer. FT4 and TSH were measured by electrochemiluminescence immunoassay in the Elecsys 2010 immunoassay system. ‘This will be assessed as a composite outcome’.
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Timepoint [2]
339961
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Baseline and after the 6-week intervention period.
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Primary outcome [3]
339962
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Zinc serum levels
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Assessment method [3]
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Zinc was assessed using the Abbot Architect 2000 immunoassay analyzer.
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Timepoint [3]
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Baseline and after the 6-week intervention period.
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Secondary outcome [1]
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"This was an additional priamary outcome". Resting Metabolic Rate .
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Assessment method [1]
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RMR was estimated using indirect calorimetry (Quark CPET, Cosmed, Rome, Italy). The tests were conducted early in the morning. Initially, the participants laid on a reclined bed for 15 minutes in a dark, quiet room. Then, the respiratory face mask was placed, and RMR was measured for 15 minutes. Participants were asked to abstain from strenuous exercise and from eating for at least 48 hours and 12 hours before the measurement, respectively. The metabolic cart was switched on 30 minutes before the measurement and was calibrated before each measurement. In addition to RMR, the percentage of fat and carbohydrate oxidation was collected by the end of the test.
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Timepoint [1]
442091
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Baseline and after the 6-week intervention period.
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Secondary outcome [2]
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Functional Capacity
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Assessment method [2]
442092
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Functional capacity was assessed by a series of functional tests, including Sit to Stand 5 (STS-5), Sit to Stand 60 (STS-60), and the "Timed Up and Go Test". The STS-5 requires the participants to perform five sit-to-stand cycles as fast as possible, and it can be used to indicate the strength of the lower extremities. The STS-60 requires the assessee to stand up and sit on a chair as many times as possible in 60 seconds. The score is the total number of sit-to-stand cycles within 30 and 60 seconds, and it is an index of muscular endurance. The Timed Up and Go test evaluates agility, dynamic balance, and functional mobility and requires patients to stand up out of a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Handgrip strength was assessed using a digital hand-held dynamometer (T.K.K. 5401 Grip - D; Takey, Japan). For this test, the assessee stands with hands in the neutral position by the side of the body. Then, participants were asked to hold and squeeze the dynamometer for 3 seconds with the elbow flexed at 90 degrees. No other body movement was allowed. The measurement was performed by both the right and left arms. ‘This will be assessed as a composite outcome’
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Timepoint [2]
442092
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Baseline and after the 6-week intervention period.
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Secondary outcome [3]
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Maximal oxygen uptake
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Assessment method [3]
442093
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Maximal oxygen uptake (VO2max) was determined using an incremental cycling test on a cycle ergometer (LC6, Monark, Sweden) using a breath-by-breath gas analysis (Quark CPET, Cosmed, Rome, Italy). The initial workload of the incremental was set at 50 W and was increased by 25 W every minute until the participants reached volitional exhaustion or could not maintain a cadence of 60 rpm and the respiratory exchange ratio was above 1.1. Heart rate was continuously monitored with a Polar heart rate monitor (Polar® H7, Polar Electro Oy®, Kempele, Finland). The tests were performed by an exercise physiologist - research team member
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Timepoint [3]
442093
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Baseline and after the 6-week intervention period.
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Secondary outcome [4]
442094
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Sleep quality
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Assessment method [4]
442094
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The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality. PSQI is a questionnaire with good validity and high reliability on a various population groups.
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Timepoint [4]
442094
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Baseline and after the 6-week intervention period
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Secondary outcome [5]
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Quality of Life
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Assessment method [5]
442095
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The 36-Item Short Form Health Survey SF-36 questionnaire, which has acceptable validity, reliability, and sensitivity, was used to examine quality of life of the participants.
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Timepoint [5]
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Baseline and after the 6-week intervention period. .
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Secondary outcome [6]
443170
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"This is an additional primary outcome". Body Composition.
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Assessment method [6]
443170
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Bioelectrical impedance analysis (BIA).
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Timepoint [6]
443170
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Baseline and after the 6-week intervention period.
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Secondary outcome [7]
443171
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"This is an additional primary outcome". Selenium serum levels.
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Assessment method [7]
443171
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Selenium was assessed by graphite furnace atomic absorption spectroscope using Perkin Elmer PinAAcle 900.
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Timepoint [7]
443171
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Baseline and at the end of the 6-week intervention period
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Eligibility
Key inclusion criteria
Inclusion criteria for the study were: (a) overweight or obese men and women (BMI > 25); (b) age 18–40 years; (c) no diet intervention during at least the last three months; and (d) no use of nutritional supplements/medications before (3 months) and during the study.
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria were: (a) history of thyroid disease, positivity for thyroid autoanti-bodies, or treatment with medications potentially interfering with thyroid function; (b) diagnosis of cardiovascular, metabolic, pulmonary, renal, musculoskeletal, or mental disorders; and (c) pregnancy or lactation.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered, opaque, sealed
envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We generated the two comparison groups using simple
randomization, with an equal allocation ratio, by referring to a table of random numbers.
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
13/10/2023
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Date of last participant enrolment
Anticipated
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Actual
15/11/2023
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Date of last data collection
Anticipated
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Actual
26/01/2024
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Sample size
Target
16
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Accrual to date
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Final
16
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Recruitment outside Australia
Country [1]
26753
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Cyprus
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State/province [1]
26753
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Funding & Sponsors
Funding source category [1]
317882
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Self funded/Unfunded
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Name [1]
317882
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Antonis Zavros
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Address [1]
317882
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Country [1]
317882
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Cyprus
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Primary sponsor type
Individual
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Name
Christoforos Giannaki, University of Nicosia, Nicosia, Cyprus
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Address
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Country
Cyprus
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Secondary sponsor category [1]
320219
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None
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Name [1]
320219
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Address [1]
320219
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Country [1]
320219
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316567
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Cyprus National Bioethics Committee
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Ethics committee address [1]
316567
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22 Laertou Str., Ayios Dometios, Nicosia, CY-2365, Cyprus
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Ethics committee country [1]
316567
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Cyprus
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Date submitted for ethics approval [1]
316567
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10/04/2020
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Approval date [1]
316567
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28/05/2020
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Ethics approval number [1]
316567
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Summary
Brief summary
Zinc (Zn) and selenium (Se) are trace elements that contribute to important biological processes in the human body. Cumulating research has demonstrated that obese people have lower Zn plasma levels compared with normal-weight people and that Se and Zn circulatory levels are inversely correlated with obesity and body fat mass. However, the evidence regarding the effects of the two micronutrients on body composition is conflicting. Furthermore, overweight and obese individuals are frequently characterized by reduced physical performance and disrupted thyroid function. This randomized double-blind and placebo-controlled trial examined the effects of Zn and Se co-supplementation on thyroid function, Zn and Se blood levels, resting metabolic rate, exercise performance, body composition, sleep quality, and quality of life in overweight and obese people undergoing diet and high-intensity functional training. Considering previous research indicating significant reductions in body weight and fat following a period of hypocaloric dieting combined with a HIFT program, we hypothesized that including Zn and Se supplements in this intervention would lead to even greater decreases in these parameters, and that would further improve functional capacity, resting metabolic rate, and sleep quality measures.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Antonis Zavros
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Address
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University of Nicosia, 46 Makedonitissas Avenue, Nicosia, CY-2417
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Country
138270
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Cyprus
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Phone
138270
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+35799831207
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Fax
138270
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Email
138270
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[email protected]
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Contact person for public queries
Name
138271
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Antonis Zavros
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Address
138271
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University of Nicosia, 46 Makedonitissas Avenue, Nicosia, CY-2417
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Country
138271
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Cyprus
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Phone
138271
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+35799831207
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Fax
138271
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Email
138271
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[email protected]
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Contact person for scientific queries
Name
138272
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Antonis Zavros
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Address
138272
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University of Nicosia, 46 Makedonitissas Avenue, Nicosia, CY-2417
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Country
138272
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Cyprus
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Phone
138272
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+35799831207
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Fax
138272
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Email
138272
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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