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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
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
Secondary ID [1] 313443 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 335827 0
Obesity 335828 0
Condition category
Condition code
Metabolic and Endocrine 332400 332400 0 0
Thyroid disease
Metabolic and Endocrine 332401 332401 0 0
Metabolic disorders
Physical Medicine / Rehabilitation 332402 332402 0 0
Other physical medicine / rehabilitation
Musculoskeletal 332403 332403 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
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%.

Intervention code [1] 330015 0
Treatment: Other
Comparator / control treatment
The control group participants received two pills of identical color and shape to the zinc-selenium co-supplementation group containing starch.
Control group
Placebo

Outcomes
Primary outcome [1] 339960 0
Anthropometry
Timepoint [1] 339960 0
Baseline and after the 6-week intervention period.
Primary outcome [2] 339961 0
Thyroid function was determined by measuring thyroid-stimulated hormone, free thyroxine, and free triiodothyronine blood levels
Timepoint [2] 339961 0
Baseline and after the 6-week intervention period.
Primary outcome [3] 339962 0
Zinc serum levels
Timepoint [3] 339962 0
Baseline and after the 6-week intervention period.
Secondary outcome [1] 442091 0
"This was an additional priamary outcome". Resting Metabolic Rate .
Timepoint [1] 442091 0
Baseline and after the 6-week intervention period.
Secondary outcome [2] 442092 0
Functional Capacity
Timepoint [2] 442092 0
Baseline and after the 6-week intervention period.
Secondary outcome [3] 442093 0
Maximal oxygen uptake
Timepoint [3] 442093 0
Baseline and after the 6-week intervention period.
Secondary outcome [4] 442094 0
Sleep quality
Timepoint [4] 442094 0
Baseline and after the 6-week intervention period
Secondary outcome [5] 442095 0
Quality of Life
Timepoint [5] 442095 0
Baseline and after the 6-week intervention period.
.
Secondary outcome [6] 443170 0
"This is an additional primary outcome". Body Composition.
Timepoint [6] 443170 0
Baseline and after the 6-week intervention period.
Secondary outcome [7] 443171 0
"This is an additional primary outcome". Selenium serum levels.
Timepoint [7] 443171 0
Baseline and at the end of the 6-week intervention period

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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered, opaque, sealed
envelopes.
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.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/10/2023
Date of last participant enrolment
Anticipated
Actual
15/11/2023
Date of last data collection
Anticipated
Actual
26/01/2024
Sample size
Target
16
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 26753 0
Cyprus
State/province [1] 26753 0

Funding & Sponsors
Funding source category [1] 317882 0
Self funded/Unfunded
Name [1] 317882 0
Antonis Zavros
Country [1] 317882 0
Cyprus
Primary sponsor type
Individual
Name
Christoforos Giannaki, University of Nicosia, Nicosia, Cyprus
Address
Country
Cyprus
Secondary sponsor category [1] 320219 0
None
Name [1] 320219 0
Address [1] 320219 0
Country [1] 320219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316567 0
Cyprus National Bioethics Committee
Ethics committee address [1] 316567 0
Ethics committee country [1] 316567 0
Cyprus
Date submitted for ethics approval [1] 316567 0
10/04/2020
Approval date [1] 316567 0
28/05/2020
Ethics approval number [1] 316567 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138270 0
Dr Antonis Zavros
Address 138270 0
University of Nicosia, 46 Makedonitissas Avenue, Nicosia, CY-2417
Country 138270 0
Cyprus
Phone 138270 0
+35799831207
Fax 138270 0
Email 138270 0
zavrosantonis@gmail.com
Contact person for public queries
Name 138271 0
Antonis Zavros
Address 138271 0
University of Nicosia, 46 Makedonitissas Avenue, Nicosia, CY-2417
Country 138271 0
Cyprus
Phone 138271 0
+35799831207
Fax 138271 0
Email 138271 0
zavrosantonis@gmail.com
Contact person for scientific queries
Name 138272 0
Antonis Zavros
Address 138272 0
University of Nicosia, 46 Makedonitissas Avenue, Nicosia, CY-2417
Country 138272 0
Cyprus
Phone 138272 0
+35799831207
Fax 138272 0
Email 138272 0
zavrosantonis@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.