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Trial registered on ANZCTR


Registration number
ACTRN12619000595112
Ethics application status
Approved
Date submitted
5/02/2019
Date registered
17/04/2019
Date last updated
2/08/2022
Date data sharing statement initially provided
17/04/2019
Date results provided
2/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the weight management effect of a new Probiotic Super Green Powder supplement in healthy overweight people
Scientific title
Investigate the weight management effect of Probiotic Super Green Powder (a dietary supplement containing white kidney bean extract, blood orange extract, dietary fibre, and probiotics) in healthy overweight participants
Secondary ID [1] 297305 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 311395 0
Obesity 311396 0
Condition category
Condition code
Alternative and Complementary Medicine 310028 310028 0 0
Other alternative and complementary medicine
Diet and Nutrition 310029 310029 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each 16g sachet of Probiotic Super Green Powder is made from the following ingredients: Non-dairy Creamer (4.0g; 24.92%), Psyllium Seed Husk Powder (3.5g; 21.81%), Banana Powder (3.5 g; 21.81%), Xylitol (3.5g; 21.81%), PHASE 2 White Kidney Bean Extract (1.0g; 6.23%), Probiotics (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum) (0.3g; 1.87%), Green Tea Powder (0.15g; 0.93%), MOROSIL Blood Orange Powder (0.1g; 0.62%).

Probiotic Super Green Powder (16g per sachet; n = 30) or a placebo without any active constituents (16g per sachet; n = 30) for a period of 8 weeks. Both supplements will be packaged in identically and provided in the form of powered matched for colour and taste. Participants will be instructed to ingest one sachet (16g) three times a day (sprinkled over breakfast/lunch/dinner or dissolved in water before each meal) as per manufacture recommendations.

As the supplementation protocol involved taking 3 sachets daily for 8 weeks, the total dose of probiotics in this intervention is 50.4g (0.9g per day), made of the constitutes described above.

Individuals expressing interest in participating in this study will be initially interviewed on the phone or in person to determine suitability to participate in this study. Participants believed to meet eligibility criteria will be invited to attend a familiarization session.

Participants will be familiarized with the study purpose, design, and the risks and benefits associated with their participation in this study. They will then read and sign the Informed Consent document (if agreeing to participate) and complete personal history and medical history questionnaires. Participants will then have their body mass and height measured to ensure that they meet the BMI requirements. Participants will be asked then be asked to ingest the supplement (Probiotic Super Green Powder) and sit for approximately 30 minutes to ensure no adverse reactions from the active ingredient.

After this, the initial testing session (T1) will begin, with participants completing questionnaires about food cravings, eating behaviours, and attitudes and satiety using a Food Craving Inventory and Food Frequency Questionnaire (includes snacking frequency). Mood status will be assessed via the Profile of Mood States (POMS) questionnaire. A side effects questionnaire will also be administered. Participants will have their blood pressure will be measured using a sphygmomanometer, body composition measured using bioelectrical impedance analysis, and waist circumference measured using a tape measure. Participants will then donate a venous blood sample. Blood samples will be drawn in the morning after an overnight fast using standard phlebotomy techniques. Stool samples will be collected by participants using a stool collection kit.

At the end of T1, participants will be randomly placed into the supplement or placebo group and matched according to their BMI, body composition and reported snacking frequency. Participants will be asked to not alter their diet or exercise habits throughout the duration of the study.

Participants will receive weekly support-orientated phone calls to ensure that procedures are being followed and how they are tolerating the supplement. During the supplementation period, participants will complete a food and physical activity diary. At the end of 8 weeks of supplementation, participants will be asked to cease taking the supplement and undertake subsequent testing (T2). This will include the same anthropometric, questionnaire and blood sampling procedures undertaking in T1. To monitor compliance, participants will be given a supplement checklist which they can use to mark when they have taken to supplements. They will be asked to return this checklist and any additional supplements to the researchers at the T2 visit.

Participants will then be asked to maintain a similar diet and exercise regime for another 4 weeks and to then return to the laboratory for follow up testing (T3).

Following the completion of all testing, participants in the placebo group will be given the opportunity to receive 8-weeks’ worth of Probiotic Super Green Powder if it is found to be effective.
Intervention code [1] 313557 0
Treatment: Other
Comparator / control treatment
A flavour matched placebo (non-dairy creamer and xylitol based) without any active constituents.
Control group
Placebo

Outcomes
Primary outcome [1] 318929 0
Body Composition (Bioelectrical Impedance Analysis - Composite Primary Outcome): Body composition (fat mass, muscle mass and total body water) will be measured using Bioelectrical Impedance Analysis (BIA, Tanita Scales) which measures bio-resistance of water and body tissue based on a minute low energy, high frequency current (500 micro-amps at a frequency of 50 kHz) transmitted through the body. This analyzer is commercially available and has been used in the health care/fitness industry to assess body composition for over 20 years.
Timepoint [1] 318929 0
Baseline (week 0 / T1), post intervention (week 8 /T2), four week follow up post intervention (week 12 /T3).
Primary outcome [2] 318930 0
Food Frequency: A validated online 120-item semi-quantitative food frequency questionnaire (Australian Eating Survey) (O’Brien et al. 2014) will be administered. Participants will self-report frequency of food consumption for the previous 8 weeks at T1 and T2.
Timepoint [2] 318930 0
Baseline (week 0 / T1) and post intervention (week 8 /T2).
Primary outcome [3] 319032 0
Food Craving:: The Food Craving Inventory will be used to provide a reliable and valid assessment of cravings for different types of food and will be administered at each testing session. This tool defines cravings as “an intense desire to consume a particular food that is difficult to resist” and contains 37 food. Participants will rate how often they experienced a craving of each of the foods over the past month using a 5-point Likert scale. Validation of this tool demonstrates four conceptual subscales that comprise of the highest-order construct of “food craving” (White et al. 2002).
Timepoint [3] 319032 0
Baseline (week 0 / T1), post intervention (week 8 /T2), four week follow up post intervention (week 12 /T3).
Secondary outcome [1] 366461 0
3 day food intake and activity: To monitor dietary intake and exercise activity during the study, participants will be required to keep three-day dietary and physical activity records (2 weekdays and 1 weekend day) prior to each testing session through the duration of the study. These records will be evaluated using the Foodworks dietary assessment software program (FoodWorks, Xyris Software). This is a composite secondary outcome.
Timepoint [1] 366461 0
Baseline (week 0 / T1), post intervention (week 8 /T2), four week follow up post intervention (week 12 /T3).
Secondary outcome [2] 366462 0
Side effects from supplementation: To determine whether the participants suffered any side effects from the placebo or supplement, participants will report by questionnaire administered in a confidential manner whether they tolerated the supplement, supplementation protocol, as well as any medical problems/symptoms they may have encountered throughout the study. There are no known side effects on this supplement, thus we will asking participants to report on general and potential gastrointestinal side effects (bloating, diarrhoea, constipation, nausea, vomiting) or "other" which will be at the participants discretion.
Timepoint [2] 366462 0
Baseline (week 0 / T1) and post intervention (week 8 /T2) at clinical trials, and over the phone throughout the intervention.
Secondary outcome [3] 366758 0
Mood State: Participants will complete a Profile of Mood State (POMS) questionnaire (Multi-Health System Inc.) at each testing session to determine the effects of the supplement and the intervention on their mood.
Timepoint [3] 366758 0
Baseline (week 0 / T1), post intervention (week 8 /T2), four week follow up post intervention (week 12 /T3).
Secondary outcome [4] 366761 0
Blood pressure: Blood pressure will be assessed in the supine position after resting for 5-mins using a mercurial sphygmomanometer using standard procedures.
Timepoint [4] 366761 0
Baseline (week 0 / T1), post intervention (week 8 /T2), four week follow up post intervention (week 12 /T3).
Secondary outcome [5] 366763 0
Blood biochemistry: lood samples (15 ml) will be drawn using standard sterile venepuncture techniques by a trained phlebotomist. All samples will be obtained from a vein in the antecubital fossa of the arm using standard phlebotomy procedures. Personal protective equipment (i.e. gloves, lab coat, googles) will be worn when handling blood samples. For sample collection, participants will rest in a supine position. Their arm will be cleaned with a sterile alcohol wipe. A standard tourniquet will be placed on the upper arm and tightened enough to visibly indent the skin, but not cause the participant discomfort. An acceptable vein will then be palpated and a 22 gauge sterile needle attached to a plastic plasma separating vacutainer holder will be inserted into the vein using standard procedures. A serum separating vacutainer tube will subsequently be inserted into the holder using multiple sample phlebotomy techniques. Once samples are obtained, the vacutainer holder and needle will be removed and discarded as hazardous waste in a plastics sharps container. A gauze swap will be placed at the site of the of the blood draw and adequate pressure applied till the site is clotted.

Serum samples will be decanted and aliquoted into name de-identifiable labelled tubes, snap frozen in liquid nitrogen, and stored in a -80°C freezer for subsequent analysis. Serum samples will be assayed in the RMIT Biosciences Laboratory for a standard clinical chemistry profile (including glucose, triglycerides, cholesterol). This is a composite outcome.
Timepoint [5] 366763 0
Baseline (week 0 / T1), post intervention (week 8 /T2), four week follow up post intervention (week 12 /T3).
Secondary outcome [6] 366764 0
Stool Samples / gut microbiome testing: Briefly, stool samples will be collected by participants using a collection kit that includes a toilet hat, instructions for collecting/mailing the specimen, a collection tube, exam gloves, alcohol wipes, a postage-paid return mailing envelope, and biohazard mailing bag. Participants will be recommended to mail their samples to researchers immediately post collection. These samples will be used for microbiome analysis using qPCR.
Timepoint [6] 366764 0
Baseline (week 0 / T1), post intervention (week 8 /T2), four week follow up post intervention (week 12 /T3).

Eligibility
Key inclusion criteria
Overweight (body mass index greater than 25 kg/m2) males and females aged between 18 - 55 years who are deemed eligible to participate as indicated by not meeting one or more of the exclusion criterion (listed below)
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from participating within the project for the following reasons: Individuals with presence of psychiatric disorders, pathologic eating disorders, chronic diseases related to the metabolism of energy and nutrients (i.e. hyperthyroidism), and/or unable or unwilling to give informed consent. These exclusion criterion are set as they may influence an individual’s ability to comply with the recommendations of the nutritional intervention.
Additional exclusion criterion include: weight instable in the previous 3 months (evident by a loss or gain of more than 10% of total body weight), pregnant, post-menopausal, taking contraindicated mediation (e.g. antibiotics, psychotrophic drugs or appetite suppressants) or the use of any dietary supplement that might interfere with the results of the study. These additional exclusion criterion are set as the may exert an independent influence on anthropometric, biochemical, clinical and/or dietary outcomes monitored throughout the intervention.

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)
Treatment is double blinded. Supplements have been labelled A and B. An individual not involved in undertaking the study holds the code, which will be revealed following statistical analysis of the data. Supplements are wrapped in plain silver packaging and provided in a larger box labelled either A or B.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation is randomised by coin toss (heads, A; tails, B).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical power for a sample size of two groups of 40 participants was calculated upon previously published data (Cardile et al. 2015). Body weight, BMI, waist and hip circumference in overweight healthy human volunteers were significantly different (p < 0.05) from the placebo group in response to a 12-week nutritional intervention, using a cohort of n=30 per group (Cardile et al. 2015). This is considered acceptable as the level of probability for the current project will be set at p < 0.05. Based on allowances for attrition, including predicted dropout rates, sample size per group was inflated by 25% for the current project (to n=40 per group).

Univariate data will be analysed using SPSS for Windows Version 24 software. Differences between the treatment / control groups and anthropometric, biochemical, clinical and dietary measurements will be examined using unpaired repeated-measures two-way ANOVA’s. Where univariate analysis reveal any significant main effects for time, subsequent pairwise comparisons will be performed to detect differences over time. Where a group by time interaction is detected, multiple comparisons with Tukey’s post hoc tests will be completed to identify differences. One-way ANOVA’s will be performed on participant characteristic data, with unpaired t-tests completed if interactions between factors are found. Data will be expressed as mean ± SEM unless otherwise stated. The level of probability will be set at p < 0.05.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Ceased due to COVID19 related University close down.
Date of first participant enrolment
Anticipated
Actual
4/03/2019
Date of last participant enrolment
Anticipated
18/08/2019
Actual
23/03/2020
Date of last data collection
Anticipated
Actual
23/03/2020
Sample size
Target
80
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 25554 0
3083 - Bundoora
Recruitment postcode(s) [2] 25555 0
3000 - Melbourne
Recruitment postcode(s) [3] 25556 0
3001 - Melbourne

Funding & Sponsors
Funding source category [1] 301866 0
Commercial sector/Industry
Name [1] 301866 0
Bio-E Australia Pty Ltd.
Country [1] 301866 0
Australia
Funding source category [2] 301867 0
Government body
Name [2] 301867 0
Victorian Department of Economic Development, Jobs, Transport and Resources
Country [2] 301867 0
Australia
Primary sponsor type
University
Name
RMIT Univerisity
Address
124 La Trobe St, Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 301617 0
None
Name [1] 301617 0
Address [1] 301617 0
Country [1] 301617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302560 0
RMIT University Human Research Ethics Committee
Ethics committee address [1] 302560 0
Ethics committee country [1] 302560 0
Australia
Date submitted for ethics approval [1] 302560 0
20/06/2018
Approval date [1] 302560 0
01/10/2018
Ethics approval number [1] 302560 0
21533

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

Contacts
Principal investigator
Name 90654 0
Dr Jessica Danaher
Address 90654 0
Royal Melbourne Institute of Technology (RMIT) University
124 La Trobe St, Melbourne VIC 3000
Country 90654 0
Australia
Phone 90654 0
+61 03 9925 6117
Fax 90654 0
Email 90654 0
jessica.danaher@rmit.edu.au
Contact person for public queries
Name 90655 0
Jessica Danaher
Address 90655 0
Royal Melbourne Institute of Technology (RMIT) University
124 La Trobe St, Melbourne VIC 3000
Country 90655 0
Australia
Phone 90655 0
+61 03 9925 6117
Fax 90655 0
Email 90655 0
jessica.danaher@rmit.edu.au
Contact person for scientific queries
Name 90656 0
Jessica Danaher
Address 90656 0
Royal Melbourne Institute of Technology (RMIT) University
124 La Trobe St, Melbourne VIC 3000
Country 90656 0
Australia
Phone 90656 0
+61 03 9925 6117
Fax 90656 0
Email 90656 0
jessica.danaher@rmit.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data will be coded and combined in a larger data set. Results presented to the public will be representative of the mean result of the larger data set.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1301Informed consent form    376899-(Uploaded-05-02-2019-15-47-49)-Study-related document.pdf



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.