None listed
Conditions
Brief summary
Being overweight affects more than 1 billion adults worldwide and it is reaching epidemic proportions in Australia. Snacking is commonly associated with an excessive intake of high-fat and high-sugar foods, and is considered to be a predisposing factor to obesity. Even being mildly to moderately overweight (body mass index [BMI], 25-28 kg/m2) increases the risk of complications such as type 2 diabetes, hypertension and kidney disease. Although participating in calorie reduced weight loss programs and correcting inappropriate eating habits (i.e. by increasing fibre and protein content) are often sufficient in people who are moderately overweight; maintaining adequate nutrition habits over time is often difficult and thus leads to weight regain. Probiotic Super Green Powder™ is a new commercially available nutritional supplement that contains white kidney bean, blood orange and green tea extracts in addition to probiotics (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum). These active ingredients have been reported to have body weight reduction effects when looked at individually in scientific investigations. Based on these investigations, it has been hypothesized that a supplement containing a cocktail of these ingredients would influence weight reduction and snacking behaviours. The primary purpose of this study is to assess the potential benefit of using Probiotic Super Green Powder™ to sustain the commitment of overweight people trying to control their body weight over an 8-week period. The specific aims of the study will determine the effects of an 8-week supplementation period from either a Probiotic Super Green Powder™ supplement or a placebo and subsequent 4-week follow up on: - Food cravings, food preference, snacking behaviours and mood status - Body mass, body composition and waist circumference - Gut microbiota - Serum concentrations of lipid levels (including triglycerides and cholesterol) and glucose - Serum concentrations of inflammation and hormonal regulators of appetite (including C-reactive protein, ghrelin and insulin)
Interventions
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 = 3
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.
Sponsors
RMIT Univerisity
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
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)
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.
Outcome results
None listed