None listed
Conditions
Brief summary
To replace the midday meal with Medlab’s W8Biotic(Trademark) product for a duration of 8 Weeks. W8Biotic(Trademark) is scientifically formulated to support lean body mass, weight management and maintain healthy blood glucose levels in healthy individuals when taken in conjunction with a calorie controlled eating plan. W8Biotic(Trademark) contains Hi-Maize Resistance Starch, which is a Type 2 Resistant Starch (RS2) with therapeutic properties that may help to increase satiety and assist with weight management. Hi-Maize is also a prebiotic and produces short-chain fatty acids that help to support healthy gastrointestinal function. Leucine is a branched-chain amino acid that assists in the metabolic regulation of healthy blood glucose levels and in supporting skeletal muscle protein synthesis in healthy individuals. W8Biotic(Trademark) also contains Lactobacillus plantarum and Lactobacillus paracasei that naturally synthesise alpha-hydroxy isocaproic acid (HICA) from leucine, which is indicated to support lean muscle mass in healthy individuals. Furthermore, L-carnitine assists with modulating energy expenditure in healthy individuals.
Interventions
Study aims to confirm the safety and efficacy of substituting the midday meal with a meal replacement shake (W8Biotic) in clinically overweight and obese adult volunteers for a period of 8 weeks. Participants will self-administer 1 scoop (25g) of W8Biotic in 250mL of water at midday each day for 56 days. Meals consumed morning and night will be participants choice, and will be precisely recorded via a food diary. Clinical Trial coordinator will deliver intervention to qualifying participants. Pa
Study aims to confirm the safety and efficacy of substituting the midday meal with a meal replacement shake (W8Biotic) in clinically overweight and obese adult volunteers for a period of 8 weeks. Participants will self-administer 1 scoop (25g) of W8Biotic in 250mL of water at midday each day for 56 days. Meals consumed morning and night will be participants choice, and will be precisely recorded via a food diary. Clinical Trial coordinator will deliver intervention to qualifying participants. Participants will be monitored by a daily consumption diary and the return of empty tub. W8Biotic ingredients: 25 g (1 scoop) dose = 200.8Kj Hi-Maize Resistant Starch 20 g L-leucine 2 g Levocarnitine Tartrate 1.5 g Equiv. Levocarnitine 1 g Lactobacillus plantarum 10 Billion CFU Lactobacillus paracasei 10 Billion CFU
Sponsors
Medlab Clinical
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Participants > 18 years of age at time of entry on study 2) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment 3) Participants agree to undergo venepuncture on multiple occasions 4) Participants agree to adhere to the study protocol 5) BMI range of 28-35 kg/m2 6) Caucasian Ethnicity 7) No history of any chronic diseases
Exclusion criteria
1) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs 2) Active substance abuse (alcohol or drug dependency) 3) Participants who have less than three meals / day 4) The use of any illicit drugs 5) Pregnant or nursing an infant 6) The current use of any dietary and/or herbal supplements
Outcome results
None listed