Overweight Nutritional, Metabolic, Endocrine
Conditions
Interventions
Prior to the start of the intervention, participants will be randomly assigned to one of the two parallel groups using block randomisation with randomly permuted blocks (2, 4, 6, or 8 block size).
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Sponsors
Phynova Group Ltd
Oxford Brookes University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Body mass index (BMI) =25 kg/m² or =29.9 kg/m² 2. Body fat percentages =20% for males, =30% for females
Exclusion criteria
Exclusion criteria: 1. Aged 60 years 2. Body mass index (BMI) 29.9 kg/m² 3. Body fat percentages 6.5% 5. Any known food allergy or intolerance to the placebo or test product 6. Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or which influence digestion and absorption of nutrients 7. Known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions 8. Major medical or surgical event requiring hospitalization within the preceding 3 months 9. Use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution) 10. Volunteers self-reporting as currently dieting (including ketogenic) or having lost >5% body weight in the previous year 11. Volunteers who have significantly changed their physical activity in the past 2-4 weeks or who intend to change during the study 12. Participation in another experimental study or receipt of an investigational drug/product within 30 days of the screening visit 13. Participants with restricted or abnormal eating behaviour 14. Regular intake of a food supplement with effects on glucose metabolism and satiety (e.g. prebiotics, proteins, chromium, cinnamon, berberine, biotin) 15. Smoker in the last 3 months 16. Heavy alcohol consumers, more than 14 units per week (14 units is equivalent to 6 pints of average-strength beer or 10 small glasses of low-strength wine)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose concentrations measured via venipuncture and CGM. Venipuncture measurements are collected at clinic visits at week 1, week 6, and week 12, and by CGMs used during weeks 1-2, and weeks 11-12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body weight measured using a body composition analyser at week 1, week 6, and week 12. 2. Body composition measured through bioimpedance using a body composition analyser at week 1, week 6, and week 12. 3. Height measured using a stadiometer at week 1, week 6, and week 12. 4. Waist and hip circumference measured using a standard non-stretch tape at week 1, week 6, and week 12. 5. Systolic and diastolic blood pressure measured using a digital blood pressure monitor at week 1, week 6, and week 12. 6. Intraday glucose variability measured for 14 days from week 1 and week 10 using continuous glucose monitors. 7. 14-day food records collected from week 1 and week 10 using the Nutritics Libro App. 8. Satiety outcomes (hunger, fullness, desire to eat, and prospective food consumption) measured over 8 hours during week 1, week 6, and week 12 using an online visual analogue scale (VAS). 9. Microbiome functional data (measurement of acetate, propionate, SCFA ratio, iso-butyrate, iso-valerate) and compositional data (total bacteria, firmicutes, bacteriodetes, lactobacillus, bifidobacterium) measured using NeoVos Advanced Gut Test at week 1 and week 12. 10. Clinical biochemistry outcomes insulin, HbA1c, blood lipids, adiponectin, leptin, inflammatory markers (CRP, TNF-a, IL-6) measured via venipuncture. Measurements are collected at clinic visits at week 1, week 6, and week 12. | — |
Countries
England, United Kingdom
Contacts
Public ContactAndrew Gallagher
Outcome results
None listed