Obesity and other hyperalimentation Nutritional, Metabolic, Endocrine
Conditions
Interventions
Current intervention as of 20/01/2022:
Method of randomisation: minimisation
Either IPE or a control dietary fibre will be given to 270 volunteers in 10 g sachets and they will be asked to take one s
Sponsors
Imperial College of Science, Technology and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 22/04/2021: 1. Males and females aged 20-40 years 2. BMI of 24-27 kg/m2 if of South Asian ethnicity or 25-30 kg/m2 if non-South Asian, and at least one of the following: 2.1. A self-reported weight gain of 2 kg or more over the last 12 months 2.2. Low self-reported physical activity (‘inactive’ or ‘minimally active’ as per IPAQ) 2.3. Low self-reported fruit and vegetable intake (1 serving per day) 3. On stable medication (if taking any) at point of screening 4. Written informed consent _____ Previous inclusion criteria: 1. Males and females aged 20-35 years 2. BMI of 24-27kg/m2 if of South Asian ethnicity or 25-30kg/m2 if non-South Asian, and at least one of the following: 2.1. A self-reported weight gain of 2kg or more over the last 12 months 2.2. Low self-reported physical activity (‘inactive’ or ‘minimally active’ as per IPAQ) 2.3. Low self-reported fruit and vegetable intake ( 1 serving per day) 3. On stable medication (if taking any) at point of screening 4. Written informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 04/01/2022: 1. Diagnosed with chronic disease: Type I and II diabetes, cancer, renal failure, heart disease, organic acidaemia (propionic acidaemia, methyl malonic acidaemia) 2. Diagnosed gastrointestinal condition including coeliac disease, inflammatory bowel disease and irritable bowel syndrome 3. Previous bowel reconstruction surgery 4. Pregnancy or lactation 5. Use of antibiotics at any time in the past 3 months 6. Untreated Vitamin B12 deficiency (<160 ng/l) 7. Taking part in a weight loss program or consuming a weight loss product 8. Have lost 3 kg or more in the last 3 months 9. Any other gastrointestinal upset (such as diarrhoea/constipation in the last 2 weeks,abdominal cramping etc) 10. Any other reason in the opinion of the investigator For sub-study: 1. Known anaemia or as per screening blood results (haemoglobin levels of <130 g/l for males and <110 g/l for females) 2. Allergies or intolerances to any of the ingredients in the set sub-study meals _____ Previous exclusion criteria: 1. Diagnosed chronic disease; Type I and II diabetes, cancer, renal failure, heart disease, organic acidaemia (propionic acidaemia, methyl malonic acidaemia) 2. Diagnosed gastrointestinal condition including coeliac disease, inflammatory bowel disease and irritable bowel syndrome 3. Previous bowel reconstruction surgery 4. Pregnancy or lactation 5. Use of antibiotics at any time in the past 3 months 6. Anaemic AND Vitamin B12 deficient (< 160 ng/L) 7. Taking part in a weight loss program or consuming a weight loss product 8. Have lost 3kg or more in the last 3 months 9. Any other gastrointestinal upset (such as diarrhoea/constipation in the last 2 weeks, abdominal cramping etc) 10. Any other reason in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight gain (clinic measured weight) from baseline to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 20/01/2022: 1. Occurrence of Adverse Events and Serious Adverse Events (self reported and asked during study visits) over the duration of the study 2. Changes in fasting biochemistry (blood results of samples taken during study visits) from baseline to 6 and 12 months: 2.1. Glucose 2.2. Insulin 2.3. Triglycerides 2.4. Total cholesterol 2.5. Low Density Lipoprotein (LDL) cholesterol 2.6. High Density Lipoprotein (HDL) cholesterol 3. Changes in blood pressure (clinic measured BP) from baseline to 2, 6 and 12 months 4. Changes in body weight (clinic measured weight) from baseline to 2 and 6 months 5. Changes in waist/hip/BMI/body composition measurements - Fat Mass (FM), Fat Mass Index (FMI), percent body fat (Fat%), fat free body mass, (FFM) and FM/FFM ratio (clinic measurements and clinic measured bioelectrical impedance) from baseline to 2, 6 and 12 months 6. Changes in appetite (7-day food diary completion) from baseline, to 2, 6 and 12 months 7. Changes in compliance (returned used/unused sachets count) from baseline to 2, 6 and 12 months 8. Changes in diet (7-day food diary completion) during the 12 month intervention 9. Changes in physical activity during the 12 month intervention 10. Changes in other lifestyle factors during the 12 month intervention; smoking, drinking and recreational drugs Sub-study (exploratory/mechanistic): 1. To explore the effects of IPE on colonic metabolism using metataxonomic analysis of the 16S ribosomal ribonucleic acid (rRNA) gene in stool samples, to identify the relative abundance of the bacterial component of the microbiome. 2. To explore the effects of IPE on the metabolite profile using nuclear magnetic resonance spectroscopic analyses. These data will be used to determine how these specific changes in the colonic environment influence L-cell differentiation using a human organoid model. 3. To explore the effects of IPE on anorectic gut hormones (GLP-1, PYY, gastrin and CCK) and subje | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed