Increasing Inulin Propionate Ester in the gut, for prevention of weight gain in adults aged 20-40 years at higher risk of weight gain.
- Conditions
- Obesity and other hyperalimentationNutritional, Metabolic, Endocrine
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 270
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 (<2 servings of fruit and vegetables per day)
2.4. Self-reported high intake of sugar-sweetened beverages (>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 (< 2 servings of fruit and vegetables per day)
2.4. Self-reported high intake of sugar sweetened beverages (> 1 serving per day)
3. On stable medication (if taking any) at point of screening
4. Written informed consent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight gain (clinic measured weight) from baseline to 12 months
- Secondary Outcome Measures
Name Time Method