Increasing Inulin Propionate Ester in the gut, for prevention of weight gain in adults aged 20-40 years at higher risk of weight gain.

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: Method of randomisation: minimisation Either IPE or a control dietary fibre will be given to 270 volunteers in 10g sachets and they will be asked to take one sachet per day with their normal diet for 12 months. The volunteers will attend study visits at 2, 6 and 12 months. CONDITION: Obesity and other hyperalimentation ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: Weight gain (clinic measured weight) from baseline to 12 months SECONDARY OUTCOME: ; 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) from baseline, to 2, 6 and 12 months; 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
Epistemonikos ID: 802b23ec7aae7f97a22674dace47579def9a4a86
First added on: Aug 24, 2024