N/A
Completed N=60
Effect of Fibre Products on Appetite and Weight
Source: ClinicalTrials.gov NCT00750438 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Appetite_Food Intake — 678; 836; 645; 763 kcal — p=0.972
Summary
This study explores the nutritional effects of fibre. Short chain fatty acid(SCFA), such as propionate, are produced through the fermentation of fibre in the bowel. SCFA are thought to have direct beneficial effects on the gut, appetite, weight and fat distribution. This study will look into these effects by conducting a dose finding study and then a randomised controlled study using healthy human volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Appetite_Food Intake |
678; 836; 645; 763 | 0.972 |
| PRIMARY Body Weight |
91; 88.5; 91.4; 87.5 | 0.559 |
| PRIMARY Body Weight - Number of Participants Gained ≥3% of Their Baseline Body Weight |
6; 1 | 0.036 sig |
| SECONDARY Adipose Tissue Distribution - Intra-abdominal Adipose Tissue |
10.6; 13.2; 11.1; 13.1 | 0.001 sig |
| SECONDARY Insulin Sensitivity - HOMA IR |
2.7; 2; 2.3; 2 | 0.372 |
Eligibility Criteria
Inclusion Criteria
- Healthy male and female volunteers aged between 21 and 65 years
Exclusion Criteria
- Weight change of more than 3kg in the preceding 2 months
- Current smokers
- Substance abuse
- Excess alcohol intake
- Pregnancy
- Diabetes
- Cardiovascular disease
- Cancer
- Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
- Kidney disease
- Liver disease
- Pancreatitis
- Use of medications including: anti inflammatory drugs or steroids, cholesterol lowering medication, androgens, phenytoin, erythromycin or thyroid hormones.
Data sourced from ClinicalTrials.gov (NCT00750438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.