Effect of Fibre Products on Appetite and Weight

Not Applicable

Completed

Interventions: Dietary Supplement: Cellulose
Dietary Supplement: Propionate ester
Dietary Supplement: Inulin

Brief 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.

Detailed Description: This is a dose finding study in healthy overweight to obese human volunteers (BMI 25- 35) to find the level of oral supplementation with propionate that increases plasma propionate levels to 10x the current normal plasma level and use this dose of propionate in a randomised, placebo controlled double bind study. This study will compare propionate with fermentable and non fermentable carbohydrate. The outcome measures for this study will include assessments of appetite with feeding studies, measurement of insulin sensitivity using hyperinsulinaemic euglycaemic clamps and assessment of adipose tissue distribution using MRI scans and adipose tissue biopsy to determine changes in proliferation and differentiation of adipocytes.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Appetite_Food Intake	Baseline, 24 weeks	The change in food intake following 24 weeks of supplementation
Body Weight	Baseline, 24 weeks	Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
Body Weight - Number of Participants Gained ≥3% of Their Baseline Body Weight	Baseline, 24 weeks	Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.

Secondary Outcome Measures

Name	Time	Method
Adipose Tissue Distribution - Intra-abdominal Adipose Tissue	24 weeks	Body composition was assessed using MRI and MR spectroscopy (MRS), expressed as a percentage of total adipose tissue content.
Insulin Sensitivity - HOMA IR	24 weeks	The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function.