Clinical trial NCT00750438: Effect of Fibre Products on Appetite and Weight
Official title: Increased Short Chain Fatty Acids in the Colon Are Associated With Improved Energy Homeostasis and Insulin Sensitivity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Short chain fatty acids
Appetite
Body weight
Insulin sensitivity
Propionate
Propionate ester
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2008-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Appetite_Food Intake
timeFrame: Baseline, 24 weeks
measure: Body Weight
timeFrame: Baseline, 24 weeks
measure: Body Weight - Number of Participants Gained ≥3% of Their Baseline Body Weight
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Adipose Tissue Distribution - Intra-abdominal Adipose Tissue
timeFrame: 24 weeks
measure: Insulin Sensitivity - HOMA IR
timeFrame: 24 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital
state: UK
Study officials:
affiliation: Imperial College London
name: Gary Frost, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chambers ES, Viardot A, Psichas A, Morrison DJ, Murphy KG, Zac-Varghese SE, MacDougall K, Preston T, Tedford C, Finlayson GS, Blundell JE, Bell JD, Thomas EL, Mt-Isa S, Ashby D, Gibson GR, Kolida S, Dhillo WS, Bloom SR, Morley W, Clegg S, Frost G. Effects of targeted delivery of propionate to the human colon on appetite regulation, body weight maintenance and adiposity in overweight adults. Gut. 2015 Nov;64(11):1744-54. doi: 10.1136/gutjnl-2014-307913. Epub 2014 Dec 10.
citation: Byrne CS, Chambers ES, Alhabeeb H, Chhina N, Morrison DJ, Preston T, Tedford C, Fitzpatrick J, Irani C, Busza A, Garcia-Perez I, Fountana S, Holmes E, Goldstone AP, Frost GS. Increased colonic propionate reduces anticipatory reward responses in the human striatum to high-energy foods. Am J Clin Nutr. 2016 Jul;104(1):5-14. doi: 10.3945/ajcn.115.126706. Epub 2016 May 11.