Effect of Fibre Products on Appetite and Weight - Full Text View

Purpose

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.

Condition	Intervention
Obesity	Dietary Supplement: Propionate ester Dietary Supplement: Inulin Dietary Supplement: Cellulose

MedlinePlus related topics:

Dietary Supplements Obesity

ChemIDplus related topics:

Insulin Cellulose Cellulose sodium phosphate Phosphocellulose Inulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Increased Short Chain Fatty Acids in the Colon Are Associated With Improved Energy Homeostasis and Insulin Sensitivity.

Further study details as provided by Imperial College London:

Primary Outcome Measures:

Appetite, [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adipose tissue distribution, [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Insulin sensitivity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	97
Study Start Date:	September 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Propionate ester: Experimental	Dietary Supplement: Propionate ester The subject will take propionate ester at the dose specified by the dose finding study, three times a day for 24 weeks
Fermentable control: Placebo Comparator	Dietary Supplement: Inulin The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks
Non fermentable control: Placebo Comparator	Dietary Supplement: Cellulose The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks.

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

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750438

Contacts


Contact: Gary Frost, PhD, BSc, RD	0208 383 3242	g.frost@imperial.ac.uk

Contact: Sagen Zac-Varghese, MBChB, MRCP, BSc	020 8383 3242	s.zac-varghese@imperial.ac.uk

Locations


United Kingdom, UK
	Hammersmith Hospital	Recruiting
	London, UK, United Kingdom, W12 0NN
	Contact: Gary Frost, PhD, BSc, 020 8383 3242 g.frost@imperial.ac.uk
	Contact: Sagen Zac-Varghese, MBChB, BSc 020 8383 3242 s.zac-varghese@imperial.ac.uk
	Principal Investigator: Gary Frost, PhD, BSc
	Sub-Investigator: Niamh Martin, MBChB, PhD
	Sub-Investigator: Sagen Zac-Varghes2, MBChB,

Sponsors and Collaborators

Imperial College London

Investigators


Principal Investigator:	Gary Frost, PhD	Imperial College London

More Information

Responsible Party:	Imperial College London ( Professor Gary Frost )
Study ID Numbers:	08/H0707/99, REC approval 08/H0707/99, R&D FROG1068
First Received:	September 9, 2008
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00750438
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

Obesity

Short chain fatty acids

Appetite

Body weight

Insulin sensitivity

Propionate

Propionate ester

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overweight

Overnutrition

Insulin

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Imperial College London
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00750438