Effect of Oligofructose on Appetite in Overweight Subjects

Obesity Clinical Trial

Official title:

Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy Overweight Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912197
• Other study ID #: CRO1243
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: August 2011

Study information

• Verified date: January 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to look into the effects of oligofructose supplementation on appetite, energy intake, and body weight and body composition in overweight subjects. Compared to a placebo product (cellulose) oligofructose is hypothesised to suppress hunger and thereby reduce food intake moderately leading to a decrease in body weight.

Description:

Appetite regulation plays an important part in energy balance. Suppressing appetite by manipulating the diet is a safe way of reducing energy intake and body weight compared to drug therapy and obesity surgery. How various nutrients affect appetite is not fully understood. Non-digestible carbohydrates (NDC) may affect appetite differently due to differences in physio-chemical properties.

This project will look into how two different NDC affect appetite and energy intake in overweight individuals in a randomised, double-blinded, placebo controlled parallel study. The NDC under investigation are oligofructose and cellulose, both natural compounds of plant origin. The former is broken down (fermented) in the large bowel by friendly bacteria producing various compounds that may affect appetite and the metabolism of the host.

Volunteers will consume one of the two NDC for eight weeks (including a two week run-in period). Appetite study session, functional MRI (fMRI) and MRI body fat scans will be conducted before and after the supplementation with NDC (or during the supplementation in the case of fMRI). Using fMRI the effect of the NDC supplementation on central appetite regulating centres will be investigated. Appetite questionnaires and dietary records will completed under free-living conditions at baseline and during the supplementation to explore the effect on subjective appetite feelings and energy intake, respectively.

It is hoped that this project will enhance the understanding of how NDC affect appetite and provide further information on how fermentation of NDC, gut hormone release, body composition, and appetite regulation are linked.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy males and females aged 20-50

• BMI 25-35 kg/m2

• Weight stable for three months prior to enrollment in study (weight change < 3 kg over a period of three months)

• Habitual dietary fibre = 25g/day (as assessed by 3-day dietary record)

• Non-smokers

• No current or history of endocrine disease, gastrointestinal disease, kidney or liver diseases, cardiovascular disease, pancreatitis, or cancer

• Hydrogen producers

Exclusion Criteria:

• Use of antibiotic less than three months prior to participation in the study

• Participation in other research studies in the previous three months

• Blood donation less than three months before participation in study

• Anaemia

• Hypertension

• Pregnancy or breastfeeding

• Substance abuse

• Vegan diet

• Regular use of prebiotic, probiotic or symbiotic food items/ supplements

• Intense exercise undertaken for more than 5h per week

• Metallic or electronic implants e.g. pacemaker, cochlear ear implants, fixed dental braces

• Claustrophobia

• Depression

Related Conditions & MeSH terms

• Appetite Regulation
• Obesity
• Overweight

Intervention

Dietary Supplement:
• Oligofructose
Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.
• Placebo
Participants will be asked to consume 3 doses (a total of 30g dietary fibres) of the placebo product daily for six weeks after a 2-week run-in

Locations

Country	Name	City	State
United Kingdom	Imperial College London, Hammersmith Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Daud NM, Ismail NA, Thomas EL, Fitzpatrick JA, Bell JD, Swann JR, Costabile A, Childs CE, Pedersen C, Goldstone AP, Frost GS. The impact of oligofructose on stimulation of gut hormones, appetite regulation and adiposity. Obesity (Silver Spring). 2014 Jun; — View Citation

Pedersen C, Lefevre S, Peters V, Patterson M, Ghatei MA, Morgan LM, Frost GS. Gut hormone release and appetite regulation in healthy non-obese participants following oligofructose intake. A dose-escalation study. Appetite. 2013 Jul;66:44-53. doi: 10.1016/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Appetite Ratings in Hunger Compared to Baseline	Hunger was assessed by visual analogue scales (Each scale is 10cm in length with words anchored at each end, expressing the most positive (Minimum score = 0 cm and means no hunger) and the most negative rating (Maximum score = 10 cm and means very hungry). Compared to baseline after treatment at 56 days	Baseline, 56 days
Primary	Subjective Appetite Ratings in Fullness Compared to Baseline	Fullness are assessed by visual analogue scale, 10 cm in length with words anchored at each end, expressing the most positive (feel full: maximum Score=10cm) and the most negative rating (feeling empty: Minimum Score = 0cm), values at baseline and after treatments at 56 days	Baseline, 56 days
Primary	Body Weight		Baseline, 56 days
Primary	Energy Intake	Energy intake was assessed by 7-days food diary at baseline and last week of treatment, diaries were analysed by Dietplan6 software.; The values in the table represent the Energy intake as measured over the whole week (as opposed to reporting the Energy intake per day based on the 7 day data).	Baseline, 56 days
Primary	Gut Hormone PYY	Total PYY concentrations were quantified using specific and sensitive in-house radio-immunoassays as previously described.	baseline (Day 0) and post-supplementation (Day 56)
Secondary	Body Composition	Body composition assessed by BMI	Baseline, 56 days
Secondary	Imaging of Total Adipose Tissue	Total adipose tissue was assessed by FMRI at baseline and after treatment period	Baseline, 56 days
Secondary	Plasma Short-chain Fatty Acids Concentrations After Treatment	Short-chain fatty acids (acetate, propionate, butyrate) concentrations assessed from plasma at 56 days at 450min timepoint with gas chromatography	Baseline, 56 days
Secondary	Inflammatory Markers	No data were collected for this Outcome Measure	baseline (Day 0) and post-supplementation (Day 56)
Secondary	Glycemic Response	Glucose was analyzed in the Department of Clinical Biochemistry, Hammer-smith Hospital, London using an Abbott Architect ci8200 analyzer(Abbott Diagnostics, Maidenhead, UK).	baseline (Day 0) and post-supplementation (Day 56)
Secondary	Serum Insulin	Plasma insulin concentrations were assayed using RIA kits (Millipore, MO).	baseline (Day 0) and post-supplementation (Day 56)
Secondary	Breath Hydrogen Levels	breath hydrogen were obtained from volunteers throughout the study session.	baseline (Day 0) and post-supplementation (Day 56)