Effect of Oligofructose on Appetite in Overweight Subjects

NCT ID: NCT00912197

Last Updated: 2021-01-14

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Appetite Regulation Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Oligofructose

Participants received 10g of Oligofructose powdered supplements in sachets each containing 10 g dietary fiber) three times per day. Volunteers were instructed to take the supplement with their main meals.The 8-week supplementation period took place between visits 3 and 4 and included a 2-week run-in period to allow the bowel to adapt to the 30 g of dietary fiber.

Group Type EXPERIMENTAL

Oligofructose

Intervention Type DIETARY_SUPPLEMENT

Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.

Cellulose and maltodextrin

Participants received 10g of Cellulose powdered supplements in sachets each containing 10 g dietary fiber) three times per day. Volunteers were instructed to take the supplement with their main meals. Maltodextrin was added to the cellulose supplement. The 8-week supplementation period took place between visits 3 and 4 and included a 2-week run-in period to allow the bowel to adapt to the 30 g of dietary fiber.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Oligofructose

Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary S Frost

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College London, Hammersmith Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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/j.appet.2013.02.017. Epub 2013 Mar 5.

Reference Type RESULT
PMID: 23474087 (View on PubMed)

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;22(6):1430-8. doi: 10.1002/oby.20754. Epub 2014 Apr 8.

Reference Type RESULT
PMID: 24715424 (View on PubMed)

Other Identifiers

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CRO1243

Identifier Type: -

Identifier Source: org_study_id

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