Effect of Oligofructose on Appetite in Overweight Subjects
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|ClinicalTrials.gov Identifier: NCT00912197|
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : December 30, 2020
Last Update Posted : January 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Appetite Regulation Obesity||Dietary Supplement: Oligofructose Dietary Supplement: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy Overweight Subjects|
|Actual Study Start Date :||June 2009|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
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.
Dietary Supplement: Oligofructose
Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.
Placebo Comparator: 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.
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
- Subjective Appetite Ratings in Hunger Compared to Baseline [ Time Frame: Baseline, 56 days ]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
- Subjective Appetite Ratings in Fullness Compared to Baseline [ Time Frame: Baseline, 56 days ]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
- Body Weight [ Time Frame: Baseline, 56 days ]
- Energy Intake [ Time Frame: Baseline, 56 days ]
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).
- Gut Hormone PYY [ Time Frame: baseline (Day 0) and post-supplementation (Day 56) ]Total PYY concentrations were quantified using specific and sensitive in-house radio-immunoassays as previously described.
- Body Composition [ Time Frame: Baseline, 56 days ]Body composition assessed by BMI
- Imaging of Total Adipose Tissue [ Time Frame: Baseline, 56 days ]Total adipose tissue was assessed by FMRI at baseline and after treatment period
- Plasma Short-chain Fatty Acids Concentrations After Treatment [ Time Frame: Baseline, 56 days ]Short-chain fatty acids (acetate, propionate, butyrate) concentrations assessed from plasma at 56 days at 450min timepoint with gas chromatography
- Inflammatory Markers [ Time Frame: baseline (Day 0) and post-supplementation (Day 56) ]No data were collected for this Outcome Measure
- Glycemic Response [ Time Frame: baseline (Day 0) and post-supplementation (Day 56) ]Glucose was analyzed in the Department of Clinical Biochemistry, Hammer-smith Hospital, London using an Abbott Architect ci8200 analyzer(Abbott Diagnostics, Maidenhead, UK).
- Serum Insulin [ Time Frame: baseline (Day 0) and post-supplementation (Day 56) ]Plasma insulin concentrations were assayed using RIA kits (Millipore, MO).
- Breath Hydrogen Levels [ Time Frame: baseline (Day 0) and post-supplementation (Day 56) ]breath hydrogen were obtained from volunteers throughout the study session.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912197
|Imperial College London, Hammersmith Hospital|
|London, United Kingdom, W12 0NN|
|Principal Investigator:||Gary S Frost||Imperial College London|