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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oligofructose | Experimental | 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. |
|
| Cellulose and maltodextrin | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oligofructose | Dietary Supplement | Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Body Weight | Baseline, 56 days | |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition | Body composition assessed by BMI | Baseline, 56 days |
| Imaging of Total Adipose Tissue | Total adipose tissue was assessed by FMRI at baseline and after treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary S Frost | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London, Hammersmith Hospital | London | W12 0NN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23474087 | Result | 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. | |
| 24715424 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oligofructose | Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in. |
| FG001 | Cellulose and Maltodextrin | Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Oligofructose | Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in. |
| BG001 | Cellulose and Maltodextrin | Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Error | cm | Baseline, 56 days |
|
56 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oligofructose | Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Gary Frost | Imperial College London | +44 (0)20 7594 0959 | g.frost@imperial.ac.uk |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C120489 | oligofructose |
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| Placebo | 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 |
|
| Baseline, 56 days |
| 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 |
| Inflammatory Markers | No data were collected for this Outcome Measure | baseline (Day 0) and post-supplementation (Day 56) |
| 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) |
| Serum Insulin | Plasma insulin concentrations were assayed using RIA kits (Millipore, MO). | baseline (Day 0) and post-supplementation (Day 56) |
| Breath Hydrogen Levels | breath hydrogen were obtained from volunteers throughout the study session. | baseline (Day 0) and post-supplementation (Day 56) |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| waist:hip ratio (WHR) | Mean | Standard Deviation | ratio |
|
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|
|
| 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 | Posted | Mean | Standard Error | units on a scale | Baseline, 56 days |
|
|
|
|
| Primary | Body Weight | Posted | Mean | Standard Error | kg | 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). | Posted | Mean | Standard Error | kcal | Baseline, 56 days |
|
|
|
|
| Primary | Gut Hormone PYY | Total PYY concentrations were quantified using specific and sensitive in-house radio-immunoassays as previously described. | The PI has left the institution. There is no access to the raw data, we only have access to the graphical data in publication (please see: 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. PubMed ID: 24715424 for graph) | Posted | baseline (Day 0) and post-supplementation (Day 56) |
|
|
| Secondary | Body Composition | Body composition assessed by BMI | Posted | Mean | Standard Error | kg/m^2 | Baseline, 56 days |
|
|
|
| Secondary | Imaging of Total Adipose Tissue | Total adipose tissue was assessed by FMRI at baseline and after treatment period | Posted | Mean | Standard Error | percentage of body fat | 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 | Posted | Mean | Standard Error | uM | Baseline, 56 days |
|
|
|
|
| Secondary | Inflammatory Markers | No data were collected for this Outcome Measure | Inflammatory markers where never measured for this study and so therefore no results available. | Posted | 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). | Posted | Mean | 95% Confidence Interval | mmol/L | baseline (Day 0) and post-supplementation (Day 56) |
|
|
|
| Secondary | Serum Insulin | Plasma insulin concentrations were assayed using RIA kits (Millipore, MO). | Posted | Mean | 95% Confidence Interval | (mU/L | baseline (Day 0) and post-supplementation (Day 56) |
|
|
|
| Secondary | Breath Hydrogen Levels | breath hydrogen were obtained from volunteers throughout the study session. | The PI has left the institution. There is no access to the raw data, we only have access to the graphical data in publication (please see: 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. PubMed ID: 24715424 for graph) | Posted | baseline (Day 0) and post-supplementation (Day 56) |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Cellulose and Maltodextrin | Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in | 0 | 10 | 0 | 10 | 0 | 10 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Superiority |
| baseline to after treatment, at 56 days | t-test, 2 sided | 0.05 | calculated | Superiority |
| Butyrate |
|