Obesity Clinical Trial
Official title:
Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy Overweight Subjects
NCT number | NCT00912197 |
Other study ID # | CRO1243 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2009 |
Est. completion date | August 2011 |
Verified date | January 2021 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College London, Hammersmith Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
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
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) |
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