Effect of Oligofructose on Appetite in Overweight Subjects
1 other identifier
interventional
28
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 2, 2009
CompletedFirst Posted
Study publicly available on registry
June 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
December 30, 2020
CompletedJanuary 14, 2021
January 1, 2021
2.2 years
June 2, 2009
October 24, 2019
January 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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)
Secondary Outcomes (7)
Body Composition
Baseline, 56 days
Imaging of Total Adipose Tissue
Baseline, 56 days
Plasma Short-chain Fatty Acids Concentrations After Treatment
Baseline, 56 days
Inflammatory Markers
baseline (Day 0) and post-supplementation (Day 56)
Glycemic Response
baseline (Day 0) and post-supplementation (Day 56)
- +2 more secondary outcomes
Study Arms (2)
Oligofructose
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College London, Hammersmith Hospital
London, W12 0NN, United Kingdom
Related Publications (2)
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.
PMID: 23474087RESULTDaud 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.
PMID: 24715424RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof Gary Frost
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Gary S Frost
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2009
First Posted
June 3, 2009
Study Start
June 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
January 14, 2021
Results First Posted
December 30, 2020
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share