No registrations found.
ID
Source
Brief title
Health condition
Overweight, Obesity
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in change of body weight and fat mass between control and oligofructose group after 12 weeks of supplementation.
Secondary outcome
24-h food intake, 24-h appetite, chronic appetite, physical activity
Background summary
Rationale: Based upon fermentation processes in the intestinal tract, food containing soluble dietary fibres, such as inulin or oligofructose, may limit energy intake and decrease adiposity in humans.
Objective: To study the effect of 12 weeks of supplementation of oligofructose at a dosage of 16 g/d versus placebo on body weight and body composition in overweight and obese men and women.
Study design: A 12 week, double-blind, randomized placebo-controlled parallel study. The study population will be randomly assigned to receive one of two interventions: 1) control granola bar (no oligofructose) or 2) granola bar with added oligofructose (16 g/d). Body weight, body composition, energy intake and appetite will be measured during the study, as well as gastrointestinal function and overall acceptability of the intervention.
Study population: 60 healthy males and females aged 20 – 60 y with a BMI > 25 kg/m2.
Intervention: Subjects receive either 16 g oligofructose or no oligofructose daily for 12 weeks. The dietary supplement will be consumed as a granola bar twice a day (8 g of oligofructose or no oligofructose per bar).
Main study parameters/endpoints: Difference in change of body weight and fat mass between control and oligofructose group after 12 weeks of supplementation.
Study objective
Het lichaamsgewicht van mensen die 12 wk lang hun snacks vervangen voor muesli repen met toegevoegd OF zullen een lager lichaamsgewicht hebben dan mensen die 12 wk hun snack vervangen door een muesli reep zonder OF.
Study design
0, 1, 6, 12 wk
Intervention
Subjects receive either 16 g oligofructose or no oligofructose daily for 12 weeks. The dietary supplement will be consumed as a granola bar twice a day (8 g of oligofructose or no oligofructose per bar).
Wageningen Universiteit<br>
Postbus 8129.
Monica Mars
Wageningen 6700 EV
The Netherlands
+31 (0)317 485340
monica.mars@wur.nl
Wageningen Universiteit<br>
Postbus 8129.
Monica Mars
Wageningen 6700 EV
The Netherlands
+31 (0)317 485340
monica.mars@wur.nl
Inclusion criteria
Men and women
Age 20 – 60 years
BMI 25-35 kg/m2
Healthy: as judged by the participant
Exclusion criteria
Reported cardiovascular, liver, pancreas, renal, thyroid or gastrointestinal disease
Reported diabetes type 1
Unstable type 2 diabetes, hypertension or dyslipidaemia
Medication that can interfere with the experiment (antibiotics, appetite suppressors, weight loss supplements)
Gain or loss of more > 5 kg in the 3 months prior to study entry
Lack of appetite for any reason
Women: pregnant or lactating
Fasting glucose concentration >6.9 mmol/l
Total cholesterol >6.5 mmol/l
Triglycerides >2.2 mmol/l
Glucose or protein in urine
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3878 |
| NTR-old | NTR4075 |
| CCMO | NL45006.081.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |