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Effecten van oligofructose (OF) supplementen op lichaamsgewicht en lichaamssamenstelling


- candidate number15135
- NTR NumberNTR4075
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2013
- Secondary IDsNL45006.081.13  CCMO
- Public TitleEffecten van oligofructose (OF) supplementen op lichaamsgewicht en lichaamssamenstelling
- Scientific TitleOligofructose supplementation in overweight and obese adults: effects on body weight and body composition
- ACRONYMENOF
- hypothesisHet 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.
- Healt Condition(s) or Problem(s) studiedObesity, Overweight
- Inclusion criteriaMen and women
Age 20 60 years
BMI 25-35 kg/m2
Healthy: as judged by the participant
- Exclusion criteriaReported 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2013
- planned closingdate31-dec-2013
- Target number of participants60
- InterventionsSubjects 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).
- Primary outcomeDifference in change of body weight and fat mass between control and oligofructose group after 12 weeks of supplementation.
- Secondary outcome24-h food intake, 24-h appetite, chronic appetite, physical activity
- Timepoints0, 1, 6, 12 wk
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Monica Mars
- CONTACT for SCIENTIFIC QUERIES Monica Mars
- Sponsor/Initiator Wageningen University (WUR)
- Funding
(Source(s) of Monetary or Material Support)
SENSUS
- PublicationsN/A
- Brief summaryRationale: 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.
- Main changes (audit trail)
- RECORD15-jul-2013 - 2-dec-2013


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