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van CCT (UK)

van CCT (UK)

Short term effect of added fibre on energy intake.

- candidate number13247
- NTR NumberNTR3588
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-aug-2012
- Secondary IDs12/13 / NL40470.081.12; METC Wageningen / CCMO
- Public TitleShort term effect of added fibre on energy intake.
- Scientific TitleShort term effect of added fibre on energy intake.
- hypothesisWe hypothesize that in this short term study the testproducts with added fibre will increase satiety, slower gastric emptying, will give a later blood glucose peak and that it will decrease energy intake when compared to the controlproduct.
- Healt Condition(s) or Problem(s) studiedEating behaviour
- Inclusion criteria1. Age: 18-40 y;
2. BMI: 18.5- 25.0 kg/m2;
3. Healthy as judged by the participant himself;
4. Having signed the informed consent form.
- Exclusion criteria1. Smoking or drug abuse;
2. Pregnant or lactating women;
3. Gastro-intestinal diseases (e.g. irritable bowel syndrome, inflammatory bowel disease);
4. Diabetes, thyroid diseases or any other endocrine disorders;
5. Using an energy restricted diet during the last 2 months;
6. Using an dietary fibre supplement;
7. Weight gain or loss of > 5kg body weight in the last 2 months;
8. Lack of appetite for any reason;
9. Restraint eating DEBQ score ≥ 2.89 for men, and ≥ 3.39 for women;
10. Hypersensitivity or food allergy for products used in this study;
11. Antibiotic use < 2 months before the study;
12. Using medication other than birth control, paracetamol, acetylsalicylic acid, hay fever, asthma;
13. Thesis students or employees of the Division of Human Nutrition;
14. Having participated to the ProVe or FLiTS Studies;
15. Having a blood glucose concentration lower/higher than 4.0 8.0mmol/l.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-sep-2012
- planned closingdate28-okt-2012
- Target number of participants32
- InterventionsAfter a standard breakfast at home subjects will eat the testproduct (with added fibre or the controlproduct). There are 5 different testproducts: the type of testproduct (solid mueslibar/liquid yoghurt) and the dose of fibre (0 or 10g in the mueslibar and 0, 5 or 10g in the yoghurt) varies. Before each test session (baseline) and multiple times after eating the testproduct, subjects rate their appetite, blood glucose concentration will be measured and breath samples will be collected. Following this an ad libitum lunch is offered to the subjects.
- Primary outcomeThe primary study parameter is energy intake at the ad libitum lunch.
- Secondary outcomeSecondary parameters are subjective feelings of satiety, gastric emptying rate, and blood glucose levels.
- TimepointsEvery subject will visit the laboratory 6 times: Once for an information and screening meeting and five times for the five testsessions. Subjects will have one testsession a week with in each session:
1. An ad libitum lunch after eating the testproduct;
2. Appetite questionnaire: At baseline and multiple times after eating the testproduct;
3. Breath sample collection: At basline and multiple times after eating the testproduct;
4. Measure of bloodglucose concentration: At baseline and multiple times after eating the testproduct.
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Wageningen University, Division of Human Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Carbohydrate Competence Centre (CCC)
- PublicationsN/A
- Brief summaryIt is known that some dietary fibres are beneficial for health, and some are associated with body weight management. A lot of fibre(mixtures) are not studied and their application is often limited. However, these fibres may have beneficial effects in humans, e.g. on satiety and energy intake.
- Main changes (audit trail)
- RECORD20-aug-2012 - 20-jan-2013

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