To study the effects of 2 weeks of supplementation with high gelling-high viscous fibre on energy intake in healthy subjects compared to a placebo with similar texture.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
verzadiging, energiebalans
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameter: difference in ad libitum energy intake between 15 days of
pectin or placebo supplements.
Secondary outcome
Secondary parameters: differences in 24h feelings of satiety, fasting blood
glucose, insulin and leptin, body weight, fermentation, composition of
microflora, and differences in acute effects of fibre intake.
Background summary
Dietary fibre seems to have a relevant role in body weight management. In an
acute study we found that high viscous-high gelling pectin increased feelings
of satiety. It is hypothesized that, as a consequence of increased feelings of
satiety, the fibre may reduce energy intake on a longer term.
Study objective
To study the effects of 2 weeks of supplementation with high gelling-high
viscous fibre on energy intake in healthy subjects compared to a placebo with
similar texture.
Study design
Double blind, randomized crossover trial with 2 treatments. Each subject will
ingests 2 times 15 subsequent days either placebo or pectin supplements on top
of their regular diet. The first 2 days and the last 3 days of each treatment
period ad libitum energy intake will be measured.
Intervention
The supplements will consist of a low energy dairy product. The supplemented
fibre is 10g high-gelling-high viscous pectin. The placebo is gelatin, to
provoke a similar texture. Gelatin will be digested in the upper
gastrointestinal tract.
Study burden and risks
The intervention is non-therapeutic to the participant. The risk associated
with participation is negligible and the burden can be considered as moderate.
At screening the following measurements and questionnaires will be taken:
inclusion questionnaire (1x), Dutch Eating Behaviour Questionnaire (1x),
height, weight (1x), fasting glucose (1x). During the intervention study over 2
periods of 16 days, subjects will take dietary supplements each day once, and
come to the university on 5 days in both periods to consume all meals provided
by us. Between the 2 periods there is a wash out period of 2 weeks. In both
intervention periods the following measurements and questionnaires will be
taken: appetite/satiety questionnaires over 1 day waking hours (2x), breath
samples over 1 day waking hours (2x), blood samples (3x), fecal samples (2x),
body weight (5x), and a pedometer is worn for 5 days.
Bomenweg 4
6703 HD Wageningen
NL
Bomenweg 4
6703 HD Wageningen
NL
Listed location countries
Age
Inclusion criteria
• Age: 18-30 year
• BMI: 18.5-25 kg/m2
• Healthy: as judged by the participant
Exclusion criteria
• Weight loss or weight gain of more than 5 kg during the last 2 months
• Using an energy restricted diet during the last 2 months
• Lack of appetite for any reason
• Restrained eater: for men >2.89 and for women >3.39, measured by DEBQ
• Smoking
• Heavy alcohol use: >5 drinks/day
• Reported stomach or bowel disease (e.g. IBS)
• Reported diabetes
• Reported thyroid disease or any other endocrine disorder
• Using medication other than birth control, paracetamol, aspirine, hey feaver and asthma
• Antibiotic use <2 months before the study
• Current dietary fibre supplementation
• Fasting glucose levels >5.8 mmol/l
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 |
|---|---|
| CCMO | NL38515.081.11 |