Clinical trial NCT01526759: Fiber Longer Term Study on Energy Intake
Official title: The Effect of 2 Weeks of Supplementation of a High-gelling, High-viscous Dietary Fibre on Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: dietary fiber
energy intake
satiety
physicochemical properties
men and women
Healthy adults
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2012-02-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Dietary fibre seems to have a relevant role in body weight management. In an acute study the investigators found that high viscous-high gelling pectin increased feelings of satiety. The objective of this study is to study the effects of 2 weeks of supplementation of high gelling-high viscous fibre or a high gelling-high viscous non-fibre control on energy intake.

The investigators do this by measuring the difference in ad libitum energy intake after 15 days of pectin or 15 days of control supplements. The investigators will further measure differences in 24h feelings of satiety, fasting blood glucose and insulin, fermentation and composition of microbiota.


Eligibility criteria: Inclusion Criteria:

* Age: 18-30 year
* BMI: 18.5-25 kg/m2
* Healthy: as judged by the participant
* H2 producer

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
* Smoking
* Heavy alcohol use: \>5 drinks/day
* Reported stomach or bowel diseases or disorders (e.g. irritable bowel syndrome)
* Reported diabetes
* Reported thyroid disease or any other endocrine disorder
* Using medication other than birth control, paracetamol, aspirin, hey fever and asthma
* Antibiotic use \<2 months before the study
* Reported intolerance, allergy, or not liking of the research foods
* Vegetarian
* Current dietary fibre supplementation
* Fasting glucose levels \>5.8 mmol/l
* Experienced any problems with drawing blood in the past
* Thesis students or employees of the division of Human Nutrition
* Volunteers who participated in the ProVe study

Primary outcomes:
measure: Energy intake
timeFrame: change from placebo after 2 weeks
Secondary outcomes:
measure: satiety
timeFrame: change from placebo after 1 day and 15 days
measure: fasting glucose
timeFrame: change from placebo after day 0, 1 and 15
measure: fasting insulin
timeFrame: change from placebo after day 0, 1 and 15
measure: fasting leptin
timeFrame: change from placebo after day 0, 1 and 15
measure: hydrogen in breath
timeFrame: change from placebo after day 2 and 15
measure: energy intake
timeFrame: change from placebo after day 0 and 1
measure: body weight
timeFrame: change from placebo after day 0,1,2,14,15, 16 and 17
measure: adverse events
timeFrame: daily from day 0 to day 16
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
Study officials:
affiliation: Wageningen University
name: Edith Feskens, Prof
role: PRINCIPAL_INVESTIGATOR
References: