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Fiber Longer Term Study on Energy Intake

The Effect of 2 Weeks of Supplementation of a High-gelling, High-viscous Dietary Fibre on Energy Intake

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01526759
Acronym
FLiTS
Enrollment
35
Registered
2012-02-06
Start date
2011-12-31
Completion date
2012-03-31
Last updated
2012-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

dietary fiber, energy intake, satiety, physicochemical properties, men and women, Healthy adults

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.

Interventions

DIETARY_SUPPLEMENTLM pectin (10%)

15 days 1 daily consumption of a drink with 10g pectin added

DIETARY_SUPPLEMENTgelatin

15 days 1 daily consumption of a drink with 10g gelatin added

Sponsors

Wageningen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Energy intakechange from placebo after 2 weeksafter 14 days of both intervention and placebo supplements ad libitum energy intake is measured for 3 days in a row. The change in energy intake will be calculated.

Secondary

MeasureTime frameDescription
fasting glucosechange from placebo after day 0, 1 and 15at day 0, 1 and day 15 of supplementation period fasting glucose is measured
fasting insulinchange from placebo after day 0, 1 and 15at day 0, 1 and day 15 of supplementation period fasting insulin is measured
fasting leptinchange from placebo after day 0, 1 and 15at day 0, 1 and day 15 of supplementation period fasting leptin is measured
satietychange from placebo after 1 day and 15 daysat day 1 and after 15 days of both supplement and placebo intake satiety is measured hourly over 1 day at waking hours. The change in satiety will be calculated.
energy intakechange from placebo after day 0 and 1before supplement intake and after 1 day of supplement 1-day ad libitum energy intake is measured. The change in energy intake will be calculated.
body weightchange from placebo after day 0,1,2,14,15, 16 and 17Each day the subject reports to the research center, body weight is measured. The change in body weight compared to placebo will be calculated.
adverse eventsdaily from day 0 to day 16participants will be asked to register adverse events daily in a diary. They are also asked to report ae's to the researchers. number and type of AEs after fibre supplements will be compared to number and type of AEs after placebo supplements
hydrogen in breathchange from placebo after day 2 and 15at day 2 and at day 15 hydrogen is measured hourly over 1 day at waking hours

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026