Fiber Longer Term Study on Energy Intake (FLiTS)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: LM pectin (10%); Dietary supplement: gelatin

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Wageningen, Netherlands, 7002HD
    • Wageningen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pectin; 10 gram high gelling-high viscous fiber, added to a drink	Dietary supplement: LM pectin (10%); 15 days 1 daily consumption of a drink with 10g pectin added
Placebo Comparator: control; 10g gelatin, added to a drink	Dietary supplement: gelatin; 15 days 1 daily consumption of a drink with 10g gelatin added

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy intake	after 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.	change from placebo after 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
satiety	at 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.	change from placebo after 1 day and 15 days
fasting glucose	at day 0, 1 and day 15 of supplementation period fasting glucose is measured	change from placebo after day 0, 1 and 15
fasting insulin	at day 0, 1 and day 15 of supplementation period fasting insulin is measured	change from placebo after day 0, 1 and 15
fasting leptin	at day 0, 1 and day 15 of supplementation period fasting leptin is measured	change from placebo after day 0, 1 and 15
hydrogen in breath	at day 2 and at day 15 hydrogen is measured hourly over 1 day at waking hours	change from placebo after day 2 and 15
energy intake	before supplement intake and after 1 day of supplement 1-day ad libitum energy intake is measured. The change in energy intake will be calculated.	change from placebo after day 0 and 1
body weight	Each day the subject reports to the research center, body weight is measured. The change in body weight compared to placebo will be calculated.	change from placebo after day 0,1,2,14,15, 16 and 17
adverse events	participants 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	daily from day 0 to day 16

Collaborators and Investigators

• Sponsor: Wageningen University
• Investigators: Principal Investigator: Edith Feskens, Prof, Wageningen University

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: December 23, 2011
• First Submitted That Met QC Criteria: February 1, 2012
• First Posted (Estimate): February 6, 2012

Study Record Updates

• Last Update Posted (Estimate): March 12, 2012
• Last Update Submitted That Met QC Criteria: March 9, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: energy intake; Healthy adults; satiety; dietary fiber; men and women; physicochemical properties
• Other Study ID Numbers: NL38515.081.11