Fiber Longer Term Study on Energy Intake

Healthy Clinical Trial

— FLiTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526759
• Other study ID #: NL38515.081.11
• Status: Completed
• Phase: N/A
• First received: December 23, 2011
• Last updated: March 9, 2012
• Start date: December 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: the Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• LM pectin (10%)
15 days 1 daily consumption of a drink with 10g pectin added
• gelatin
15 days 1 daily consumption of a drink with 10g gelatin added

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes

External Links

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