Fiber Longer Term Study on Energy Intake (FLiTS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wageningen University
ClinicalTrials.gov Identifier:
NCT01526759
First received: December 23, 2011
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: LM pectin (10%)
Dietary Supplement: gelatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of 2 Weeks of Supplementation of a High-gelling, High-viscous Dietary Fibre on Energy Intake

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Energy intake [ Time Frame: change from placebo after 2 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • satiety [ Time Frame: change from placebo after 1 day and 15 days ] [ Designated as safety issue: No ]
    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.

  • fasting glucose [ Time Frame: change from placebo after day 0, 1 and 15 ] [ Designated as safety issue: No ]
    at day 0, 1 and day 15 of supplementation period fasting glucose is measured

  • fasting insulin [ Time Frame: change from placebo after day 0, 1 and 15 ] [ Designated as safety issue: No ]
    at day 0, 1 and day 15 of supplementation period fasting insulin is measured

  • fasting leptin [ Time Frame: change from placebo after day 0, 1 and 15 ] [ Designated as safety issue: No ]
    at day 0, 1 and day 15 of supplementation period fasting leptin is measured

  • hydrogen in breath [ Time Frame: change from placebo after day 2 and 15 ] [ Designated as safety issue: No ]
    at day 2 and at day 15 hydrogen is measured hourly over 1 day at waking hours

  • energy intake [ Time Frame: change from placebo after day 0 and 1 ] [ Designated as safety issue: No ]
    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.

  • body weight [ Time Frame: change from placebo after day 0,1,2,14,15, 16 and 17 ] [ Designated as safety issue: No ]
    Each day the subject reports to the research center, body weight is measured. The change in body weight compared to placebo will be calculated.

  • adverse events [ Time Frame: daily from day 0 to day 16 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 35
Study Start Date: December 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526759

Locations
Netherlands
Wageningen University
Wageningen, Netherlands, 7002HD
Sponsors and Collaborators
Wageningen University
Investigators
Principal Investigator: Edith Feskens, Prof Wageningen University
  More Information

Additional Information:
No publications provided

Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT01526759     History of Changes
Other Study ID Numbers: NL38515.081.11
Study First Received: December 23, 2011
Last Updated: March 9, 2012
Health Authority: the Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wageningen University:
dietary fiber
energy intake
satiety
physicochemical properties
men and women
Healthy adults

Additional relevant MeSH terms:
Pectin
Antidiarrheals
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014