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Completed

NCT Number: NCT01526759

Fiber Longer Term Study 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.

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Key information

Conditions

Healthy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University

Wageningen, 7002HD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LM pectin (10%)

Dietary Supplement

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

gelatin

Dietary Supplement

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

Primary outcomes

  1. Energy intake

    Time frame: change from placebo after 2 weeks

    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 outcomes

  1. satiety

    Time frame: change from placebo after 1 day and 15 days

    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.

  2. fasting glucose

    Time frame: change from placebo after day 0, 1 and 15

    at day 0, 1 and day 15 of supplementation period fasting glucose is measured

  3. fasting insulin

    Time frame: change from placebo after day 0, 1 and 15

    at day 0, 1 and day 15 of supplementation period fasting insulin is measured

  4. fasting leptin

    Time frame: change from placebo after day 0, 1 and 15

    at day 0, 1 and day 15 of supplementation period fasting leptin is measured

  5. hydrogen in breath

    Time frame: change from placebo after day 2 and 15

    at day 2 and at day 15 hydrogen is measured hourly over 1 day at waking hours

  6. energy intake

    Time frame: change from placebo after day 0 and 1

    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.

  7. body weight

    Time frame: change from placebo after day 0,1,2,14,15, 16 and 17

    Each day the subject reports to the research center, body weight is measured. The change in body weight compared to placebo will be calculated.

  8. adverse events

    Time frame: daily from day 0 to day 16

    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

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Official study title

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

Acronym: FLiTS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 6, 2012
Registry last updated
Mar 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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