NCT01526759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 12, 2012

Status Verified

March 1, 2012

Enrollment Period

3 months

First QC Date

December 23, 2011

Last Update Submit

March 9, 2012

Conditions

Healthy

Keywords

dietary fiberenergy intakesatietyphysicochemical propertiesmen and womenHealthy adults

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • satiety

    change from placebo after 1 day and 15 days

  • fasting glucose

    change from placebo after day 0, 1 and 15

  • fasting insulin

    change from placebo after day 0, 1 and 15

  • fasting leptin

    change from placebo after day 0, 1 and 15

  • hydrogen in breath

    change from placebo after day 2 and 15

  • +3 more secondary outcomes

Study Arms (2)

pectin

EXPERIMENTAL

10 gram high gelling-high viscous fiber, added to a drink

Dietary Supplement: LM pectin (10%)

control

PLACEBO COMPARATOR

10g gelatin, added to a drink

Dietary Supplement: gelatin

Interventions

LM pectin (10%)DIETARY_SUPPLEMENT

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

pectin
gelatinDIETARY_SUPPLEMENT

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

control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-30 year
  • BMI: 18.5-25 kg/m2
  • Healthy: as judged by the participant
  • H2 producer

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, 7002HD, Netherlands

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

Gelatin

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Edith Feskens, Prof

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2011

First Posted

February 6, 2012

Study Start

December 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 12, 2012

Record last verified: 2012-03

Locations

NL(1)