Text Size

Properties of Dietary Fibre and Energy Intake (ProVe)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wageningen University
ClinicalTrials.gov Identifier:
NCT01257295
First received: December 8, 2010
Last updated: December 23, 2011
Last verified: December 2011
History of Changes
  Purpose

Dietary fibers likely have a role in body weight management. They may increase satiety and, as a consequence, reduce energy intake during the next meal. There are, however, many different types of dietary fiber, which have diverse physical properties and can therefore impact these outcomes differently. It is, however, unclear whether dietary fibers with different properties lead to differences in energy intake during the next meal. The objective of this study is to study the effect of pectin in 4 different physicochemical states on ad libitum energy intake and possible underlying mechanisms; i.e. gastrointestinal hormones, gastric emptying rate, feelings of satiety and the method of fiber supplementation. We hypothesize that viscous and gelling fibers will reduce ad libitum energy intake compared to low viscous and low gelling fibers.


Condition Intervention
Healthy Male Subjects
 Dietary Supplement: control: no fiber addition
Dietary Supplement: breakfast with low viscous, low gelling pectin
Dietary Supplement: high viscous, low gelling pectin
Dietary Supplement: low viscous, high gelling pectin
Dietary Supplement: high viscous, high gelling pectin
Dietary Supplement: pectin supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Properties of Dietary Fibre and Energy Intake: an Intervention to Study the Effect of Physicochemical Properties of Dietary Fibre on Energy Intake and Underlying Mechanisms

Resource links provided by NLM:

Drug Information available for: Pectin
U.S. FDA Resources

Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • energy intake [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    3 hours after ingesting the test breakfast ad libitum energy intake is measured.


Secondary Outcome Measures:
  • appetite sensations [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    appetite is measured by VAS scales over a period of 3 hours after ingestion of a test breakfast

  • satiety hormones [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    satiety hormones (ghrelin, PYY, GLP-1, CCK) are measured over a period of 3 hours after ingestion of a test breakfast

  • gastric emptying rate [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    gastric emptying rate is measured over a period of 3 hours after ingestion of a test breakfast

  • method of supplementation [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    One of the fibers will be offered as tablets that will be ingested with a glass of water right after the test meal.


Enrollment: 29
Study Start Date: December 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: control
No additions of fiber to a breakfast meal
 Dietary Supplement: control: no fiber addition
liquid breakfast without addition of fiber
Active Comparator: low viscous, low gelling
low viscous, low gelling fibre added to breakfast meal
 Dietary Supplement: breakfast with low viscous, low gelling pectin
10g of low viscous, low gelling pectin dissolved in a liquid breakfast
Active Comparator: high viscous, low gelling
high viscous, low gelling fibre added to breakfast meal
 Dietary Supplement: high viscous, low gelling pectin
10g of high viscous, low gelling pectin dissolved in a liquid breakfast
Active Comparator: low viscous, high gelling
low viscous, high gelling fibre added to breakfast meal
 Dietary Supplement: low viscous, high gelling pectin
10g of low viscous, high gelling pectin dissolved in a liquid breakfast
Active Comparator: high viscous, high gelling
high viscous, high gelling fibre added to breakfast meal
 Dietary Supplement: high viscous, high gelling pectin
10g of high viscous, high gelling pectin dissolved in a liquid breakfast
Active Comparator: fibre supplement
high viscous, high gelling fibre is added, not to the breakfast meal, but as supplement
 Dietary Supplement: pectin supplement
10g of high viscous, high gelling pectin provided as a dietary supplement, a liquid breakfast is served seperately

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Females
  • 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: >2.89, measured by DEBQ (35).
  • Smoking
  • Heavy alcohol use: >5 drinks/day (36).
  • Reported stomach or bowel disease
  • Reported diabetes
  • Reported thyroid disease or any other endocrine disorder
  • Reported intolerance for pectin, bread, gluten, dairy or not liking of the research foods
  • Anemia: Hb<8.0 mmol/l
  • Fasting glucose levels >5.8 mmol/l
  • Blood donation from 6 weeks prior to the study until the end of the study
  • Experienced any problems with drawing blood in the past
  • Antecubital veins not considered suitable for blood drawing by means of a catheter
  • Thesis students or employees of the division of Human Nutrition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257295

Locations
Netherlands
Wageningen University
Wageningen, Netherlands, 6702
Sponsors and Collaborators
Wageningen University
Investigators
Principal Investigator: Edith Feskens, PHd Wageningen University
  More Information

No publications provided

Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT01257295     History of Changes
Other Study ID Numbers: METC-10/22
Study First Received: December 8, 2010
Last Updated: December 23, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wageningen University:
dietary fiber
energy intake
appetite
 satiety hormones
glucose
gastric emptying

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

ClinicalTrials.gov processed this record on June 17, 2013