Properties of Dietary Fibre and Energy Intake

Healthy Male Subjects Clinical Trial

— ProVe  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257295
• Other study ID #: METC-10/22
• Status: Completed
• Phase: N/A
• First received: December 8, 2010
• Last updated: December 23, 2011
• Start date: December 2010
• Est. completion date: May 2011

Study information

• Verified date: December 2011
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• 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

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Dietary Supplement:
• control: no fiber addition
liquid breakfast without addition of fiber
• breakfast with low viscous, low gelling pectin
10g of low viscous, low gelling pectin dissolved in a liquid breakfast
• high viscous, low gelling pectin
10g of high viscous, low gelling pectin dissolved in a liquid breakfast
• low viscous, high gelling pectin
10g of low viscous, high gelling pectin dissolved in a liquid breakfast
• high viscous, high gelling pectin
10g of high viscous, high gelling pectin dissolved in a liquid breakfast
• pectin supplement
10g of high viscous, high gelling pectin provided as a dietary supplement, a liquid breakfast is served seperately

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	3 hours after ingesting the test breakfast ad libitum energy intake is measured.	3 hours	No
Secondary	appetite sensations	appetite is measured by VAS scales over a period of 3 hours after ingestion of a test breakfast	3 hours	No
Secondary	satiety hormones	satiety hormones (ghrelin, PYY, GLP-1, CCK) are measured over a period of 3 hours after ingestion of a test breakfast	3 hours	No
Secondary	gastric emptying rate	gastric emptying rate is measured over a period of 3 hours after ingestion of a test breakfast	3 hours	No
Secondary	method of supplementation	One of the fibers will be offered as tablets that will be ingested with a glass of water right after the test meal.	3 hours	No