Effects of Dietary Fibre on Glucose Metabolism and Satiety

June 25, 2014 updated by: Jonna Sandberg, Lund University

Intrinsic Indigestible Carbohydrates as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety

The experimental model is a semi-acute study where the purpose of the study is to evaluate food factors related to colonially derived regulation of glucose metabolism (and related parameters) and satiety in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • SE
      • Lund, SE, Sweden, 221 00
        • Applied Nutrition and Food Chemistry, Lund Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal fasting blood glucose, BMI 19-25 kg/m2

Exclusion Criteria:

  • Gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during study. Vegetarians.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: + ind. CHO + prim
Test meal: ate intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming)
Other: Test meal
Other: Priming
The reference or test meal was eaten 3 days prior to measurements of variables.
Experimental: - ind. CHO + prim
Reference:ate no intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming)
Other: Priming
The reference or test meal was eaten 3 days prior to measurements of variables.
Other: Reference
Experimental: + ind. CHO - prim
Test meal: ate intrinsic indigestible carbohydrates 1 day prior to measurements of variables (no priming)
Other: Test meal
Other: No priming
The reference or test meal was eaten 1 days prior to measurements of variables.
Experimental: - ind. CHO - prim
Reference: ate no indigestible carbohydrates the day prior to measurements of variables (no priming).
Other: Reference
Other: No priming
The reference or test meal was eaten 1 days prior to measurements of variables.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose
Time Frame: Postprandial 0-180 min after breakfast
The test products are both ingested one day and three days prior to measurements of variables.
Postprandial 0-180 min after breakfast
Insulin
Time Frame: Postprandial 0-180 min after breakfast
The test products are both ingested one day and three days prior to measurements of variables.
Postprandial 0-180 min after breakfast
Appetite hormones
Time Frame: Postprandial 0-180 min after breakfast
The test products are both ingested one day and three days prior to measurements of variables.
Postprandial 0-180 min after breakfast
Markers of colonic fermentation and inflammation
Time Frame: Postprandial 0-180 min after breakfast
The test products are both ingested one day and three days prior to measurements of variables.
Postprandial 0-180 min after breakfast

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective satiety
Time Frame: Postprandial 0-180 min after breakfast
The measures of hunger, satiety, and desire to eat with the use of a VAS were determined every hour throughout the postprandial testing sessions.
Postprandial 0-180 min after breakfast

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Investigators

  • Principal Investigator: Anne Nilsson, PhD, Lund Univeristy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 10, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Estimate)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr2013/241

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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