Over-night Effect of Dietary Fiber on Glucose Metabolism and Satiety

May 26, 2015 updated by: Jonna Sandberg, Lund University

Indigestible Carbohydrates in an Over-night Design as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety

The experimental model is a semi-acute, over-night, study where the purpose is to evaluate food factors related to colonially derived regulation and satiety in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

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
      • Lund, Sweden
        • Medicon Village

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Gastrointestinal diseases
  • Food allergies e.g. lactose-, gluten intolerance
  • Metabolic disorder e.g. diabetes
  • Tobacco/snuff users
  • No antibiotic or probiotic intake 2 weeks prior 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
Test meals: intake of high levels of indigestible carbohydrates the evening prior to measurements of variables
Other: High levels of indigestible carbohydrates
Experimental: - ind. CHO
Reference meal: scarce intake of indigestible carbohydrates the evening prior to measurements of variables
Other: Low levels of indigestible carbohydrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Glucose, levels of glucose in blood
Time Frame: Postprandial 0-180 min after breakfast
Postprandial 0-180 min after breakfast
Insulin, levels of insulin in blood
Time Frame: Postprandial 0-180 min after breakfast
Postprandial 0-180 min after breakfast
Appetite hormones, levels of Peptide YY (PYY) in blood
Time Frame: Postprandial 0-180 min after breakfast
Postprandial 0-180 min after breakfast
Markers of colonic fermentation, levels of hydrogen in breath
Time Frame: Postprandial 0-180 min after breakfast
Postprandial 0-180 min after breakfast
Inflammation markers, levels of Interleukin-6 (IL-6) in blood
Time Frame: Postprandial 0-180 min after breakfast
Postprandial 0-180 min after breakfast

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective satiety, as measured by VAS
Time Frame: Postprandial 0-180 min after breakfast
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

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

October 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 15, 2015

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr2013/241b

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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