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

Primary Purpose

Obesity, Metabolic Syndrome

Status

Completed

Phase

Early Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

High levels of indigestible carbohydrates

Low levels of indigestible carbohydrates

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Medicon Village

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

+ ind. CHO

- ind. CHO

Arm Description

Test meals: intake of high levels of indigestible carbohydrates the evening prior to measurements of variables

Reference meal: scarce intake of indigestible carbohydrates the evening prior to measurements of variables

Outcomes

Primary Outcome Measures

Blood Glucose, levels of glucose in blood

Insulin, levels of insulin in blood

Appetite hormones, levels of Peptide YY (PYY) in blood

Markers of colonic fermentation, levels of hydrogen in breath

Inflammation markers, levels of Interleukin-6 (IL-6) in blood

Secondary Outcome Measures

Subjective satiety, as measured by VAS

Full Information

NCT ID

NCT02347293

First Posted

January 15, 2015

Last Updated

May 26, 2015

Sponsor

Lund University

1. Study Identification

Unique Protocol Identification Number

NCT02347293

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lund University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Metabolic Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

+ ind. CHO

Arm Type

Experimental

Arm Description

Test meals: intake of high levels of indigestible carbohydrates the evening prior to measurements of variables

Arm Title

- ind. CHO

Arm Type

Experimental

Arm Description

Reference meal: scarce intake of indigestible carbohydrates the evening prior to measurements of variables

Intervention Type

Other

Intervention Name(s)

High levels of indigestible carbohydrates

Intervention Type

Other

Intervention Name(s)

Low levels of indigestible carbohydrates

Primary Outcome Measure Information:

Title

Blood Glucose, levels of glucose in blood

Time Frame