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Prebiotic Effects on Glucose Tolerance

Primary Purpose

Diet Prevention of Metabolic Diseases

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cereal based products
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diet Prevention of Metabolic Diseases

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 18.5 - 25 kg/m2
  • age 20-40 years
  • normal diet
  • healthy

Exclusion Criteria:

  • fasting blood glucose >6.1
  • diagnosed or known disease
  • known gastrointestinal disorder
  • food allergies or intolerance
  • special diet regiments
  • smokers

Sites / Locations

  • Lund University, Food Technology, Engineering and Nutrition

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Sham Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Reference product

Test product A

Test product B

Test product C

Test product D

Arm Description

Commercial cereals and a commercial yogurt

Specific designed cereals A and yogurt

Specific designed cereals B and yogurt

Specific designed cereals C and yogurt

Specific designed cereals D and yogurt

Outcomes

Primary Outcome Measures

Glucose tolerance
The incremental (3 hours) blood glucose area under the curve after a standardized breakfast, following consumption of the test- or reference products the previous evening. Glucose concentrations will be analysed from capillary blood at fasting and at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min after the standardized breakfast.

Secondary Outcome Measures

Subjective appetite variables
Determination of appetite variables (satiety, hunger and desire to eat) at fasting in the morning and after the standardized breakfast following consumption of the test- or reference products the previous evening. The appetite sensations will be determined at fasting and then at 30 min, 60 min, 90 min, 120 min, 150 min and at 180 min. The variables will be determined by registration on a 0-100 mm visual analogue scales (VAS). Higher ratings are considered to be better for the rating of satiety meanwhile lower ratings are considered to be better for hunger and desire to eat.
Mood parameters
Determination of mood variables (activity and valence) at fasting in the morning and after the andardized breakfast, following consumption of the test- or reference products the previous evening. The mood variables will be determined at fasting and then at 60 min, 120 min and at 180 min. The variables will be determined by registration on a 0-100 mm visual analogue scales (VAS).
Breath hydrogen
Determination of breath hydrogen concentrations will be performed at fasting and after the standardized breakfast, following consumption of the test- or reference products the previous evening. Breath hydrogen will be determined at fasting and then at 30 min, 60 min, 90 min, 120 min, 150 min and at 180 min. Breath hydrogen will be measured by exhaling in a portable measuring device.

Full Information

First Posted
May 8, 2019
Last Updated
June 24, 2020
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT03944343
Brief Title
Prebiotic Effects on Glucose Tolerance
Official Title
Validation of a New Antidiabetic Food Concept Based on the Modulation of the Intestinal Flora
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The primary purpose of this project is to evaluate effects in healthy humans on glucose tolerance of cereal products with high amounts of fermentable dietary fibre. Secondary issues are to investigate effects of the test foods on subjective appetite variables, mood variables and gut microbiota composition. The test food products will be consumed in the evening and test variables will be determined the next morning. The study will apply a randomized crossover study design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet Prevention of Metabolic Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized crossover study design. Healthy young adult volunteers.
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reference product
Arm Type
Sham Comparator
Arm Description
Commercial cereals and a commercial yogurt
Arm Title
Test product A
Arm Type
Experimental
Arm Description
Specific designed cereals A and yogurt
Arm Title
Test product B
Arm Type
Experimental
Arm Description
Specific designed cereals B and yogurt
Arm Title
Test product C
Arm Type
Experimental
Arm Description
Specific designed cereals C and yogurt
Arm Title
Test product D
Arm Type
Experimental
Arm Description
Specific designed cereals D and yogurt
Intervention Type
Other
Intervention Name(s)
Cereal based products
Intervention Description
The cereal products are made from common Swedish cereals.
Primary Outcome Measure Information:
Title
Glucose tolerance
Description
The incremental (3 hours) blood glucose area under the curve after a standardized breakfast, following consumption of the test- or reference products the previous evening. Glucose concentrations will be analysed from capillary blood at fasting and at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min after the standardized breakfast.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Subjective appetite variables
Description
Determination of appetite variables (satiety, hunger and desire to eat) at fasting in the morning and after the standardized breakfast following consumption of the test- or reference products the previous evening. The appetite sensations will be determined at fasting and then at 30 min, 60 min, 90 min, 120 min, 150 min and at 180 min. The variables will be determined by registration on a 0-100 mm visual analogue scales (VAS). Higher ratings are considered to be better for the rating of satiety meanwhile lower ratings are considered to be better for hunger and desire to eat.
Time Frame
3 hours
Title
Mood parameters
Description
Determination of mood variables (activity and valence) at fasting in the morning and after the andardized breakfast, following consumption of the test- or reference products the previous evening. The mood variables will be determined at fasting and then at 60 min, 120 min and at 180 min. The variables will be determined by registration on a 0-100 mm visual analogue scales (VAS).
Time Frame
3 hours
Title
Breath hydrogen
Description
Determination of breath hydrogen concentrations will be performed at fasting and after the standardized breakfast, following consumption of the test- or reference products the previous evening. Breath hydrogen will be determined at fasting and then at 30 min, 60 min, 90 min, 120 min, 150 min and at 180 min. Breath hydrogen will be measured by exhaling in a portable measuring device.
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 18.5 - 25 kg/m2 age 20-40 years normal diet healthy Exclusion Criteria: fasting blood glucose >6.1 diagnosed or known disease known gastrointestinal disorder food allergies or intolerance special diet regiments smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Nilsson, associate professor
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University, Food Technology, Engineering and Nutrition
City
Lund
ZIP/Postal Code
22100
Country
Sweden

12. IPD Sharing Statement

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Prebiotic Effects on Glucose Tolerance

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