Prebiotic Effects on Glucose Tolerance

Validation of a New Antidiabetic Food Concept Based on the Modulation of the Intestinal Flora

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.

Study Overview

• Status: Completed
• Conditions: Diet Prevention of Metabolic Diseases
• Intervention / Treatment: Other: Cereal based products

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22100
    • Lund University, Food Technology, Engineering and Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Reference product; Commercial cereals and a commercial yogurt	Other: Cereal based products; The cereal products are made from common Swedish cereals.
Experimental: Test product A; Specific designed cereals A and yogurt	Other: Cereal based products; The cereal products are made from common Swedish cereals.
Experimental: Test product B; Specific designed cereals B and yogurt	Other: Cereal based products; The cereal products are made from common Swedish cereals.
Experimental: Test product C; Specific designed cereals C and yogurt	Other: Cereal based products; The cereal products are made from common Swedish cereals.
Experimental: Test product D; Specific designed cereals D and yogurt	Other: Cereal based products; The cereal products are made from common Swedish cereals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 hours
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).	3 hours
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.	3 hours

Collaborators and Investigators

• Sponsor: Lund University
• Investigators: Principal Investigator: Anne Nilsson, associate professor, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): June 24, 2020

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: 2018/1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No