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Clinical Trials/NCT03944343
NCT03944343
Completed
Not Applicable

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

Lund University1 site in 1 country19 target enrollmentOctober 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diet Prevention of Metabolic Diseases
Sponsor
Lund University
Enrollment
19
Locations
1
Primary Endpoint
Glucose tolerance
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2019
End Date
June 24, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anne Nilsson

Associate professor, senior lecturer

Lund University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Glucose tolerance

Time Frame: 3 hours

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 Outcomes

  • Mood parameters(3 hours)
  • Breath hydrogen(3 hours)
  • Subjective appetite variables(3 hours)

Study Sites (1)

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