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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Prebiotic Effects on Glucose Tolerance

Clinicaltrials.gov identifier NCT03944343

Recruitment Status Completed

First Posted May 9, 2019

Last update posted June 25, 2020

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.

  • Condition or Disease:Diet Prevention of Metabolic Diseases
  • Intervention/Treatment: Other: Cereal based products
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 19 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Intervention Model Description: Randomized crossover study design. Healthy young adult volunteers.
  • Masking: Single (Participant)
  • Primary Purpose: Prevention
  • Official Title: Validation of a New Antidiabetic Food Concept Based on the Modulation of the Intestinal Flora
  • Actual Study Start Date: October 2019
  • Actual Primary Completion Date: June 2020
  • Actual Study Completion Date: June 2020
Arms and interventions
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.
Outcome Measures
  • Primary Outcome Measures: 1. 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 Outcome Measures: 1. Subjective appetite variables [ Time Frame: 3 hours ]
    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.
  • 2. Mood parameters [ Time Frame: 3 hours ]
    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. Breath hydrogen [ Time Frame: 3 hours ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 20 to 40 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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

Contacts and Locations
Contacts
Locations

Sweden
Lund University, Food Technology, Engineering and Nutrition
Lund

Sponsors and Collaborators

Lund University

Investigators

Principal Investigator: Anne Nilsson, associate professor Lund University

More Information
  • Responsible Party: Lund University
  • ClinicalTrials.gov Identifier: NCT03944343 History of Changes
  • Other Study ID Numbers: 2018/1
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: June 25, 2020
  • Last Verified: June 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Metabolic Diseases