Effects of Dietary Fibre on Glucose Metabolism and Satiety

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jonna Sandberg, Lund University
ClinicalTrials.gov Identifier:
NCT02093481
First received: March 10, 2014
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

The experimental model is a semi-acute study where the purpose of the study is to evaluate food factors related to colonially derived regulation of glucose metabolism (and related parameters) and satiety in healthy subjects.


Condition Intervention Phase
Obesity
Metabolic Syndrome
Other: Test meal
Other: Reference
Other: Priming
Other: No priming
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Intrinsic Indigestible Carbohydrates as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Blood glucose [ Time Frame: Postprandial 0-180 min after breakfast ] [ Designated as safety issue: No ]
    The test products are both ingested one day and three days prior to measurements of variables.

  • Insulin [ Time Frame: Postprandial 0-180 min after breakfast ] [ Designated as safety issue: No ]
    The test products are both ingested one day and three days prior to measurements of variables.

  • Appetite hormones [ Time Frame: Postprandial 0-180 min after breakfast ] [ Designated as safety issue: No ]
    The test products are both ingested one day and three days prior to measurements of variables.

  • Markers of colonic fermentation and inflammation [ Time Frame: Postprandial 0-180 min after breakfast ] [ Designated as safety issue: No ]
    The test products are both ingested one day and three days prior to measurements of variables.


Secondary Outcome Measures:
  • Subjective satiety [ Time Frame: Postprandial 0-180 min after breakfast ] [ Designated as safety issue: No ]
    The measures of hunger, satiety, and desire to eat with the use of a VAS were determined every hour throughout the postprandial testing sessions.


Enrollment: 19
Study Start Date: February 2014
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: + ind. CHO + prim
Test meal: ate intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming)
Other: Test meal Other: Priming
The reference or test meal was eaten 3 days prior to measurements of variables.
Experimental: - ind. CHO + prim
Reference:ate no intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming)
Other: Reference Other: Priming
The reference or test meal was eaten 3 days prior to measurements of variables.
Experimental: + ind. CHO - prim
Test meal: ate intrinsic indigestible carbohydrates 1 day prior to measurements of variables (no priming)
Other: Test meal Other: No priming
The reference or test meal was eaten 1 days prior to measurements of variables.
Experimental: - ind. CHO - prim
Reference: ate no indigestible carbohydrates the day prior to measurements of variables (no priming).
Other: Reference Other: No priming
The reference or test meal was eaten 1 days prior to measurements of variables.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal fasting blood glucose, BMI 19-25 kg/m2

Exclusion Criteria:

  • Gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during study. Vegetarians.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02093481

Locations
Sweden
Applied Nutrition and Food Chemistry, Lund Univeristy
Lund, SE, Sweden, 221 00
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Anne Nilsson, PhD Lund Univeristy
  More Information

No publications provided

Responsible Party: Jonna Sandberg, MSc, postgraduate student, Lund University
ClinicalTrials.gov Identifier: NCT02093481     History of Changes
Other Study ID Numbers: Dnr2013/241
Study First Received: March 10, 2014
Last Updated: June 25, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Obesity
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 20, 2014