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Role of Colonic Events on Metabolism and Appetite Control: A Synbiotic Approach

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elin Johansson, Lund University
ClinicalTrials.gov Identifier:
NCT01718418
First received: October 9, 2012
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Obesity
Metabolic Syndrome
Other: test meal
Other: reference
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Prebiotics and Probiotics 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:
  • Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal. [ Time Frame: Post-prandially after breakfast, 0-210 min ] [ Designated as safety issue: No ]
    Variables (blood glucose, insulin, incretin, inflammatory markers, markers of colonic fermentation) are measured after two-weeks ingestion of test products. The experimental day is terminated after a lunch meal.


Secondary Outcome Measures:
  • voluntary energy intake [ Time Frame: Post-prandially after breakfast, 0-210 min ] [ Designated as safety issue: No ]
    Energy intake at lunch is measured after two-weeks ingestion of test products. The experimental day is terminated after the lunch meal.

  • Subjective satiety [ Time Frame: post-prandially after breakfast, 0-210 min ] [ Designated as safety issue: No ]
    The subjective sensation of satiety, hunger and desire to eat is measured using a (VAS) questionnaire.

  • Differences in gut microbiota [ Time Frame: Faecal samples are collected after 14 days intake of test- and reference product ] [ Designated as safety issue: No ]
    The effect on gut microbiota of 14 days intake of test- and reference product are investigated in faecal samples.


Enrollment: 21
Study Start Date: September 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: + ind.CHO + prebiotics
test meal: intrinsic indigestible carbohydrates in combination with a combined probiotic supplement.
Other: test meal
Experimental: + ind.CHO - prebiotics
test meal: intrinsic indigestible carbohydrates in combination with placebo probiotic supplement.
Other: test meal
Experimental: - ind.CHO - prebiotics
reference: no ind. carbohydrates and no probiotic supplement
Other: reference

  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, for women: hormon based contraceptives

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 the 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: NCT01718418

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

No publications provided

Responsible Party: Elin Johansson, MSc, post-graduate student, Lund University
ClinicalTrials.gov Identifier: NCT01718418     History of Changes
Other Study ID Numbers: Dnr2010/457
Study First Received: October 9, 2012
Last Updated: May 7, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014