Text Size

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
History of Changes
  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:

U.S. FDA Resources

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
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:
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 May 23, 2013