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

Primary Purpose

Obesity, Metabolic Syndrome

Status
Completed
Phase
Early Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
test meal
reference
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Applied Nutrition and Food Chemistry, Lund University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

+ ind.CHO + prebiotics

+ ind.CHO - prebiotics

- ind.CHO - prebiotics

Arm Description

test meal: intrinsic indigestible carbohydrates in combination with a combined probiotic supplement.

test meal: intrinsic indigestible carbohydrates in combination with placebo probiotic supplement.

reference: no ind. carbohydrates and no probiotic supplement

Outcomes

Primary Outcome Measures

Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal.
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
Energy intake at lunch is measured after two-weeks ingestion of test products. The experimental day is terminated after the lunch meal.
Subjective satiety
The subjective sensation of satiety, hunger and desire to eat is measured using a (VAS) questionnaire.
Differences in gut microbiota
The effect on gut microbiota of 14 days intake of test- and reference product are investigated in faecal samples.

Full Information

First Posted
October 9, 2012
Last Updated
May 7, 2013
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT01718418
Brief Title
Role of Colonic Events on Metabolism and Appetite Control: A Synbiotic Approach
Official Title
Prebiotics and Probiotics as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
+ ind.CHO + prebiotics
Arm Type
Experimental
Arm Description
test meal: intrinsic indigestible carbohydrates in combination with a combined probiotic supplement.
Arm Title
+ ind.CHO - prebiotics
Arm Type
Experimental
Arm Description
test meal: intrinsic indigestible carbohydrates in combination with placebo probiotic supplement.
Arm Title
- ind.CHO - prebiotics
Arm Type
Experimental
Arm Description
reference: no ind. carbohydrates and no probiotic supplement
Intervention Type
Other
Intervention Name(s)
test meal
Intervention Type
Other
Intervention Name(s)
reference
Primary Outcome Measure Information:
Title
Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal.
Description
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.
Time Frame
Post-prandially after breakfast, 0-210 min
Secondary Outcome Measure Information:
Title
voluntary energy intake
Description
Energy intake at lunch is measured after two-weeks ingestion of test products. The experimental day is terminated after the lunch meal.
Time Frame
Post-prandially after breakfast, 0-210 min
Title
Subjective satiety
Description
The subjective sensation of satiety, hunger and desire to eat is measured using a (VAS) questionnaire.
Time Frame
post-prandially after breakfast, 0-210 min
Title
Differences in gut microbiota
Description
The effect on gut microbiota of 14 days intake of test- and reference product are investigated in faecal samples.
Time Frame
Faecal samples are collected after 14 days intake of test- and reference product

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Nilsson, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Applied Nutrition and Food Chemistry, Lund University
City
Lund
ZIP/Postal Code
SE-221 00
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
28531784
Citation
Nilsson A, Johansson-Boll E, Sandberg J, Bjorck I. Gut microbiota mediated benefits of barley kernel products on metabolism, gut hormones, and inflammatory markers as affected by co-ingestion of commercially available probiotics: a randomized controlled study in healthy subjects. Clin Nutr ESPEN. 2016 Oct;15:49-56. doi: 10.1016/j.clnesp.2016.06.006. Epub 2016 Jul 2.
Results Reference
derived

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

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