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Prebiotics as a Means to Modulate Gut Fermentation, Metabolism, Appetite and Cognition

Primary Purpose

Metabolic Syndrome

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

About this trial

This is an interventional basic science trial for Metabolic Syndrome

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 19-28 kg/m2

Exclusion Criteria:

  • gastrointestinal diseases
  • metabolic disorders
  • tobacco/snuff user
  • antibiotic/probiotic treatment

Sites / Locations

  • Applied Nutrition and Food Chemistry, Lund University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

indigestible carbohydrates

reference

Arm Description

test meal: indigestible carbohydrates

reference meal: no indigestible carbohydrates

Outcomes

Primary Outcome Measures

Area under the plasma concentration versus time curve (AUC) of the test meal
The differences in AUC between different risk markers, assessed in plasma or serum,after intake of the test meal in comparison to the reference meal is measured. Example of variables measured are glucose, insulin, appetite hormones, inflammatory markers, markers of colonic fermentation.

Secondary Outcome Measures

Cognitive performance
The cognitive performance of the test subjects is measured to investigate work memory and specific attention.
Subjective satiety
The subjective sensation of satiety, hunger and desire to eat is measured using a questionnaire.

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
NCT01718431
Brief Title
Prebiotics as a Means to Modulate Gut Fermentation, Metabolism, Appetite and Cognition
Official Title
Prebiotics as Means to Modulate Colonic Events, With the Purpose to Increase Beneficial Effects on Metabolism, Satiety and Cognition.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (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
This study aims at investigating the impact of colonic fermentation of intrinsic indigestible carbohydrates in cereal whole kernels after three days consumption, on metabolic variables and cognition. The study is performed in healthy, normal to slightly over-weight test subjects.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
indigestible carbohydrates
Arm Type
Experimental
Arm Description
test meal: indigestible carbohydrates
Arm Title
reference
Arm Type
Experimental
Arm Description
reference meal: no indigestible carbohydrates
Intervention Type
Other
Intervention Name(s)
test meal
Intervention Type
Other
Intervention Name(s)
reference meal
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC) of the test meal
Description
The differences in AUC between different risk markers, assessed in plasma or serum,after intake of the test meal in comparison to the reference meal is measured. Example of variables measured are glucose, insulin, appetite hormones, inflammatory markers, markers of colonic fermentation.
Time Frame
Post-prandially after breakfast, 0-150 min
Secondary Outcome Measure Information:
Title
Cognitive performance
Description
The cognitive performance of the test subjects is measured to investigate work memory and specific attention.
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 questionnaire.
Time Frame
post-prandially after breakfast, 0-150 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 19-28 kg/m2 Exclusion Criteria: gastrointestinal diseases metabolic disorders tobacco/snuff user antibiotic/probiotic treatment
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
26259632
Citation
Nilsson AC, Johansson-Boll EV, Bjorck IM. Increased gut hormones and insulin sensitivity index following a 3-d intervention with a barley kernel-based product: a randomised cross-over study in healthy middle-aged subjects. Br J Nutr. 2015 Sep 28;114(6):899-907. doi: 10.1017/S0007114515002524. Epub 2015 Aug 11.
Results Reference
derived

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Prebiotics as a Means to Modulate Gut Fermentation, Metabolism, Appetite and Cognition

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