Back to resultsEffects of Dietary Fibre on Glucose Metabolism and Satiety
Primary Purpose
Obesity, Metabolic Syndrome
Status
Completed
Phase
Early Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Test meal
Reference
Priming
No priming
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
Eligibility 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.
Sites / Locations
- Applied Nutrition and Food Chemistry, Lund Univeristy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
+ ind. CHO + prim
- ind. CHO + prim
+ ind. CHO - prim
- ind. CHO - prim
Arm Description
Test meal: ate intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming)
Reference:ate no intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming)
Test meal: ate intrinsic indigestible carbohydrates 1 day prior to measurements of variables (no priming)
Reference: ate no indigestible carbohydrates the day prior to measurements of variables (no priming).
Outcomes
Primary Outcome Measures
Blood glucose
The test products are both ingested one day and three days prior to measurements of variables.
Insulin
The test products are both ingested one day and three days prior to measurements of variables.
Appetite hormones
The test products are both ingested one day and three days prior to measurements of variables.
Markers of colonic fermentation and inflammation
The test products are both ingested one day and three days prior to measurements of variables.
Secondary Outcome Measures
Subjective satiety
The measures of hunger, satiety, and desire to eat with the use of a VAS were determined every hour throughout the postprandial testing sessions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02093481
Brief Title
Effects of Dietary Fibre on Glucose Metabolism and Satiety
Official Title
Intrinsic Indigestible Carbohydrates as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (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 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.
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
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
+ ind. CHO + prim
Arm Type
Experimental
Arm Description
Test meal: ate intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming)
Arm Title
- ind. CHO + prim
Arm Type
Experimental
Arm Description
Reference:ate no intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming)
Arm Title
+ ind. CHO - prim
Arm Type
Experimental
Arm Description
Test meal: ate intrinsic indigestible carbohydrates 1 day prior to measurements of variables (no priming)
Arm Title
- ind. CHO - prim
Arm Type
Experimental
Arm Description
Reference: ate no indigestible carbohydrates the day prior to measurements of variables (no priming).
Intervention Type
Other
Intervention Name(s)
Test meal
Intervention Type
Other
Intervention Name(s)
Reference
Intervention Type
Other
Intervention Name(s)
Priming
Intervention Description
The reference or test meal was eaten 3 days prior to measurements of variables.
Intervention Type
Other
Intervention Name(s)
No priming
Intervention Description
The reference or test meal was eaten 1 days prior to measurements of variables.
Primary Outcome Measure Information:
Title
Blood glucose
Description
The test products are both ingested one day and three days prior to measurements of variables.
Time Frame
Postprandial 0-180 min after breakfast
Title
Insulin
Description
The test products are both ingested one day and three days prior to measurements of variables.
Time Frame
Postprandial 0-180 min after breakfast
Title
Appetite hormones
Description
The test products are both ingested one day and three days prior to measurements of variables.
Time Frame
Postprandial 0-180 min after breakfast
Title
Markers of colonic fermentation and inflammation
Description
The test products are both ingested one day and three days prior to measurements of variables.
Time Frame
Postprandial 0-180 min after breakfast
Secondary Outcome Measure Information:
Title
Subjective satiety
Description
The measures of hunger, satiety, and desire to eat with the use of a VAS were determined every hour throughout the postprandial testing sessions.
Time Frame
Postprandial 0-180 min after breakfast
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Nilsson, PhD
Organizational Affiliation
Lund Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Applied Nutrition and Food Chemistry, Lund Univeristy
City
Lund
State/Province
SE
ZIP/Postal Code
221 00
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
26990559
Citation
Sandberg JC, Bjorck IM, Nilsson AC. Rye-Based Evening Meals Favorably Affected Glucose Regulation and Appetite Variables at the Following Breakfast; A Randomized Controlled Study in Healthy Subjects. PLoS One. 2016 Mar 18;11(3):e0151985. doi: 10.1371/journal.pone.0151985. eCollection 2016.
Results Reference
derived
Learn more about this trial
Effects of Dietary Fibre on Glucose Metabolism and Satiety
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