Over-night Effect of Dietary Fiber on Glucose Metabolism and Satiety
Primary Purpose
Obesity, Metabolic Syndrome
Status
Completed
Phase
Early Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
High levels of indigestible carbohydrates
Low levels of indigestible carbohydrates
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
- Food allergies e.g. lactose-, gluten intolerance
- Metabolic disorder e.g. diabetes
- Tobacco/snuff users
- No antibiotic or probiotic intake 2 weeks prior and during study.
- Vegetarians
Sites / Locations
- Medicon Village
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
+ ind. CHO
- ind. CHO
Arm Description
Test meals: intake of high levels of indigestible carbohydrates the evening prior to measurements of variables
Reference meal: scarce intake of indigestible carbohydrates the evening prior to measurements of variables
Outcomes
Primary Outcome Measures
Blood Glucose, levels of glucose in blood
Insulin, levels of insulin in blood
Appetite hormones, levels of Peptide YY (PYY) in blood
Markers of colonic fermentation, levels of hydrogen in breath
Inflammation markers, levels of Interleukin-6 (IL-6) in blood
Secondary Outcome Measures
Subjective satiety, as measured by VAS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02347293
Brief Title
Over-night Effect of Dietary Fiber on Glucose Metabolism and Satiety
Official Title
Indigestible Carbohydrates in an Over-night Design as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (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, over-night, study where the purpose is to evaluate food factors related to colonially derived regulation 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
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
+ ind. CHO
Arm Type
Experimental
Arm Description
Test meals: intake of high levels of indigestible carbohydrates the evening prior to measurements of variables
Arm Title
- ind. CHO
Arm Type
Experimental
Arm Description
Reference meal: scarce intake of indigestible carbohydrates the evening prior to measurements of variables
Intervention Type
Other
Intervention Name(s)
High levels of indigestible carbohydrates
Intervention Type
Other
Intervention Name(s)
Low levels of indigestible carbohydrates
Primary Outcome Measure Information:
Title
Blood Glucose, levels of glucose in blood
Time Frame
Postprandial 0-180 min after breakfast
Title
Insulin, levels of insulin in blood
Time Frame
Postprandial 0-180 min after breakfast
Title
Appetite hormones, levels of Peptide YY (PYY) in blood
Time Frame
Postprandial 0-180 min after breakfast
Title
Markers of colonic fermentation, levels of hydrogen in breath
Time Frame
Postprandial 0-180 min after breakfast
Title
Inflammation markers, levels of Interleukin-6 (IL-6) in blood
Time Frame
Postprandial 0-180 min after breakfast
Secondary Outcome Measure Information:
Title
Subjective satiety, as measured by VAS
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
Food allergies e.g. lactose-, gluten intolerance
Metabolic disorder e.g. diabetes
Tobacco/snuff users
No antibiotic or probiotic intake 2 weeks prior and during 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
Medicon Village
City
Lund
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
29338758
Citation
Gyll J, Ridell K, Ohlund I, Karlsland Akeson P, Johansson I, Lif Holgerson P. Vitamin D status and dental caries in healthy Swedish children. Nutr J. 2018 Jan 16;17(1):11. doi: 10.1186/s12937-018-0318-1.
Results Reference
derived
PubMed Identifier
28431559
Citation
Sandberg JC, Bjorck IME, Nilsson AC. Effects of whole grain rye, with and without resistant starch type 2 supplementation, on glucose tolerance, gut hormones, inflammation and appetite regulation in an 11-14.5 hour perspective; a randomized controlled study in healthy subjects. Nutr J. 2017 Apr 21;16(1):25. doi: 10.1186/s12937-017-0246-5.
Results Reference
derived
Learn more about this trial
Over-night Effect of Dietary Fiber on Glucose Metabolism and Satiety
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