Over-night Effect of Dietary Fiber on Glucose Metabolism and Satiety
Indigestible Carbohydrates in an Over-night Design as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 obesity
Started Oct 2014
Shorter than P25 for early_phase_1 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 15, 2015
CompletedFirst Posted
Study publicly available on registry
January 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 27, 2015
May 1, 2015
7 months
January 15, 2015
May 26, 2015
Conditions
Outcome Measures
Primary Outcomes (5)
Blood Glucose, levels of glucose in blood
Postprandial 0-180 min after breakfast
Insulin, levels of insulin in blood
Postprandial 0-180 min after breakfast
Appetite hormones, levels of Peptide YY (PYY) in blood
Postprandial 0-180 min after breakfast
Markers of colonic fermentation, levels of hydrogen in breath
Postprandial 0-180 min after breakfast
Inflammation markers, levels of Interleukin-6 (IL-6) in blood
Postprandial 0-180 min after breakfast
Secondary Outcomes (1)
Subjective satiety, as measured by VAS
Postprandial 0-180 min after breakfast
Study Arms (2)
+ ind. CHO
EXPERIMENTALTest meals: intake of high levels of indigestible carbohydrates the evening prior to measurements of variables
- ind. CHO
EXPERIMENTALReference meal: scarce intake of indigestible carbohydrates the evening prior to measurements of variables
Interventions
Eligibility Criteria
You may qualify if:
- Normal fasting blood glucose
- BMI 19-25 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
Study Sites (1)
Medicon Village
Lund, Sweden
Related Publications (2)
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.
PMID: 29338758DERIVEDSandberg 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.
PMID: 28431559DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Nilsson, PhD
Lund University
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc, postgraduate student
Study Record Dates
First Submitted
January 15, 2015
First Posted
January 27, 2015
Study Start
October 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 27, 2015
Record last verified: 2015-05