Prebiotics as a Means to Modulate Gut Fermentation, Metabolism, Appetite and Cognition
Prebiotics as Means to Modulate Colonic Events, With the Purpose to Increase Beneficial Effects on Metabolism, Satiety and Cognition.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Oct 2010
Typical duration for early_phase_1
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, 2010
CompletedFirst Submitted
Initial submission to the registry
October 9, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMay 8, 2013
May 1, 2013
2.4 years
October 9, 2012
May 7, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Post-prandially after breakfast, 0-150 min
Secondary Outcomes (2)
Cognitive performance
Post-prandially after breakfast, 0-210 min
Subjective satiety
post-prandially after breakfast, 0-150 min
Study Arms (2)
indigestible carbohydrates
EXPERIMENTALtest meal: indigestible carbohydrates
reference
EXPERIMENTALreference meal: no indigestible carbohydrates
Interventions
Eligibility Criteria
You may qualify if:
- BMI 19-28 kg/m2
You may not qualify if:
- gastrointestinal diseases
- metabolic disorders
- tobacco/snuff user
- antibiotic/probiotic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
Study Sites (1)
Applied Nutrition and Food Chemistry, Lund University
Lund, SE-221 00, Sweden
Related Publications (1)
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.
PMID: 26259632DERIVED
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
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc, postgraduate student
Study Record Dates
First Submitted
October 9, 2012
First Posted
October 31, 2012
Study Start
October 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
May 8, 2013
Record last verified: 2013-05