Status:
COMPLETED
Impact of Food Combination on Starch Digestion and Gastric Processing
Lead Sponsor:
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborating Sponsors:
IR4M (Imagerie par Résonance Magnétique Médicale et Multi-Modalités)
Conditions:
Glycemic Index
Gastric Emptying
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The results of our in vitro studies strengthen the hypothesis that the contribution of salivary alpha-amylase to starch digestion has been underrated and that this enzyme can play an important role in...
Detailed Description
The main objective of this work was to test the impact of adding black tea or lemon juice to a starch-rich meal on postprandial plasma glucose concentrations and on energy intake in healthy humans. Th...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- To be overall healthy
- To be between 18 and 60 years old
- BMI between 18 and 25 (lean)
- No eating disorders
- No major weight changes (\> 3kg in previous 3 months)
- Structured eating habits (3 main meals/day, everyday)
- Not using corticoid drugs, or antidepressives known to influence food consumption, appetite and/or mood.
- Not using medication known to influence glucose tolerance: acetylsalicylic acid or thyroxin, vitamin or mineral-based dietary supplements, and drugs to control hypertension or osteoporosis are acceptable
- No allergies to the foods in the test-meals and ad libitum meal
- No abusive alcohol consumption
- No intensive exercising habits
- No participation in a clinical study within the previous 6 months
- To enjoy the foods in the test-meals and ad libitum meals
- To be affiliated to a social security system
- To be available to participate in study sessions
- To have read and signed the Informed consent form
- Additional criteria for Part 2
- Male
- Ability to be in an MRI scan without moving
- Ability to hold breath for 25s (a requirement for certain MRI exams)
- Non-inclusion criteria:
- History of diabetes, use of antihyperglycemic drugs or insulin to treat diabetes or associated conditions
- Major medical interventions or surgeries requiring hospitalization within the previous 3 months
- Any medical condition that affects digestion and/or nutrient absorption
- Use of steroids, protease inhibitors and/or antipsychotic drugs
- Use of anticoagulation drugs
- To be participating in another clinical trial, or to be within the exclusion period of a previous clinical trial
- To have started or stopped smoking within the previous 3 months
- Additional exclusion criteria for Part 2:
- Any contraindications to an MRI exam: claustrophobia, tatoos, presence of ferromagnetic elements, having a pacemaker, metallic prosthesis, cochlear implants, vascular clips, insulin pumps
- Any condition or disease that might affect the results of MRI exams.
Exclusion
Key Trial Info
Start Date :
January 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2018
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03265392
Start Date
January 19 2018
End Date
July 6 2018
Last Update
June 7 2019
Active Locations (1)
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1
Centre de Recherche sur Volontaires (CRV), Hospital Avicenne
Bobigny, Île-de-France Region, France, 93000