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Impact of Food Combination on Starch Digestion and Gastric Processing

Digestion: Building a Better Health and Better Understanding the Digestive Processes Thanks to Magnetic Resonance Imaging

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03265392
Acronym
DECOUVRIR-M
Enrollment
28
Registered
2017-08-29
Start date
2018-01-19
Completion date
2018-07-06
Last updated
2019-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycemic Index, Gastric Emptying, Appetite

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 this process. As a result, its inhibition could constitute an opportunity to reduce the glycemic response elicited by starch-rich foods. The main goal of this study is to verify whether inhibiting salivary alpha-amylase upon the consumption of starchy foods, can have an impact on the postprandial glycemic response, and/or satiety.

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. This study was divided into two parts. The objective of part 1 was to determine the effect of pairing a starch-rich food with water, black tea or lemon juice on postprandial plasma glucose and energy intake in healthy humans. This study was conducted in semi-controlled conditions. The three test meals (equal portions of bread (100 g) and 250 mL of either water, black tea or lemon juice) were consumed as breakfast (after a 10-h fast) on independent days and in a randomised order. Capillary blood glucose concentrations were self-monitored using the finger-prick method at pre-defined time-points during 180 min. Ad libitum energy intake was assessed 3 hours later. The main objective of part 2 was to investigate whether the gastric emptying patterns remain, or not, the same when a bread meal is paired with water, tea, and lemon juice. Blood glucose response and satiety perceptions were also monitored. The test meals were similar to those in branch 1, except that the meals were supplemented with 20 peas, which the subjects were asked to swallow at the end (with half of the beverage provided) without chewing. These peas conferred a distinct contrast in MRI scans and could be used as stomach motility and gastric mixing tracers in MRI images. Capillary blood glucose concentrations were determined using the finger-prick method at pre-defined time-points during 180 min. Visual analogue scales were used to assess satiety-related perceptions. Volunteer recruitment was conducted independently for each part of the study and volunteers were allowed to participate in one part of the study only. Data collected in each part of the study was analysed independently.

Interventions

OTHERPeas

20 peas

OTHERBread

Serving of wheat bread providing 50 g of carbohydrates

OTHERWater

250 mL of water

250 mL of lemon juice

OTHERTea

250 mL of tea

Sponsors

IR4M (Imagerie par Résonance Magnétique Médicale et Multi-Modalités)
CollaboratorUNKNOWN
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Energy intake (Main outcome of Part 1)3 hoursConsumption at an ad libitum meal served 3 h after each test-meal during part 1
Gastric emptying (Main outcome of Part 2)3 hoursGastric empting kinetics of each test-meal, evaluated by MRI, during part 2

Secondary

MeasureTime frameDescription
Glycemic Response (Secondary outcome of Parts 1 and 2)At baseline and and at different time-points during 3 hours after after consuming the test mealCapillary blood glucose monitoring
Subjective appetite sensations (Secondary outcome of Part 2)At baseline and at different time-points during 3 hours after consuming the test mealEvaluation of satiety, fullness, hunger, prospective food consumption and desire to eat through visual analogue scales (VAS)

Other

MeasureTime frameDescription
Gastric contractionsAt baseline and during 3 hours after after consuming the test meal (Part 2 only)Analysis of MRI scans will be carried out to evaluate the frequency of gastric contractions.
Amylolytic activity of salivaAt baseline (Part 1)The amylolytic activity of saliva samples collected before the test meal will be determined.
End of the day questionnaire12-16 hours after the test meal (Part 1 and 2)Digital questionnaire that will be answered at the end of the day in order to provide a reference point regarding the potential effects of the test-meal throughout the rest of the day (ex. appetite, food consumption, discomfort sensations)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026