Impact of Food Combination on Starch Digestion and Gastric Processing

NCT ID: NCT03265392

Last Updated: 2019-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-19
• Study Completion Date: 2018-07-06

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.

Conditions

Glycemic Index; Gastric Emptying; Appetite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Part 1 - Bread + Water

Participants in this arm will randomly consume bread and 250 mL of water on 1 out of 3 visits of Part 1.

Group Type: OTHER

Bread

Intervention Type: OTHER

Serving of wheat bread providing 50 g of carbohydrates

Water

Intervention Type: OTHER

250 mL of water

Part 1 - Bread + Lemon Juice

Participants in this arm will randomly consume bread and 250 mL of lemon juice on 1 out of 3 visits of Part 1.

Group Type: OTHER

Bread

Intervention Type: OTHER

Serving of wheat bread providing 50 g of carbohydrates

Lemon juice

Intervention Type: OTHER

250 mL of lemon juice

Part 1 - Bread + Tea

Participants in this arm will randomly consume bread and 250 mL of tea on 1 out of 3 visits of Part 1.

Group Type: OTHER

Bread

Intervention Type: OTHER

Serving of wheat bread providing 50 g of carbohydrates

Tea

Intervention Type: OTHER

250 mL of tea

Part 2 - Bread + water

Participants in this arm will randomly consume bread and 250 mL of water supplemented with 20 peas on 1 out of 3 visits of Part 2.

Group Type: OTHER

Bread

Intervention Type: OTHER

Serving of wheat bread providing 50 g of carbohydrates

Water

Intervention Type: OTHER

250 mL of water

Peas

Intervention Type: OTHER

20 peas

Part 2 - Bread+ Lemon Juice

Participants in this arm will randomly consume bread and 250 mL of lemon juice supplemented with 20 peas on 1 out of 3 visits of Part 2.

Group Type: OTHER

Bread

Intervention Type: OTHER

Serving of wheat bread providing 50 g of carbohydrates

Lemon juice

Intervention Type: OTHER

250 mL of lemon juice

Peas

Intervention Type: OTHER

20 peas

Part 2 - Bread+ tea

Participants in this arm will randomly consume bread and 250 mL of tea supplemented with 20 peas on 1 out of 3 visits of Part 2.

Group Type: OTHER

Bread

Intervention Type: OTHER

Serving of wheat bread providing 50 g of carbohydrates

Tea

Intervention Type: OTHER

250 mL of tea

Peas

Intervention Type: OTHER

20 peas

Interventions

Bread

Serving of wheat bread providing 50 g of carbohydrates

Intervention Type: OTHER

Water

250 mL of water

Intervention Type: OTHER

Lemon juice

250 mL of lemon juice

Intervention Type: OTHER

Tea

250 mL of tea

Intervention Type: OTHER

Peas

20 peas

Intervention Type: OTHER

Eligibility Criteria

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)

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IR4M (Imagerie par Résonance Magnétique Médicale et Multi-Modalités)

UNKNOWN

Sponsor Role: collaborator

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role: lead

Responsible Party

Robert Benamouzig

Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Benamouzig, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Locations

Centre de Recherche sur Volontaires (CRV), Hospital Avicenne

Bobigny, Île-de-France Region, France

Countries

France

References

Freitas D, Boue F, Benallaoua M, Airinei G, Benamouzig R, Lutton E, Jourdain L, Dubuisson RM, Maitre X, Darrasse L, Le Feunteun S. Glycemic response, satiety, gastric secretions and emptying after bread consumption with water, tea or lemon juice: a randomized crossover intervention using MRI. Eur J Nutr. 2022 Apr;61(3):1621-1636. doi: 10.1007/s00394-021-02762-2. Epub 2022 Jan 11.

Reference Type: DERIVED

PMID: 35013789 (View on PubMed)

Other Identifiers

DECOUVRIR-M

Identifier Type: -

Identifier Source: org_study_id