Impact of Food Combination on Starch Digestion and Gastric Processing

NCT03265392 | Completed

• 1 other identifier: DECOUVRIR-M
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Glycemic Index; Gastric Emptying; Appetite

Outcome Measures

Primary Outcomes (2)

• Energy intake (Main outcome of Part 1)

  Consumption at an ad libitum meal served 3 h after each test-meal during part 1

  3 hours

• Gastric emptying (Main outcome of Part 2)

  Gastric empting kinetics of each test-meal, evaluated by MRI, during part 2

  3 hours

Secondary Outcomes (2)

• 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 meal

• Subjective appetite sensations (Secondary outcome of Part 2)

  At baseline and at different time-points during 3 hours after consuming the test meal

Other Outcomes (3)

• End of the day questionnaire

  12-16 hours after the test meal (Part 1 and 2)

• Gastric contractions

  At baseline and during 3 hours after after consuming the test meal (Part 2 only)

• Amylolytic activity of saliva

  At baseline (Part 1)

Study Arms (6)

Part 1 - Bread + Water

OTHER

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

Other: Bread; Other: Water

Part 1 - Bread + Lemon Juice

OTHER

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

Other: Bread; Other: Lemon juice

Part 1 - Bread + Tea

OTHER

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

Other: Bread; Other: Tea

Part 2 - Bread + water

OTHER

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.

Other: Bread; Other: Water; Other: Peas

Part 2 - Bread+ Lemon Juice

OTHER

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.

Other: Bread; Other: Lemon juice; Other: Peas

Part 2 - Bread+ tea

OTHER

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.

Other: Bread; Other: Tea; Other: Peas

Interventions

Bread OTHER

Serving of wheat bread providing 50 g of carbohydrates

Part 1 - Bread + Lemon Juice; Part 1 - Bread + Tea; Part 1 - Bread + Water; Part 2 - Bread + water; Part 2 - Bread+ Lemon Juice; Part 2 - Bread+ tea

Water OTHER

250 mL of water

Part 1 - Bread + Water; Part 2 - Bread + water

Lemon juice OTHER

250 mL of lemon juice

Part 1 - Bread + Lemon Juice; Part 2 - Bread+ Lemon Juice

Tea OTHER

250 mL of tea

Part 1 - Bread + Tea; Part 2 - Bread+ tea

Peas OTHER

20 peas

Part 2 - Bread + water; Part 2 - Bread+ Lemon Juice; Part 2 - Bread+ tea

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: lead
• IR4M (Imagerie par Résonance Magnétique Médicale et Multi-Modalités): collaborator

Study Sites (1)

Centre de Recherche sur Volontaires (CRV), Hospital Avicenne

Bobigny, Île-de-France Region, 93000, France

Location

Related Publications (1)

• 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.

  PMID: 35013789 DERIVED

MeSH Terms

Interventions

Bread; Water; Tea

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Plant Preparations; Biological Products; Complex Mixtures; Beverages

Study Officials

• Robert Benamouzig, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 29, 2017
• Study Start: January 19, 2018
• Primary Completion: July 6, 2018
• Study Completion: July 6, 2018
• Last Updated: June 7, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)