Impact of Food Combination on Starch Digestion and Gastric Processing

Appetite Clinical Trial

— DECOUVRIR-M  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265392
• Other study ID #: DECOUVRIR-M
• Status: Completed
• Phase: N/A
• Start date: January 19, 2018
• Est. completion date: July 6, 2018

Study information

• Verified date: June 2019
• Source: Institut National de la Recherche Agronomique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 6, 2018
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appetite
• Gastric Emptying
• Glycemic Index

Intervention

Other:
• Bread
Serving of wheat bread providing 50 g of carbohydrates
• Water
250 mL of water
• Lemon juice
250 mL of lemon juice
• Tea
250 mL of tea
• Peas
20 peas

Locations

Country	Name	City	State
France	Centre de Recherche sur Volontaires (CRV), Hospital Avicenne	Bobigny	Ile-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Recherche Agronomique	IR4M (Imagerie par Résonance Magnétique Médicale et Multi-Modalités)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	End of the day questionnaire	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)	12-16 hours after the test meal (Part 1 and 2)
Other	Gastric contractions	Analysis of MRI scans will be carried out to evaluate the frequency of gastric contractions.	At baseline and during 3 hours after after consuming the test meal (Part 2 only)
Other	Amylolytic activity of saliva	The amylolytic activity of saliva samples collected before the test meal will be determined.	At baseline (Part 1)
Primary	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
Primary	Gastric emptying (Main outcome of Part 2)	Gastric empting kinetics of each test-meal, evaluated by MRI, during part 2	3 hours
Secondary	Glycemic Response (Secondary outcome of Parts 1 and 2)	Capillary blood glucose monitoring	At baseline and and at different time-points during 3 hours after after consuming the test meal
Secondary	Subjective appetite sensations (Secondary outcome of Part 2)	Evaluation of satiety, fullness, hunger, prospective food consumption and desire to eat through visual analogue scales (VAS)	At baseline and at different time-points during 3 hours after consuming the test meal