Glycemic IndexDECOUVRIR-MNCT03265392
Impact of Food Combination on Starch Digestion and Gastric Processing
A study testing Bread, Water and Lemon juice in people with Glycemic Index and Gastric Emptying, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index, Gastric Emptying, Appetite
- What is being tested?
- Bread, Water and Lemon juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2018to 6 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 31Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche sur Volontaires (CRV), Hospital Avicenne
Bobigny, Île-de-France Region, 93000
About this study
Official title: Digestion: Building a Better Health and Better Understanding the Digestive Processes Thanks to Magnetic Resonance Imaging
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.
Read the 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
- Being tested
- Bread, Water, Lemon juice, Tea, Peas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreadOther
Serving of wheat bread providing 50 g of carbohydrates
WaterOther
250 mL of water
Lemon juiceOther
250 mL of lemon juice
TeaOther
250 mL of tea
PeasOther
20 peas
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Bread; Other: Tea; Other: Peas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake (Main outcome of Part 1)
Consumption at an ad libitum meal served 3 h after each test-meal during part 1
Measured: 3 hours
Gastric emptying (Main outcome of Part 2)
Gastric empting kinetics of each test-meal, evaluated by MRI, during part 2
Measured: 3 hours
Secondary outcomes (2)
Glycemic Response (Secondary outcome of Parts 1 and 2)
Capillary blood glucose monitoring
Measured: 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)
Evaluation of satiety, fullness, hunger, prospective food consumption and desire to eat through visual analogue scales (VAS)
Measured: At baseline and at different time-points during 3 hours after consuming the test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start19 Jan 2018
- Primary completion6 Jul 2018
- Study completion6 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glycemic IndexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- IR4M (Imagerie par Résonance Magnétique Médicale et Multi-Modalités)
- Responsible party
- Principal investigator, Robert Benamouzig, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- Robert Benamouzig, MD, PhD, Principal investigator, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265392
- Sponsor's protocol ID
- DECOUVRIR-M
- Acronym
- DECOUVRIR-M
- Status last verified
- Jun 2019
- First submitted
- 25 Aug 2017
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35013789
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digestion: Building a Better Health and Better Understanding the Digestive Processes Thanks to Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03265392
- Acronym / sponsor ID
- DECOUVRIR-M / DECOUVRIR-M
- Conditions
- Glycemic Index, Gastric Emptying, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- IR4M (Imagerie par Résonance Magnétique Médicale et Multi-Modalités)
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Bread + Water | Other | Other: Bread, Other: WaterParticipants in this arm will randomly consume bread and 250 mL of water on 1 out of 3 visits of Part 1. |
| Part 1 - Bread + Lemon Juice | Other | Other: Bread, Other: Lemon juiceParticipants in this arm will randomly consume bread and 250 mL of lemon juice on 1 out of 3 visits of Part 1. |
| Part 1 - Bread + Tea | Other | Other: Bread, Other: TeaParticipants in this arm will randomly consume bread and 250 mL of tea on 1 out of 3 visits of Part 1. |
| Part 2 - Bread + water | Other | Other: Bread, Other: Water, Other: PeasParticipants 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. |
| Part 2 - Bread+ Lemon Juice | Other | Other: Bread, Other: Lemon juice, Other: PeasParticipants 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. |
| Part 2 - Bread+ tea | Other | Other: Bread, Other: Tea, Other: PeasParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (31 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreadServing of wheat bread providing 50 g of carbohydrates | Other | 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 |
| Water250 mL of water | Other | Part 1 - Bread + Water, Part 2 - Bread + water |
| Lemon juice250 mL of lemon juice | Other | Part 1 - Bread + Lemon Juice, Part 2 - Bread+ Lemon Juice |
| Tea250 mL of tea | Other | Part 1 - Bread + Tea, Part 2 - Bread+ tea |
| Peas20 peas | Other | Part 2 - Bread + water, Part 2 - Bread+ Lemon Juice, Part 2 - Bread+ tea |
Primary outcome
Energy intake (Main outcome of Part 1)
Time frame: 3 hours
Consumption at an ad libitum meal served 3 h after each test-meal during part 1
Gastric emptying (Main outcome of Part 2)
Time frame: 3 hours
Gastric empting kinetics of each test-meal, evaluated by MRI, during part 2
2 secondary outcomes
Glycemic Response (Secondary outcome of Parts 1 and 2)
Time frame: 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)
Time frame: At baseline and at different time-points during 3 hours after consuming the test meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Derived from this study: PubMed 35013789Freitas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Benamouzig, MD, PhD principal investigator
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bread, Water and Lemon juice in people with Glycemic Index and Gastric Emptying, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake (Main outcome of Part 1) (time frame: 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03265392, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.