An interventional study of Bread and Water in Glycemic Index, Gastric Emptying and Appetite, sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement. Completed at 1 site in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-07.
Sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Not applicable, Interventional, and Basic science
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.
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.
Inclusion Criteria:
Additional criteria for Part 2
Non-inclusion criteria:
Additional exclusion criteria for Part 2:
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
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
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
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
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
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
Serving of wheat bread providing 50 g of carbohydrates
250 mL of water
250 mL of lemon juice
250 mL of tea
20 peas
Energy intake (Main outcome of Part 1)
Consumption at an ad libitum meal served 3 h after each test-meal during part 1
Time frame: 3 hours
Gastric emptying (Main outcome of Part 2)
Gastric empting kinetics of each test-meal, evaluated by MRI, during part 2
Time frame: 3 hours
Glycemic Response (Secondary outcome of Parts 1 and 2)
Capillary blood glucose monitoring
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)
Evaluation of satiety, fullness, hunger, prospective food consumption and desire to eat through visual analogue scales (VAS)
Time frame: At baseline and at different time-points during 3 hours after consuming the test meal
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)
Time frame: 12-16 hours after the test meal (Part 1 and 2)
Gastric contractions
Analysis of MRI scans will be carried out to evaluate the frequency of gastric contractions.
Time frame: At baseline and during 3 hours after after consuming the test meal (Part 2 only)
Amylolytic activity of saliva
The amylolytic activity of saliva samples collected before the test meal will be determined.
Time frame: At baseline (Part 1)
Plan to share: No
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Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement