Glycemic Response to Different Food Combinations

Postprandial Glycemia Clinical Trial

Official title:

Investigation of the Impact of Food Combination Strategies on Postprandial Blood Glucose Responses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05456672
• Other study ID #: GlucoMatchMaker
• Status: Completed
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: September 5, 2022

Study information

• Verified date: February 2023
• Source: Hospital de Santo Espírito
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the impact of combining starch rich foods with low pH foods on the glycemic response to meals

Description:

Low pH foods can attenuate the glycemic response to starch-rich foods. It has been demonstrated that lemon juice, due to its low pH (pH≈2.3) inhibited key digestive enzymes thereby interrupting gastric digestion of starch in vitro. This effect can significantly reduce the glycemic response in humans. In particular, adding lemon juice to a starch rich meal reduced the mean blood glucose concentration peak by 30%.

Considering the panoply of food options available, it is likely that other combinations have similar effects but no work has been conducted to develop a consolidated knowledge base to exploit this strategy. GlucoMatchMaker will go beyond the state-of-the art by addressing this knowledge gap. The main goal is to develop and test the real-life impact of pH-based food combination strategies on glycemic responses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 5, 2022
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subject has given written informed consent

• Subject is available to participate in the study sessions on the proposed dates.

Exclusion Criteria:

• Subject has an allergy or intolerance to any food and/or ingredient in the study meals

• Body mass index = 18.5 kg/m2 or = 30.0 kg/m2.

• Diagnosed mouth, throat or active gastrointestinal pathology that may affect normal ingestion and digestion of food.

• History of pancreatic disease

• Subject is immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year).

• Subject has Type 1 or Type 2 diabetes mellitus or pre-diabetes.

• Subject has a history of drug and/or alcohol abuse at the time of enrolment.

• Subject is currently taking medication that can effect glucose metabolism and/or normal gastrointestinal function.

• Subject is currently participating in another study, or plans to participate in another study during the study period.

• Women of child-bearing potential who do not use an acceptable method of contraception.

• Pregnant or nursing (lactating) women.

Related Conditions & MeSH terms

• Postprandial Glycemia

Intervention

Other:
• Test meals and food baskets
Interventional dietary study using standardized test meals and personalized food baskets to investigate the impact of food combination on the glycemic response. The study period is organized as follows: (Day 1: Continuous blood glucose monitoring system (CGM) activation) Days 2 and 3: Two standardized daily menus (breakfast, lunch, afternoon snack and dinner) provided on a randomized crossover basis. Days 4 to 7: four standardized test meals, participants will be asked to substitute one meal each day (lunch or dinner) for a test meal according to a pre-defined randomization plan. Days 8 to 10: Participants will be asked to prepare all meals using a food basket containing a mix of standardized and personal preference items. Days 11 to 13: Participants will be asked to prepare all meals using a food basket containing a mix of standardized and personal preference items and following dietary recommendations developed by the study staff. (Day 14: CGM sensor removed)

Locations

Country	Name	City	State
Portugal	Hospital de Santo Espírito da Ilha Terceira	Angra Do Heroísmo	Azores
Portugal	TERInov	Angra Do Heroísmo	Azores

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Santo Espírito	European Union

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic response	Measurement of postprandial glucose concentrations	12 days
Secondary	Composition of non standardized meals	Participants' food diaries	10 days
Secondary	Adherence to food combination recommendations	Based on participants' food diaries while using the food baskets provided on days 11 to 13	3 days
Secondary	Salivary alpha-amylase activity	Amylolytic activity of salivary alpha-amylase	Baseline
Secondary	AMY 1 copy number	Salivary amylase gene (AMY1) copy number	Baseline
Secondary	Dietary patterns	Food Frequency Questionnaire	Baseline