Glycemic Response to Different Food Combinations

NCT ID: NCT05456672

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2022-09-05

Brief 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

Detailed 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.

Conditions

Postprandial Glycemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Dietary intervention

Dietary intervention using standardized test meals

Group Type: EXPERIMENTAL

Test meals and food baskets

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European Union

OTHER

Sponsor Role: collaborator

Hospital de Santo Espírito

OTHER

Sponsor Role: lead

Responsible Party

Daniela Freitas

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital de Santo Espírito da Ilha Terceira

Angra do Heroísmo, Azores, Portugal

TERInov

Angra do Heroísmo, Azores, Portugal

Countries

Portugal

Other Identifiers

GlucoMatchMaker

Identifier Type: -

Identifier Source: org_study_id