Glycemic Response to Different Food Combinations

Not Applicable

Completed

• Conditions: Postprandial Glycemia
• Interventions: Other: Test meals and food baskets

• Registration Number: NCT05456672
• Lead Sponsor: Hospital de Santo Espírito

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.

Study Timeline

• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-13
• Study Start: 2022-07-18
• Primary Completion: 2022-09-05
• Study Completion: 2022-09-05
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dietary intervention	Test meals and food baskets	Dietary intervention using standardized test meals

Primary Outcome Measures

Name	Time	Method
Glycemic response	12 days	Measurement of postprandial glucose concentrations

Secondary Outcome Measures

Name	Time	Method
AMY 1 copy number	Baseline	Salivary amylase gene (AMY1) copy number
Adherence to food combination recommendations	3 days	Based on participants' food diaries while using the food baskets provided on days 11 to 13
Dietary patterns	Baseline	Food Frequency Questionnaire
Salivary alpha-amylase activity	Baseline	Amylolytic activity of salivary alpha-amylase
Composition of non standardized meals	10 days	Participants' food diaries

Trial Locations

Locations (2)

TERInov; 🇵🇹 Angra Do Heroísmo, Azores, Portugal

Hospital de Santo Espírito da Ilha Terceira; 🇵🇹 Angra Do Heroísmo, Azores, Portugal