Glycemic Response to Different Food Combinations

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

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

Study Overview

• Status: Completed
• Conditions: Postprandial Glycemia
• Intervention / Treatment: Other: Test meals and food baskets

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Azores
    • Angra Do Heroísmo, Azores, Portugal, 9700-049
      • Hospital de Santo Espírito da Ilha Terceira
    • Angra Do Heroísmo, Azores, Portugal, 9700-702
      • TERInov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Dietary intervention; Dietary intervention using standardized test meals

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic response	Measurement of postprandial glucose concentrations	12 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital de Santo Espírito
• Collaborators: European Union

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 18, 2022
• Primary Completion (ACTUAL): September 5, 2022
• Study Completion (ACTUAL): September 5, 2022

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (ACTUAL): July 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Glycemic Index; Starch; Digestion
• Other Study ID Numbers: GlucoMatchMaker

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No