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Glycemic Response to Different Food Combinations

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05456672
Enrollment
25
Registered
2022-07-13
Start date
2022-07-18
Completion date
2022-09-05
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postprandial Glycemia

Keywords

Digestion, Starch, Glycemic Index

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.

Interventions

OTHERTest 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)

Sponsors

European Union
CollaboratorOTHER
Hospital de Santo Espírito
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Glycemic response12 daysMeasurement of postprandial glucose concentrations

Secondary

MeasureTime frameDescription
Composition of non standardized meals10 daysParticipants' food diaries
Adherence to food combination recommendations3 daysBased on participants' food diaries while using the food baskets provided on days 11 to 13
Salivary alpha-amylase activityBaselineAmylolytic activity of salivary alpha-amylase
AMY 1 copy numberBaselineSalivary amylase gene (AMY1) copy number
Dietary patternsBaselineFood Frequency Questionnaire

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026