CClinicalTrials.gg
CompletedNCT05456672Updated Feb 8, 2023

Glycemic Response to Different Food Combinations

An interventional study of Test meals and food baskets in Postprandial Glycemia, sponsored by Hospital de Santo Espírito. Completed at 2 sites in Portugal. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Hospital de Santo Espírito · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Postprandial Glycemia

Keywords

  • Digestion
  • Starch
  • Glycemic Index
03

In context

Lead sponsor

This is the only study on the registry with Hospital de Santo Espírito as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Dietary intervention

    Dietary intervention using standardized test meals

    Other: Test meals and food baskets

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)

06

What researchers measure

Primary outcomes

  1. Glycemic response

    Measurement of postprandial glucose concentrations

    Time frame: 12 days

Secondary outcomes

  1. Composition of non standardized meals

    Participants' food diaries

    Time frame: 10 days

  2. Adherence to food combination recommendations

    Based on participants' food diaries while using the food baskets provided on days 11 to 13

    Time frame: 3 days

  3. Salivary alpha-amylase activity

    Amylolytic activity of salivary alpha-amylase

    Time frame: Baseline

  4. AMY 1 copy number

    Salivary amylase gene (AMY1) copy number

    Time frame: Baseline

  5. Dietary patterns

    Food Frequency Questionnaire

    Time frame: Baseline

07

Study locations

2 sites
  • Hospital de Santo Espírito da Ilha Terceira
    Angra Do Heroísmo, Azores 9700-049, Portugal
  • TERInov
    Angra Do Heroísmo, Azores 9700-702, Portugal
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05456672
Lead sponsor
Hospital de Santo Espírito
Collaborators
European Union
Responsible party
Daniela Freitas (Dr, Hospital de Santo Espírito) — Principal investigator
First posted
Jul 13, 2022
Start date
Jul 18, 2022
Primary completion
Sep 5, 2022
Completion
Sep 5, 2022
Last update
Feb 8, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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