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Completed

NCT Number: NCT05456672

Glycemic Response to Different Food Combinations

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Santo Espírito da Ilha Terceira, Angra do Heroísmo, Azores, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test meals and food baskets

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)

Primary outcomes

  1. Glycemic response

    Time frame: 12 days

    Measurement of postprandial glucose concentrations

Secondary outcomes

  1. Composition of non standardized meals

    Time frame: 10 days

    Participants' food diaries

  2. Adherence to food combination recommendations

    Time frame: 3 days

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

  3. Salivary alpha-amylase activity

    Time frame: Baseline

    Amylolytic activity of salivary alpha-amylase

  4. AMY 1 copy number

    Time frame: Baseline

    Salivary amylase gene (AMY1) copy number

  5. Dietary patterns

    Time frame: Baseline

    Food Frequency Questionnaire

Sponsors and collaborators

Lead sponsor

Hospital de Santo Espírito

Other

Collaborators

  • European Union

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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