Postprandial GlycemiaNCT05456672
Glycemic Response to Different Food Combinations
A study testing Test meals and food baskets in people with Postprandial Glycemia, run by Hospital de Santo Espírito at 2 sites in Portugal.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glycemia
- What is being tested?
- Test meals and food baskets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesPortugal
- Study dates
- 18 Jul 2022to 5 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has given written informed consent
- Subject is available to participate in the study sessions on the proposed dates.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Hospital de Santo Espírito da Ilha Terceira
Angra do Heroísmo, Azores, 9700-049
TERInov
Angra do Heroísmo, Azores, 9700-702
About this study
Official title: 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
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.
- Conditions
- Postprandial Glycemia
- Being tested
- Test meals and food baskets
- Keywords
- Digestion, Starch, Glycemic Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test meals and food basketsOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | Dietary intervention using standardized test meals Receives: Other: Test meals and food baskets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic response
Measurement of postprandial glucose concentrations
Measured: 12 days
Secondary outcomes (5)
Composition of non standardized meals
Participants' food diaries
Measured: 10 days
Adherence to food combination recommendations
Based on participants' food diaries while using the food baskets provided on days 11 to 13
Measured: 3 days
Salivary alpha-amylase activity
Amylolytic activity of salivary alpha-amylase
Measured: Baseline
AMY 1 copy number
Salivary amylase gene (AMY1) copy number
Measured: Baseline
Dietary patterns
Food Frequency Questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start18 Jul 2022
- Primary completion5 Sep 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial GlycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Santo Espírito
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Principal investigator, Daniela Freitas, Hospital de Santo Espírito
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456672
- Sponsor's protocol ID
- GlucoMatchMaker
- Status last verified
- Feb 2023
- First submitted
- 7 Jul 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Impact of Food Combination Strategies on Postprandial Blood Glucose Responses
- ClinicalTrials.gov ID
- NCT05456672
- Acronym / sponsor ID
- GlucoMatchMaker
- Conditions
- Postprandial Glycemia
- Keywords
- Digestion, Starch, Glycemic Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospital de Santo EspíritoUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Other: Test meals and food basketsDietary intervention using standardized test meals |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has given written informed consent
- Subject is available to participate in the study sessions on the proposed dates.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test meals and food basketsInterventional 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) | Other | Dietary intervention |
Primary outcome
Glycemic response
Time frame: 12 days
Measurement of postprandial glucose concentrations
5 secondary outcomes
Composition of non standardized meals
Time frame: 10 days
Adherence to food combination recommendations
Time frame: 3 days
Salivary alpha-amylase activity
Time frame: Baseline
AMY 1 copy number
Time frame: Baseline
Dietary patterns
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test meals and food baskets in people with Postprandial Glycemia, run by Hospital de Santo Espírito at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic response (time frame: 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.