Clinical trial NCT05456672: Glycemic Response to Different Food Combinations
Official title: Investigation of the Impact of Food Combination Strategies on Postprandial Blood Glucose Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Glycemia
Keywords: Digestion
Starch
Glycemic Index
Lead sponsor: Hospital de Santo Espírito
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2022-07-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glycemic response
timeFrame: 12 days
Secondary outcomes:
measure: Composition of non standardized meals
timeFrame: 10 days
measure: Adherence to food combination recommendations
timeFrame: 3 days
measure: Salivary alpha-amylase activity
timeFrame: Baseline
measure: AMY 1 copy number
timeFrame: Baseline
measure: Dietary patterns
timeFrame: Baseline
Other outcomes:
Locations:
city: Angra Do Heroísmo
country: Portugal
facility: Hospital de Santo Espírito da Ilha Terceira
state: Azores
city: Angra Do Heroísmo
country: Portugal
facility: TERInov
state: Azores
Study officials:
References: