NCT05845827Completed
Dietary Impact on Continuous Glucose Monitoring
Impact of Dietary Intake on Continuous Glucose Patterns Considering Cardiorespiratory Fitness Levels.
Source: ClinicalTrials.gov · Last updated 29 Feb 2024
Brief summary (registry, in English)
Cardiorespiratory fitness (CRF), also known as "exercise capacity", is the capacity of respiratory and circulatory systems to supply oxygen to skeletal muscle during exercise for the generation of energy. Determinants of CRF include lung capacity, capillary density, cardiac output, hemoglobin concentration, and mitochondrial function. The research group studies how CRF is related to fuel utilization, yielding a mechanistic understanding of the association between lower CRF and worsening metabolic health via mitochondrial function. The objective of this study is to measure fuel utilization in response to habitual diet for one week in adolescents and young adults, ages 14-22 years (n=30). Fuel utilization will be estimated by glucose measures using a continuous glucose monitor (CGM). Habitual dietary intake will be collected via a mobile phone application (BiteAI, Inc) that uses artificial intelligence to extract nutrient information from food photographs. Participants will undergo two standard of care (SOC) meal tolerance tests at home - a glucose tolerance test and a Ensure® mixed meal tolerance test. CRF will be estimated by measuring maximum oxygen consumption (VO2 max) during a graded treadmill test. The hypothesis is that a higher VO2 max will be associated with increased fuel utilization, measured by lower glucose response to the SOC meal tolerance tests. The proposed study is described in the following aims: SPECIFIC AIM 1. Test for feasibility of completion of self-report dietary food records, completion of two at home meal tolerance tests that are standard of care for metabolic health screening, and completion of a seven-day continuous glucose monitor. SPECIFIC AIM 2. Identify nutrients and foods that are associated with an elevated glucose response. SPECIFIC AIM 3. Assess the influence of VO2 max on the glucose response to the SOC glucose tolerance test and Ensure® mixed meal tolerance test.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 30 (actual)
- First submitted
- 14 Apr 2023
- Start date
- 20 Jun 2023
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- NCT number
- NCT05845827
What you commit to
- Study type: Observational
- Participants enrolled: 30
- From 20 Jun 2023 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of type 1 or 2 diabetes
- Previous diagnosis of hyperlipidemia or other metabolic disease
Other illness
- Allergies to milk.
Lab values
- Use of medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin).
Other
- Inability to participant in the maximal exercise test on the treadmill.
- Individuals not having android or IOS phones
- Individuals who cannot speak and/or write in English.
Who the study is looking for
- Adolescents and young adults, ages 14-22 years
Age in the registry: 14 years to 22 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.