Dietary Impact on Continuous Glucose Monitoring

NCT05845827 | Completed DMC

• 1 other identifier: STUDY02001962
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glucose Metabolism Disorders; Dietary Habits; Pediatric ALL; Adult ALL

Outcome Measures

Primary Outcomes (3)

• Number of dietary records completed by each study participant

  The researchers will measure dietary intake using a mobile phone application called BiteSnap. The goal is to have participants report \>90% of their meals using mobile phone photos to extract nutrient information.

  7-10 days

• Number of days wearing the continuous glucose monitor

  The researchers will measure the amount of time each participant wears the continuous glucose monitor. The goal is to have participants wear the monitor for \>90% of the time in the study.

  7-10 days

• Completion of the at-home glucose tolerance test

  Participants will be asked to drink a 75-gram glucose tolerance test. The researchers will measure the number of participants that self-reported drinking the shake at fasting. The goal will be 90% of participants self-report drinking the shake at fasting.

  7-10 days

Secondary Outcomes (2)

• Identify nutrients associated with an elevated glucose response, measured by the continuous glucose monitor.

  7-10 days

• Access the relationship between fitness levels and glucose response to standard of care meal tests.

  7-10 days

Eligibility Criteria

• Age: 14 Years - 22 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents and young adults, ages 14-22 years

You may qualify if:

• Adolescents and young adults, ages 14-22 years

You may not qualify if:

• Previous diagnosis of type 1 or 2 diabetes
• Previous diagnosis of hyperlipidemia or other metabolic disease
• Use of medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin).
• Allergies to milk.
• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• Ge M, Lebby SR, Chowkwale S, Harrison C, Palmer GM, Loud KJ, Gilbert-Diamond D, Vajravelu ME, Meijer JL. Impact of Dietary Intake and Cardiorespiratory Fitness on Glycemic Variability in Adolescents: An Observational Study. Curr Dev Nutr. 2025 Jan 21;9(2):104547. doi: 10.1016/j.cdnut.2025.104547. eCollection 2025 Feb.

  PMID: 39996052 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and buffy coat will be extracted from one blood sample (10mL).

MeSH Terms

Conditions

Glucose Metabolism Disorders; Feeding Behavior; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior, Animal; Behavior; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 6, 2023
• Study Start: June 20, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)