Macronutrient Distribution and Plasma Metabolites to Model Meals Composition

NCT04928872 | Completed

• 1 other identifier: 2017-0886
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous glucose monitors (CGMs) measure plasma glucose concentration continually and thus they are a key tool in the management of diabetes, including type 2 diabetes (T2D). A key factor in diabetes management is a reduction of dietary carbohydrates (CHO) and/or exchanging high glycemic index (GI) CHO with low GI CHO. However, the protein and fat content of the meal can have a significant impact on the glucose readings obtained from a CGM as there is no enough data available on their sensitivity during meals.

Conditions

Glucose Metabolism

Keywords

response to food; plasma glucose; continuous glucose monitor

Outcome Measures

Primary Outcomes (1)

• Prediction models of postprandial plasma amino acid patterns in relation to the macronutrient content of predefined meals as assessed by plasma concentrations of amino acids, glucose, and/or triglycerides

  Participants consume 9 predefined meals in the fasted state with macronutrient composition reflecting common meals in the US diet. One meal is consumed during one study visit with a total of 9 visits. A baseline sample is collected followed by an intake of one meal during one study visit. Blood samples (in the 15-and 30-minutes interval) are collected for 8 hours after a meal intake. Collected plasma will be used for amino acid analysis. Statistical models will be used to predict plasma amino acids from patterns of amino acids, glucose, and/or triglycerides in the consumed meals.

  9 study visits: one meal per one study day, 2-3 meals per week, 8-hour blood blood sample collection after a meal intake. Study completion: 4-5 weeks.

Secondary Outcomes (1)

• Discordance of glucose measurement after an intake of the predefined meal as measured by a fingerstick, continuous glucose monitor, and certified laboratory

  9 study visits: one meal per one study day, 2-3 meals per week, 8-hour blood blood sample collection after a meal intake. Study completion: 4-5 weeks.

Study Arms (1)

Non-diabetic older adults

Non-diabetic older adults

Combination Product: Predefined meal

Interventions

Predefined meal COMBINATION_PRODUCT

Nine predefined meals are administered in a randomized fashion, one meal per one study day, 2-3 study days per week. Meals have a form of drinks with different compositions of protein, carbohydrates and fat in relation to the US diet

Non-diabetic older adults

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy older adults (60-85y; equal gender) with a BMI between 25 and 35 will be recruited from an existing database of CTRAL. In addition, we will recruit older adults that respond to distributed flyers and advertisements in the newspaper and to radio announcements in the community of the College Station/Bryan area. Informed consent will be obtained on the screening day before any study-related procedures will be performed. If inclusion/exclusion criteria are met, subjects are invited to take part in the study.

You may qualify if:

• Ability to walk, sit down and stand up independently
• Ability to lie in a supine or slightly elevated position for 8.5 hours
• BMI between 25 and 35 kg/m2
• Willingness and ability to comply with the protocol

You may not qualify if:

• Established diagnosis of malignancy
• Established diagnosis of Insulin-Dependent Diabetes Mellitus
• History of untreated metabolic diseases including hepatic or renal disorder
• Presence of acute illness or metabolically unstable chronic illness
• Recent myocardial infarction (less than 1 year)
• Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
• Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements

Sponsors & Collaborators

• Texas A&M University: lead
• U.S. National Science Foundation: collaborator

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

Location

Related Publications (1)

• Barua S, A Wierzchowska-McNew R, Deutz NEP, Sabharwal A. Discordance between postprandial plasma glucose measurement and continuous glucose monitoring. Am J Clin Nutr. 2022 Oct 6;116(4):1059-1069. doi: 10.1093/ajcn/nqac181.

  PMID: 35776949 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

Study Officials

• Nicolaas EP Deutz, MD, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chancellor Edges Fellow

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 16, 2021
• Study Start: June 20, 2018
• Primary Completion: January 14, 2020
• Study Completion: January 14, 2020
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)