Macronutrient Distribution and Plasma Metabolites to Model Meals Composition

NCT ID: NCT04928872

Last Updated: 2022-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-20
• Study Completion Date: 2020-01-14

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.

Detailed Description

The study involves 1 screening visit of approximately 1 hour and 9 study days of approximately 8 hours. Subjects will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening day, body weight, height, and body composition by Dual-energy X-ray absorptiometry (DXA) will be measured. In addition, habitual dietary intake, physical activity level (PASE), and quality of life (SGRQ-C) will be assessed.

To test the relation between plasma amino acid, triglycerides, and glucose concentration measured by standard methods (such as finger stick) and continuous wearable devices, a premarket FDA-approved continuous glucose monitor (CGM) from Abbott (FreeStyle Libre Pro) that monitors glucose concentrations every 15 min is used. The single-use sensors are placed on the upper arm and contain a very tiny 5 mm filament (<0.4 mm diameter) that is introduced into the skin when the sensor is placed. On the first study day, the CGM will be placed to monitor glucose concentrations until the last study day. At least every 14 days, sensors will be replaced by new ones. On each study day, body weight and height will be measured and the glucose concentration data will be downloaded from the sensor onto the reader device. A catheter will be inserted in a peripheral vein of the lower arm or hand to enable blood sampling. The arm will be put in a hot box to allow collecting arterialized venous blood samples. After taking a baseline blood sample, the predefined meal will be consumed within 10 min. Small arterialized venous blood samples (5 ml) will subsequently be drawn at times: 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, and 480 minutes (13 blood samples, total blood approx 65 ml). Samples will be collected in predefined tubes, plasma/serum separated, aliquoted, and stored at -80 deg. Celsius for later assays and/or send to a local accredited laboratory for the concentrations of amino acids and other parameters (including fatty acids, glucose, insulin).

Conditions

Glucose Metabolism

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-diabetic older adults

Non-diabetic older adults

Predefined meal

Intervention Type: 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

Interventions

Predefined meal

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. National Science Foundation

FED

Sponsor Role: collaborator

Texas A&M University

OTHER

Sponsor Role: lead

Responsible Party

Marielle PKJ Engelen, PhD

Professor & Chancellor Edges Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicolaas EP Deutz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Locations

Texas A&M University

College Station, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35776949 (View on PubMed)

Other Identifiers

2017-0886

Identifier Type: -

Identifier Source: org_study_id