Evaluation of Biomarkers for Predicting Macronutrient Intake

Обзор

The goal of this clinical trial is to establish the relationship between macronutrient food intake and the resulting blood and intersticial fluid (ISF )levels of small molecule markers, as well as, validate wearable optical readers and data fusion algorithms to accurately predict individual-specific macronutrient availability in real time. The study involves 1 screening visit of approximately 2 hours and up to 4 study days of approximately 14 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 visit, 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.

Подробное описание

On each study day, body weight and height will be measured. An in-dwelling 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 multiple times. 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 amino acids, fatty acids, glucose, insulin).

In the opposite limb, a commercially available microdialysis catheter will be placed in the forearm following standard operating procedures developed by the European Academy of Allergy \& Clinical Immunology Task Force on Skin Microdialysis. Dialysate will be collected in 30-minute aliquots in microvials for the duration of the study day. Microvials will be weighed before and after sample collection. A syringe filled with perfusate containing mixture of stable tracer-labelled amino acids and glucose will be infused through the syringe pump at a controlled rate.

On each of the study days, subjects will consume two meals with defined composition of macronutrients eight hours apart.

Вмешательства

• Другое Meal set A
  morning meal: low carbohydrate, low protein, low fat afternoon meal: high carbohydrate, high protein, high fat
• Другое Meal set B
  morning meal: low carbohydrate, high protien, low fat meal afternoon meal: high carbohydrate, low protein, high fat meal
• Другое Meal set C
  morning meal: low carbohydrate, low protien, low fat meal afternoon meal: high carbohydrate, high protein, low fat meal
• Другое Meal set D
  morning meal: high carbohydrate, low protien, low fat meal afternoon meal: low carbohydrate, high protein, high fat meal

Первичные конечные точки

• Glucose metabolism [Срок оценки: Up to 14 hours per study visit, up to 4 visits]

Вторичные конечные точки (1)

• Amino acid metabolism [Срок оценки: Up to 14 hours per study visit, up to 4 visits]

Критерии участия

Критерии включения

• Ability to walk, sit down and stand up independently
• Age 50-75 years old
• Ability to lie in supine or slightly elevated position for approximately 13 hours
• BMI between 25 and 35
• Willingness and ability to comply with the protocol

Критерии исключения

• Established diagnosis of malignancy
• Established diagnosis of Insulin or non-Insulin Dependent Diabetes Mellitus
• History of untreated metabolic diseases including hepatic or renal disorder
• Currently on anticoagulants (i.e., warfarin, factor X inhibitors or direct thrombin inhibitors)
• History of deep vein thrombosis, pulmonary embolisms, or known clotting disorders
• Presence of acute illness or metabolically unstable chronic illness
• Recent myocardial infarction (less than 1 year)
• Known allergy or intolerance to any of the meal components
• 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 participant to comply with the protocol requirements

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Center for Translational Research in Aging & Longevity — College Station

Идентификаторы

NCT: NCT06582381 · 91-Micro2 · R01DK136414

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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