RECRUITING Not applicable ClinicalTrials.gov

Advancing Precision Nutrition: Wearable Technology for Noninvasive Insulin Monitoring

Sponsor: Texas A&M University • ClinicalTrials.gov ID: NCT07254364

Registry updated: 2026-10-05

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Description

Noninvasively monitoring insulin is crucial for advancing precision nutrition and promoting healthy living by enabling a deeper understanding of individual metabolic responses to dietary intake. Insulin is a key regulator of blood sugar and energy metabolism, and its dysregulation is linked to conditions such as diabetes, obesity, and metabolic syndrome. By noninvasively tracking insulin levels, individuals can gain real-time insights into how their body processes different foods, allowing for the personalization of diets to optimize metabolic health, manage weight, and reduce disease risk. This approach also empowers proactive lifestyle adjustments to maintain insulin sensitivity, improve glycemic control, and enhance overall well-being. Decentralized insulin quantification in biofluids, including saliva and serum, based on lateral flow assay or electrochemical sensor has been reported. However, these approaches have poor sensitivity and fail to quantify insulin with a high temporal resolution.

Interventions

Standardized meal 1 (Other)
Meal contains Whey powder (60g) as protein, Maltodextrin (Polycose; 170g) as carbohydrate, and Sunflower Oil (48g) as the fat source. The meal is mixed and flavored using vanilla sugar-free instant pudding.

Eligibility criteria

Inclusion criteria: * Age * ● 18-30 years old * ● 50-90 years old * BMI between 18 and 35 kg/m2 * Ability to walk, sit down, and stand up (independently or with a walking assistance device) * Willingness to lay supine in bed for up to 9 hours * Willingness and ability to comply with the protocol Exclusion criteria * Known allergy to any of the components of the meal or agents used for the application of the devices * Sunflower oil * Maltodextrin * Whey protein * Pilocarpine solutions * Established diagnosis and active treatment of chronic disease: insulin-dependent diabetes, active malignancy, heart failure, kidney disease, liver disease, HIV/AIDS, asthma (moderate to severe), Hep (A, B, or C) * History of untreated metabolic disease including hepatic or renal disorder * Presence of acute illness or metabolically unstable chronic illness * Active dependence on alcohol or drugs * Use of a short course of oral corticosteroids within 4 weeks preceding study day * Current use of long-term oral corticosteroids * Presence of fever within the last 3 days * Planned elective surgery requiring 2 or more days of hospitalization during the entire study * (Possible) pregnancy (confirmed via urine pregnancy test for females 18-30 years) * Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject * Any 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

Conditions

Insulin Response Type 1 Diabetes

Locations

Texas A&M University — College Station, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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