Advancing Precision Nutrition: Wearable Technology for Noninvasive Insulin Monitoring

NCT07254364 | Recruiting

• 1 other identifier: 105-Sweat
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insulin Response

Outcome Measures

Primary Outcomes (1)

• Quantification of protein biomarkers

  Time-varying plasma insulin concentrations and correlation between sweat and dermal interstitial fluid.

  up to 9 hours, 1 day

Study Arms (1)

Standardized liquid meal drink

EXPERIMENTAL

We will provide a standardized drink consisting of whey, maltodextrin and sunflower oil, flavored using vanilla sugar-free instant pudding.

Other: Standardized meal

Interventions

Standardized meal OTHER

We will use 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.

Standardized liquid meal drink

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age
• years old
• years old
• BMI between 22 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

RECRUITING

Central Study Contacts

Nicolaas Deutz

CONTACT

979-458-1484; nep.deutz@ctral.org

Laura Ruebush

CONTACT

979-458-1484; le.ruebush@ctral.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Individual response to a standardized liquid nutrition meal.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)