Recruiting

Observational Study

Sponsor:

University of the Pacific

Code:

NCT04102657

Conditions

Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Intermittent Fasting

Free-Living Diet

Left Arm Exercise

Right Arm Exercise

Study Details

Brief summary:

Interest in continuous glucose monitors (CGMs) is growing for use in evaluating real time glucose levels and in detecting extreme high and low values. A CGM is a small device primarily placed on the patient's upper arm or abdomen to measure glucose at frequent time intervals. While the accuracy of these devices is researched extensively, there are no large-scale studies evaluating the differences in the right and left arm in terms of device placement. In addition, intermittent fasting has gained popularity due to potential health benefits including reductions in weight, cholesterol, and blood glucose. However, there remains a shortage of studies researching the effect of short-term intermittent fasting on body fat.

The purpose of this study is to see if there is a difference between glucose levels in the right arm and left arm and to examine if short-term intermittent fasting may impact an individual's body fat percentage.

Conditions

Diabetes

Study ID

NCT04102657

Start date

Sep 20, 2019

Status verified date

Sep, 2019

Completion date

Nov, 2019

Anticipated

Primary completion date

Nov, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults 18-65 years of age
  • Willing to wear CGM device for 12-14 days on both arms
  • Have active health insurance
  • Willing to refrain from any heat therapy for the duration of the study
  • Having an interest to comply with the fasting requirements of the study as appropriate
  • Willingness to maintain once daily email responses

Exclusion Criteria:

  • Any active dermatologic condition on the upper arms
  • Implanted medical devices (i.e. pacemaker)
  • Critically ill or dialysis patients
  • Planned magnetic resonance imaging screening, computed tomography scan, x-ray imaging or high-frequency electrical heat treatment during study period
  • Current systemic infections
  • Subjects who are unable to fully understand the study or consent process will not be included in the study due to the lack of a qualified medical translator
  • Refusal to sign the informed consent document
  • Pregnant, planned-pregnancy in the next 30 days, or breast-feeding
  • Active eating disorder
  • Taking any medications that have an increased risk of hypoglycemia (e.g. sulfonylureas, insulin, thiazolidinediones) as determined by the primary investigators
  • Taking medications for obesity
  • You have one of the following medical conditions that can cause rapid weight loss: rheumatoid arthritis, hyperthyroidism, irritable bowel syndrome, cancer, HIV, active tuberculosis, Addison's disease
  • In an active weight loss program
  • On a specialized diet (e.g. Weight Watchers, ketogenic diet, Atkins diet)
  • Completed a specialized diet in the past 2 weeks (e.g. Weight Watchers, ketogenic diet, Atkins diet)
  • History of adverse events (i.e. shaking, dizziness, fatigue, fainting) during any prior fasting experience
  • Below the age of 18 years and above the age of 65 years

Study Design

Enrollment

46 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Intermittent Fasting with Left Arm Exercise

Healthy volunteers willing to fast for a 16-hour period daily for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily.

experimental: Intermittent Fasting with Right Arm Exercise

Healthy volunteers willing to fast for a 16-hour period daily for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily.

experimental: Free-living Diet with Left Arm Exercise

Healthy volunteers maintaining their current diet for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily.

experimental: Free-living Diet with Right Arm Exercise

Healthy volunteers maintaining their current diet for 12-14 days. Volunteers will also complete a 20-minute unilateral arm exercise daily.

Interventions

Intermittent Fasting

Participants will be instructed to limit their daily food consumption to an 8-hour period in the day of their choosing. For the 16-hour fasting period, subjects are to eliminate caloric intake.

Free-Living Diet

Participants will maintain their current daily food consumption with no caloric restriction. Patient must not have participated in a specialized diet or weight loss program within 2 weeks of enrollment.

Left Arm Exercise

Participants will complete a 20-minute period of rest followed by a 20-minute unilateral arm exercise on the left arm. In the middle of the study, participants will switch to the right arm to complete their unilateral arm exercises.

Right Arm Exercise

Participants will complete a 20-minute period of rest followed by a 20-minute unilateral arm exercise on the right arm. In the middle of the study, participants will switch to the left arm to complete their unilateral arm exercises.

Primary outcome measure

  • Difference in time-matched glucose levels between the right arm and left arm [ Time Frame: 12-14 days ]
  • Difference in body-fat percentage before and after 12-14 days of designated diet [ Time Frame: 12-14 days ]

Central Contacts and Locations

Central contacts

Essie Liu, PharmD

707-423-3277xliu2@pacific.edu

Sonoko Kawakatsu, PharmD

707-423-3277skawakatsu@pacific.edu

Locations

University of the Pacific

Recruiting

Stockton, California, United States, 95211

Contacts

Essie Liu, PharmD

707-423-3277xliu2@pacific.edu

Sonoko Kawakatsu, PharmD

7074233277skawakatsu@pacific.edu

More Information

Sponsor

University of the Pacific

Last update posted

Sep 25, 2019

Last verified

Sep, 2019

Keywords

  • CGM
  • Glucose Monitoring
  • Intermittent Fasting
  • Fasting
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of the Pacific on 2019-09-25.