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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05139264
Other study ID # AAAT6779
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 3, 2021
Est. completion date February 1, 2022

Study information

Verified date September 2023
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

GLADS is a cross-sectional, observational study assessing free-living diet, physical activity, sleep, and glucose profile over a 2-week period in healthy adult men and women.


Description:

Monitoring free-living lifestyle behaviors can provide important information on behavioral determinants of health. New technologies have improved accessibility of ambulatory assessment of diet, biomarkers, physical activity, and sleep. The study will assess the effects of free-living diet assessed by questionnaire and sleep and physical activity measured by actigraphy on interstitial glucose measured by continuous glucose monitoring in healthy adult men and women over a 2-week period.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date February 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Age: 18-75 y old - In possession of a smartphone - English speaking - Live in New York City metro area Exclusion Criteria: - Active food intake disorder

Study Design


Intervention

Other:
Observational
Observation of diet, physical activity, sleep and interstitial glucose

Locations

Country Name City State
United States Russ Berrie Medical Science Pavilion New York New York

Sponsors (1)

Lead Sponsor Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose Mean, fasting, post-prandial measured by continuous glucose monitoring 2 weeks
Secondary Sleep duration Measured by actigraphy 2 weeks
Secondary Sleep fragmentation Measured by actigraphy 2 weeks
Secondary Diet composition Carbohydrates, fats, proteins assessed by dietary recall 2 weeks
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