NCT05139264

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

November 18, 2021

Last Update Submit

September 18, 2023

Conditions

Metabolism Disorder, Glucose

Outcome Measures

Primary Outcomes (1)

  • Glucose

    Mean, fasting, post-prandial measured by continuous glucose monitoring

    2 weeks

Secondary Outcomes (3)

  • Sleep duration

    2 weeks

  • Sleep fragmentation

    2 weeks

  • Diet composition

    2 weeks

Interventions

ObservationalOTHER

Observation of diet, physical activity, sleep and interstitial glucose

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult men and women willing to record food intake with their smartphone, complete online questionnaires, and wear body sensors to measure physical activity, sleep, and glucose.

You may qualify if:

  • Age: 18-75 y old
  • In possession of a smartphone
  • English speaking
  • Live in New York City metro area

You may not qualify if:

  • Active food intake disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Russ Berrie Medical Science Pavilion

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Blandine Laferrere, MD, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 18, 2021

First Posted

December 1, 2021

Study Start

May 3, 2021

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

US(1)