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Behavioural Intervention

Premenopausal women (lean and obese) for Obesity

N/A

Waitlist Available

Led By Stephanie T Chung, M.D.

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women between ages 18-50 years who are premenopausal (defined as regular menses and/or FSH <ULN)

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0, day 3

Awards & highlights

Study Summary

This trial will study how TRE affects women of different body sizes.

Who is the study for?

Healthy premenopausal women aged 18-50 with a BMI of either 18-24.9 or over 30, who are willing to follow the study's lifestyle guidelines and procedures for its duration. Exclusions include those with certain metabolic conditions, on specific medications affecting metabolism, heavy caffeine users, irregular sleep/eating patterns, recent weight fluctuations, competitive athletes, alcohol consumers exceeding three drinks daily, and tobacco/nicotine users.Check my eligibility

What is being tested?

The trial is examining how early time-restricted eating (TRE), where participants eat only during a limited part of the day compared to a conventional diet spread over 12 hours affects ketone metabolism and immune function in women. It includes tests like DXA scans and stable isotope tracer studies during a five-day clinic stay.See study design

What are the potential side effects?

Since this trial involves dietary interventions rather than medication or invasive procedures, side effects may be minimal but could include hunger outside of eating windows or changes in energy levels due to TRE.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman aged 18-50 and have regular periods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0, day 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0, day 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, day 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in CD4+ T cell responsiveness (Th17 polarization)

Change in ketone body (beta hydroxybutyrate) rate of appearance (Ra)

Secondary outcome measures

Change in CD4+ T cell responsiveness (Th17 polarization) in lean women vs women with obesity

Change in ketone body rate of appearance (Ra) in lean women vs women with obesity

Change in post-absorptive glucose rate of appearance (Ra)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Premenopausal women (lean and obese)Experimental Treatment2 Interventions

Ages 18-50 yearsBMI 18.0-24.5 mg/k^2 or BMI > 30 mg/k^2

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor

2,360 Previous Clinical Trials

4,314,702 Total Patients Enrolled

446 Trials studying Obesity

588,788 Patients Enrolled for Obesity

Stephanie T Chung, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4 Previous Clinical Trials

258 Total Patients Enrolled

2 Trials studying Obesity

228 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must be met to participate in this medical experiment?

"To be eligible for inclusion in this medical trial, prospective participants must have obesity and possess an age between 18 to 50 years of age. Approximately 150 candidates are needed."

Answered by AI

Is geriatric eligibility a factor in this experiment?

"To meet the requirements of this medical trial, applicants must be between 18 and 50 years old. On clinicaltrials.gov there are 204 trials for those under 18 and 678 for individuals over 65."

Answered by AI

Are participants currently being accepted for this clinical experiment?

"This research trial, which was first made public on February 5th 2024 and last modified on December 11st 2023, is no longer recruiting participants. However, at present there are 1,082 other clinical trials that are actively enrolling patients."

Answered by AI

What outcomes are expected to be achieved by this research endeavor?

"The principal endpoint of this investigation, calculated over 0 and 3 days, is the transformation in CD4+ T cell responsiveness (Th17 polarization). Additional targets comprise a comparison between lean women and those with obesity regarding changes in post-absorptive glucose rate of appearance ([6,6-2H2]glucose intravenously) after six hours of TRE as opposed to twelve hour eating window regimen; variance in CD4+ T cell response following 36 hours of TRE compared to extended feeding period likewise among slim versus overweight women; as well as difference concerning ketone body rate of presence after a similar 6hr/12h treatment contrast."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation

2024. "Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06169137.

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