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Time-Restricted Eating for Breast Cancer Risk Reduction (TREC Trial)

N/A

Waitlist Available

Led By Harsha Karanchi, MD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

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

Must have

Age ≥ 40 and ≤ 67

Postmenopausal women with pre-diabetes (A1C 5.7-6.4% and/or fasting glucose 100-125 mg/dL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 1 and visit 2 approximately 12 weeks

Awards & highlights

TREC Trial Summary

This trial will test whether time restricted feeding, or eating within an 8-hour window, can improve health outcomes. There will be 2 groups, one that eats within an 8-hour window and one that doesn't, and various health outcomes will be measured. The study will last 3 1/2 months.

Who is the study for?

This trial is for postmenopausal women aged 40-67 with prediabetes, who own a smartphone. They must have an A1c level of 5.7-6.4% or fasting glucose of 100-125 mg/dL within the last year. Exclusions include active cancer, recent tobacco use, significant weight loss recently, strict dietary patterns like veganism, severe kidney disease, diabetes mellitus, extreme obesity (BMI≥40), heart disease history, certain medication usage including for diabetes and affecting metabolism or immune function.Check my eligibility

What is being tested?

The study tests time-restricted feeding where participants eat within an 8-hour window versus a control group with a ≥12-hour eating period over about three and a half months. It includes two in-person visits for biological sample collection and eight remote sessions with health professionals to support adherence to the eating schedule.See study design

What are the potential side effects?

Since this trial involves dietary changes rather than medication or medical procedures, side effects may be minimal but could include hunger outside of eating windows or potential changes in energy levels due to alterations in diet timing.

TREC Trial Eligibility Criteria

Inclusion Criteria

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

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I am between 40 and 67 years old.

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I am a postmenopausal woman with pre-diabetes.

TREC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1 and visit 2 approximately 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1 and visit 2 approximately 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 and visit 2 approximately 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Assess feasibility and adherence to time period of eating recommendations in both study groups.

Change in Advanced Glycation End Products (AGE) as assessed by plasma

Change in sRAGE(soluble receptor for AGE) levels

Secondary outcome measures

Adherence to time period of eating recommendation in both study groups: self reporting during virtual visits and through food photography / annotated entries.

Adherence to virtual visit with psychologist or dietician

Change in 24 hour urinary AGE levels

+6 more

TREC Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Time restricted feedingExperimental Treatment1 Intervention

daily eating period of 8 hours, before 8 PM

Group II: ControlActive Control1 Intervention

daily eating period ≥ 12 hours

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Time restricted feeding

2019

Completed Phase 2

~880

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

932 Previous Clinical Trials

7,394,231 Total Patients Enrolled

Harsha Karanchi, MDPrincipal InvestigatorMedical University of South Carolina

Media Library

Time restricted feeding Clinical Trial Eligibility Overview. Trial Name: NCT05038137 — N/A

Prediabetes Research Study Groups: Time restricted feeding, Control

Prediabetes Clinical Trial 2023: Time restricted feeding Highlights & Side Effects. Trial Name: NCT05038137 — N/A

Time restricted feeding 2023 Treatment Timeline for Medical Study. Trial Name: NCT05038137 — N/A

Frequently Asked Questions

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

What is the ambition of this clinical trial?

"The foremost purpose of this research, which is to be tracked for about 12 weeks over Visit 1 and Visit 2, will explore fluctuations in Advanced Glycation End Products (AGE) as observed through plasma. Secondary objectives consist of assessing the adherence rate with virtual visits to psychologists, measuring compliance with recommendations on eating times between study groups, and observing RAGE gene expression within peripheral blood mononuclear cells."

Answered by AI

How many individuals are currently taking part in this research initiative?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was first posted on May 4th 2022, is actively recruiting patients at the present time. Specifically, 44 individuals need to be enrolled from 1 specific site."

Answered by AI

Are there still opportunities for volunteers to join this clinical experiment?

"This clinical trial, first published on May 4th 2022, is actively enrolling patients as per information provided by clinicaltrials.gov and was last amended on September 19th 2022."

Answered by AI

Are minors within the age range of 25 and below eligible for participation in this research project?

"According to the stated criteria, enrolment into this clinical trial is limited to individuals between 40 and 60 years of age. The same website has 84 studies that are exclusively for minors and 2671 trials open solely for people over 65."

Answered by AI

Am I eligible to partake in this investigation?

"This trial is admitting 44 people with impaired glucose tolerance aged between 40 and 60. The prerequisites for enrolment are as follows: An age of at least 40 years old, but no more than 60; Postmenopausal women (no menstrual periods over the preceding 12 months) presenting with pre-diabetes (A1C 5.7-6.4% or fasting blood glucose 100-125 mg/dL); Lab results confirming A1c and/or fasting glucose must have been obtained within 12 months prior to signing consent form, ideally from a lab located on Medical University of South carolina's campus which can be verified through their electronic"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Time Restricted Eating on Cancer Risk

Harsha Karanchi, MD 2022. "Time Restricted Eating on Cancer Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05038137.

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