Pre-diabetesTRECNCT05038137
Time Restricted Eating on Cancer Risk
A study testing Time restricted feeding in people with Pre-diabetes and Breast Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Participants will be randomly assigned to either the time restricted feeding group with a daily eating period of 8 hours or the control group with a daily eating period of greater than or equal to 12 hours. Read more about this study
- Who is it for?
- Ages 40 to 67 years, women only
- Conditions the study is for
- Pre-diabetes, Breast Cancer, Time Restricted Feeding
- What is being tested?
- Time restricted feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2022to 23 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 67 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 and ≤ 67;
- Postmenopausal women (no menstrual periods in the preceding 12 or more months) with pre-diabetes (A1C 5.7-6.4% and/or fasting glucose 100-125 mg/dL). A1c lab and/or fasting glucose criteria will need to be met within 12 months of signing consent form, can be obtained from prior lab result or study prescreening testing;
- Own a smart phone with internet connection and capable of receiving and sending text messages and taking photographs;
Who cannot join
- Tobacco use (current or within last 2 years);
- Active malignancy or history of cancer;
- History of known liver disease (by serology: aspartate aminotransferase or alanine aminotransferase ≥ 3 times above upper limit of normal determined by lab review, imaging or biopsy: determined by patient history);
- History of kidney disease (patient history and/or estimated glomerular filtration rate less than 45 mL/min/1.73m²);
- History of diabetes mellitus:
- History of cardiovascular disease (MI, CHF);
Show all 15Show fewer
- Current prescription medication use for diabetes;
- Medication affecting glucose metabolism or appetite or immunosuppression;
- Dietary restrictions: currently following vegetarian or vegan dietary pattern;
- Currently following intermittent fasting or time restricted feeding pattern or use in the last 3 months;
- Night shift worker (work schedule does not involve any period of work from 10 PM to 5 AM either on a regular or rotating basis);
- History of weight loss >5% in the last 3 months;
- History of weight loss surgery.
- BMI≥40 kg/m² exclusion;
- After informed consent and run in period: Insufficient documented food photography/annotated entries (does not log at least two entries a day for 10 of 14 days) during run in period will be excluded from randomization in to the intervention period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: The Effects of Time Restricted Feeding on AGE-RAGE Signaling in Women at High Risk for Breast Cancer
Participants will be randomly assigned to either the time restricted feeding group with a daily eating period of 8 hours or the control group with a daily eating period of greater than or equal to 12 hours. There are 2 in-person study visits to have blood, urine and vital signs collected and 8 remote or phone visits with a psychologist or dietician to assist with the eating schedule. The study will take last 3 1/2 months.
- Conditions
- Pre-diabetes, Breast Cancer, Time Restricted Feeding
- Being tested
- Time restricted feeding, Control
- Medical subject headings
- Glucose Intolerance, Breast Neoplasms, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted feedingBehavioural
Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
ControlBehavioural
Participants will have a daily eating period equal to or greater than 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Time restricted feeding | Experimental | daily eating period of 8 hours, before 8 PM for 12 weeks Receives: Behavioral: Time restricted feeding |
| Control | Active comparator | daily eating period ≥ 12 hours for 12 weeks Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Advanced Glycation End Products (AGE) as Assessed by Plasma
Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated via 95% confidence intervals within and between groups.
Measured: Visit 1 (0 weeks), Visit 2 (14 weeks)
Change in sRAGE(Soluble Receptor for AGE) Levels
Estimated mean levels within the intervention and the control groups of the study. Effect size will estimated via 95% confidence intervals within and between groups.
Measured: Visit 1 (0 weeks), Visit 2 (14 weeks)
Assess Feasibility and Adherence to Time Period of Eating Recommendations in Both Study Groups.
Percentage of dietary visits that participant reported compliance with randomized eating period.
Measured: Visit 1 (0 weeks), Visit 2 (14 weeks)
Secondary outcomes (10)
Change in Fasting Insulin-like Growth Factor-1 (IGF-1) Levels
Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated via 95% confidence intervals within and between groups.
Measured: Visit 1 (0 weeks), Visit 2 (14 weeks)
Change in Fasting Insulin Levels
Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated via 95% confidence intervals within and between groups.
Measured: Visit 1 (0 weeks), Visit 2 (14 weeks)
Difference in Glasgow Prognostic Scoring System
The Glasgow Prognostic Score (GPS) reflects systemic inflammatory process. GPS is a three-tiered score [0: normal C-reactive protein (CRP) and albumin; 1: one abnormal result; 2: increased CRP and low albumin]. Higher score means worse outcome.
Measured: Visit 1 (0 weeks), Visit 2 (14 weeks)
Change in 24 Hour Urinary AGE Levels
Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated by the 95% confidence intervals within and between groups.
Measured: Visit 1 (0 weeks), Visit 2 (14 weeks)
Adherence to Virtual Visit With Psychologist or Dietician
Percentage of expected visits attended.
Measured: Visit 1 (0 weeks), Visit 2 (14 weeks)
Adherence to Time Period of Eating Recommendation in Both Study Groups: Self Reporting During Virtual Visits and Through Food Photography / Annotated Entries.
Proportion of dietary visits where participants reported compliance with randomized eating period, assessed through self-report during virtual visits and via food photography/annotated entries.
Measured: Visit 1 (0 weeks), Visit 2 (14 weeks)
Percentage of Participants With Stable Chronotype Between Baseline and End of Study
Stability in chronotype (normal, delayed, or advanced) was assessed using 2-week sleep diaries at baseline and end of study. Stability was defined as no change in chronotype classification between Visit 1 and Visit 2.
Measured: Visit 1 (0 weeks), Visit 2 (14 weeks)
Mean Glucose at Visit 2
Mean glucose level calculated as the average of continuous glucose monitoring (CGM) data collected during the final 14 days of the intervention period (Visit 2).
Measured: Final 14 days of intervention period (Visit 2).
Glucose Management Indicator (GMI) at Visit 2
GMI percentage derived from CGM data collected during the final 14 days of the intervention period (Visit 2).
Measured: Visit 2 (14 weeks)
Glucose Variability at Visit 2
Coefficient of variation of glucose levels derived from CGM data during the final 14 days of the intervention period (Visit 2).
Measured: Visit 2 (14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start4 May 2022
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Visit 1 at 0 weeks, followed by 2 week run-in and then randomization. Visit 2 at 14 weeks.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harsha Karanchi, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038137
- Sponsor's protocol ID
- 109489
- Acronym
- TREC
- Status last verified
- May 2026
- First submitted
- 31 Aug 2021
- Last updated
- 2 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Time Restricted Feeding on AGE-RAGE Signaling in Women at High Risk for Breast Cancer
- ClinicalTrials.gov ID
- NCT05038137
- Acronym / sponsor ID
- TREC / 109489
- Conditions
- Pre-diabetes, Breast Cancer, Time Restricted Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Posted 4 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will be randomly assigned to either the time restricted feeding group with a daily eating period of 8 hours or the control group with a daily eating period of greater than or equal to 12 hours. There are 2 in-person study visits to have blood, urine and vital signs collected and 8 remote or phone visits with a psychologist or dietician to assist with the eating schedule. The study will take last 3 1/2 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Visit 1 at 0 weeks, followed by 2 week run-in and then randomization. Visit 2 at 14 weeks.
| Arm | Type | Receives |
|---|---|---|
| Time restricted feeding | Experimental | Behavioral: Time restricted feedingdaily eating period of 8 hours, before 8 PM for 12 weeks |
| Control | Active comparator | Behavioral: Controldaily eating period ≥ 12 hours for 12 weeks |
Who may qualify
- Ages
- 40 to 67 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 40 and ≤ 67;
- Postmenopausal women (no menstrual periods in the preceding 12 or more months) with pre-diabetes (A1C 5.7-6.4% and/or fasting glucose 100-125 mg/dL). A1c lab and/or fasting glucose criteria will need to be met within 12 months of signing consent form, can be obtained from prior lab result or study prescreening testing;
- Own a smart phone with internet connection and capable of receiving and sending text messages and taking photographs;
Key exclusion criteria (15 listed)
- Tobacco use (current or within last 2 years);
- Active malignancy or history of cancer;
- History of known liver disease (by serology: aspartate aminotransferase or alanine aminotransferase ≥ 3 times above upper limit of normal determined by lab review, imaging or biopsy: determined by patient history);
- History of kidney disease (patient history and/or estimated glomerular filtration rate less than 45 mL/min/1.73m²);
- History of diabetes mellitus:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted feedingParticipants will eat all food during a self selected 8 hour eating window prior to 8:00 PM. | Behavioural | Time restricted feeding |
| ControlParticipants will have a daily eating period equal to or greater than 12 hours. | Behavioural | Control |
Primary outcome
Change in Advanced Glycation End Products (AGE) as Assessed by Plasma
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated via 95% confidence intervals within and between groups.
Change in sRAGE(Soluble Receptor for AGE) Levels
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Estimated mean levels within the intervention and the control groups of the study. Effect size will estimated via 95% confidence intervals within and between groups.
Assess Feasibility and Adherence to Time Period of Eating Recommendations in Both Study Groups.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Percentage of dietary visits that participant reported compliance with randomized eating period.
10 secondary outcomes
Change in Fasting Insulin-like Growth Factor-1 (IGF-1) Levels
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Change in Fasting Insulin Levels
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Difference in Glasgow Prognostic Scoring System
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Change in 24 Hour Urinary AGE Levels
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Adherence to Virtual Visit With Psychologist or Dietician
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Adherence to Time Period of Eating Recommendation in Both Study Groups: Self Reporting During Virtual Visits and Through Food Photography / Annotated Entries.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Percentage of Participants With Stable Chronotype Between Baseline and End of Study
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Mean Glucose at Visit 2
Time frame: Final 14 days of intervention period (Visit 2).
Glucose Management Indicator (GMI) at Visit 2
Time frame: Visit 2 (14 weeks)
Glucose Variability at Visit 2
Time frame: Visit 2 (14 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harsha Karanchi, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted feeding in people with Pre-diabetes and Breast Cancer, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Advanced Glycation End Products (AGE) as Assessed by Plasma (time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.