PreDiabetesTRIMNCT03527368
The Time-Restricted Intake of Meals Study
A study testing Time-restricted feeding and Usual feeding pattern in people with PreDiabetes and Obesity, run by Johns Hopkins University at 1 site in United States.
Trial summary
TRIM is a randomized, controlled feeding study to evaluate if eating earlier in the day vs. later in the day impacts weight and glucose homeostasis. Read more about this study
- Who is it for?
- Ages 21 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Obesity
- What is being tested?
- Time-restricted feeding and Usual feeding pattern
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prediabetes defined by HbA1c 5.7-6.4%, or type 2 diabetes with HbA1c 6.5-6.9%
- Class I-III obesity (BMI 30-50 kg/m2)
- If on medications for hypertension, stable regimen for at least past 6 months
- Willingness to adjust timing of feeding
- Willingness and ability to eat study diet and nothing else during run-in and intervention
- Willingness to complete measurement procedures
Who cannot join
- Moderate to severe obstructive sleep apnea
- Shift work;
- Other sleep/circadian disorders: e.g., circadian phase delay or phase advance; restless legs syndrome, insomnia, narcolepsy, habitual sleep <6 hours/night
- Routinely ate within compressed time window in the past year (e.g., routinely eats all food within an 10-hour or narrower window, follows an intermittent fasting protocol)
- Renal dysfunction (estimated Glomerular Filtration Rate (GFR) <30 using the simplified Chronic Kidney Disease (CKD) Epidemiology Collaboration (EPI) equation 34)
- Use of glucose-lowering medications, weight loss medications, medications for sleep disorders (sedative/hypnotic drugs, stimulants), lithium, systemic corticosteroids, diuretics, blood thinners requiring regular monitoring (e.g. warfarin), anti-psychotic drugs and antiretroviral therapy
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- Body weight >400 pounds (limitation of facility scales)
- >1 drink per day of alcohol
- Active substance use disorder or significant psychiatric/psychologic disorder that would interfere with participation
- Significant food allergies, preferences, intolerances, or dietary supplements that would interfere with diet adherence
- Weight loss or gain of ≥5% during past 6 months
- Pregnant, planning to become pregnant, or breastfeeding
- Planning to start a weight loss program
- Planning to leave the area prior to end of study
- Current participation in another clinical trial
- Cancer diagnosis requiring active treatment in past two years or planned treatment (with exception of localized non-melanoma skin cancer)
- Active inflammatory bowel disease, malabsorption, or history of major gastrointestinal surgery involving bowel resection
- Myocardial infarction or stroke in past 6 months
- Prior bariatric surgery
- Any serious illness that would interfere with participation
- Other conditions or situations at the discretion of the PI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Time-Restricted Intake of Meals Study: A Randomized, Controlled Feeding Study
TRIM is a randomized, controlled feeding study to evaluate if eating earlier in the day vs. later in the day impacts weight and glucose homeostasis.
- Conditions
- PreDiabetes, Obesity
- Being tested
- Time-restricted feeding, Usual feeding pattern
- Medical subject headings
- Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted feedingBehavioural
Participants consume food earlier in the day
Usual feeding patternBehavioural
Participants consume food later in the day
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted feeding | Experimental | Not described Receives: Behavioral: Time-restricted feeding |
| Usual feeding pattern | Other | Comparison Receives: Behavioral: Usual feeding pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
Weight change will be measured in kg
Measured: 12 weeks
Secondary outcomes (4)
Fasting glucose
Change in fasting glucose
Measured: 12 weeks
HOMA-IR
Change in HOMA-IR
Measured: 12 weeks
AUC glucose
Area-under-the-curve for glucose on OGTT
Measured: 12 weeks
Glycated albumin
Glycated albumin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start24 Sep 2018
- Primary completion23 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Nisa Maruthur, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527368
- Sponsor's protocol ID
- IRB00155640
- Other IDs
- 17SFRN33590069
- Acronym
- TRIM
- Status last verified
- May 2021
- First submitted
- 4 May 2018
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Duan D, Carnell S, Pilla SJ, Chung ST, Clark JM, Maruthur NM. Time-Restricted Eating on Appetite and Inflammation in Adults With Obesity and Prediabetes: A Randomized Feeding Study. Obesity (Silver Spring). 2026 Jul 27. doi: 10.1002/oby.70270. Online ahead of print.
PubMed 42508996Duan D, Pham LV, Jun JC, Turkson-Ocran RA, Pilla SJ, Clark JM, Maruthur NM. Effects of time-restricted eating on actigraphy-derived sleep parameters: post hoc analysis of a randomized, isocaloric feeding study. Sleep. 2025 Sep 9;48(9):zsaf089. doi: 10.1093/sleep/zsaf089.
PubMed 40241264Maruthur NM, Pilla SJ, White K, Wu B, Maw MTT, Duan D, Turkson-Ocran RA, Zhao D, Charleston J, Peterson CM, Dougherty RJ, Schrack JA, Appel LJ, Guallar E, Clark JM. Effect of Isocaloric, Time-Restricted Eating on Body Weight in Adults With Obesity : A Randomized Controlled Trial. Ann Intern Med. 2024 May;177(5):549-558. doi: 10.7326/M23-3132. Epub 2024 Apr 19.
PubMed 38639542
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Time-Restricted Intake of Meals Study: A Randomized, Controlled Feeding Study
- ClinicalTrials.gov ID
- NCT03527368
- Acronym / sponsor ID
- TRIM / IRB00155640
- Conditions
- PreDiabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TRIM is a randomized, controlled feeding study to evaluate if eating earlier in the day vs. later in the day impacts weight and glucose homeostasis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-restricted feeding | Experimental | Behavioral: Time-restricted feeding |
| Usual feeding pattern | Other | Behavioral: Usual feeding patternComparison |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Prediabetes defined by HbA1c 5.7-6.4%, or type 2 diabetes with HbA1c 6.5-6.9%
- Class I-III obesity (BMI 30-50 kg/m2)
- If on medications for hypertension, stable regimen for at least past 6 months
- Willingness to adjust timing of feeding
- Willingness and ability to eat study diet and nothing else during run-in and intervention
Key exclusion criteria (21 listed)
- Moderate to severe obstructive sleep apnea
- Shift work;
- Other sleep/circadian disorders: e.g., circadian phase delay or phase advance; restless legs syndrome, insomnia, narcolepsy, habitual sleep <6 hours/night
- Routinely ate within compressed time window in the past year (e.g., routinely eats all food within an 10-hour or narrower window, follows an intermittent fasting protocol)
- Renal dysfunction (estimated Glomerular Filtration Rate (GFR) <30 using the simplified Chronic Kidney Disease (CKD) Epidemiology Collaboration (EPI) equation 34)
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 consume food earlier in the day | Behavioural | Time-restricted feeding |
| Usual feeding patternParticipants consume food later in the day | Behavioural | Usual feeding pattern |
Primary outcome
Weight Change
Time frame: 12 weeks
Weight change will be measured in kg
4 secondary outcomes
Fasting glucose
Time frame: 12 weeks
HOMA-IR
Time frame: 12 weeks
AUC glucose
Time frame: 12 weeks
Glycated albumin
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Derived from this study: PubMed 42508996Duan D, Carnell S, Pilla SJ, Chung ST, Clark JM, Maruthur NM. Time-Restricted Eating on Appetite and Inflammation in Adults With Obesity and Prediabetes: A Randomized Feeding Study. Obesity (Silver Spring). 2026 Jul 27. doi: 10.1002/oby.70270. Online ahead of print.
- Derived from this study: PubMed 40241264Duan D, Pham LV, Jun JC, Turkson-Ocran RA, Pilla SJ, Clark JM, Maruthur NM. Effects of time-restricted eating on actigraphy-derived sleep parameters: post hoc analysis of a randomized, isocaloric feeding study. Sleep. 2025 Sep 9;48(9):zsaf089. doi: 10.1093/sleep/zsaf089.
- Derived from this study: PubMed 38639542Maruthur NM, Pilla SJ, White K, Wu B, Maw MTT, Duan D, Turkson-Ocran RA, Zhao D, Charleston J, Peterson CM, Dougherty RJ, Schrack JA, Appel LJ, Guallar E, Clark JM. Effect of Isocaloric, Time-Restricted Eating on Body Weight in Adults With Obesity : A Randomized Controlled Trial. Ann Intern Med. 2024 May;177(5):549-558. doi: 10.7326/M23-3132. Epub 2024 Apr 19.
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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.
Nisa Maruthur, MD principal investigator
Johns Hopkins University
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 and Usual feeding pattern in people with PreDiabetes and Obesity, run by Johns Hopkins University 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 6 inclusion and 21 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 17 May 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight Change (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03527368, which also lists 3 linked publications.
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 17 May 2021; AzTrials last refreshed its copy on 3 Nov 2026.