Insulin ResistanceMEDITRENCT06259435
Modulating Energy Density in Time-Restricted Eating
A study testing Low-energy dense diet and Usual diet in people with Insulin Resistance and Body Weight, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The goal of this randomized controlled trial is to test the effect of time-restricted eating (14-hour fast, 10-hour eating window) of a low-energy dense diet (reduced calories per gram of food) in older adults with obesity and insulin resistance. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Insulin Resistance, Body Weight
- What is being tested?
- Low-energy dense diet and Usual diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2024to 17 Dec 2025
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥ 30kg/m2.
- Mini-Mental State Examination (MMSE) > 25
- Geriatric Depression Scale-15 (GDS-15) < 9
- Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3.
Who cannot join
- Diagnosis of Type 2 diabetes received more than five years ago
- Diagnosis of type 1 diabetes
- Evidence of clinically significant renal dysfunction or disease
- History of malignancy during the past five years
- Being treated with systemic steroids, olanzapine, or clozapine
- Being treated with prescription medications for obesity
Show all 9Show fewer
- Being treated with thiazolidinediones, glucagon-like-receptor agonists, Dipeptidyl Peptidase IV inhibitors, and insulin
- Weight change > 3 kg in the preceding three months
- Any disease or condition that precludes testing of the study outcomes or makes it unsafe to consume the foods being tested in the study, or subjects are otherwise deemed to be unsuitable for participation in the study (determined by the investigative team)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
The goal of this randomized controlled trial is to test the effect of time-restricted eating (14-hour fast, 10-hour eating window) of a low-energy dense diet (reduced calories per gram of food) in older adults with obesity and insulin resistance. The study aims to determine if modulating the energy density of the diet reduces:
- Insulin resistance and
- Body weight.
Researchers will compare the groups:
- Following time-restricted eating and given a diet reduced in energy density or
- Following time-restricted eating and given a diet typically consumed in this population
Read the detailed description
The study is an eight-week randomized controlled double-blinded clinical trial. Participants will follow time-restricted eating (14-hour fast, 10-hour eating window), and will be randomized to a diet low in energy density or the usual diet. Meals will be prepared in a metabolic kitchen and dispensed to participants. Dietitians will monitor dietary compliance. A blood sample will be drawn and body weight will be measured before starting the intervention and after completing it.
- Conditions
- Insulin Resistance, Body Weight
- Being tested
- Low-energy dense diet, Usual diet
- Medical subject headings
- Insulin Resistance, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-energy dense dietBehavioural
Subjects will follow time-restricted eating of a low energy dense diet
Usual dietBehavioural
Subjects will follow time-restricted eating of the usual diet
| Study group | Role | What they receive |
|---|---|---|
| Low energy dense diet | Experimental | Subjects will be required to follow time-restricted eating and receive a diet low in energy density Receives: Behavioral: Low-energy dense diet |
| Usual diet | Active comparator | Subjects will be required to follow time-restricted eating and receive the usual diet. Receives: Behavioral: Usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Insulin Resistance
Phosphorylation of serine 312 on insulin receptor substrate 1 in plasma neural-derived exosomes
Measured: 8 weeks
Ketones
Ketones
Measured: 8 weeks
Body weight
Body weight
Measured: 8 weeks
Peripheral insulin resistance
Homeostasis model assessment of insulin resistance (HOMA-IR)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start29 May 2024
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- 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
- Subjects will be randomly assigned to receive a diet low in energy density or the usual diet.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candida Rebello, Pennington Biomedical Research Center
- Investigators
- Candida Rebello, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259435
- Sponsor's protocol ID
- PBRC-2023-049
- Acronym
- MEDITRE
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Energy Density in Time-Restricted Eating
- ClinicalTrials.gov ID
- NCT06259435
- Acronym / sponsor ID
- MEDITRE / PBRC-2023-049
- Conditions
- Insulin Resistance, Body Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 29 May 2024 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 14 Feb 2024 (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.
The goal of this randomized controlled trial is to test the effect of time-restricted eating (14-hour fast, 10-hour eating window) of a low-energy dense diet (reduced calories per gram of food) in older adults with obesity and insulin resistance. The study aims to determine if modulating the energy density of the diet reduces:
- Insulin resistance and
- Body weight.
Researchers will compare the groups:
- Following time-restricted eating and given a diet reduced in energy density or
- Following time-restricted eating and given a diet typically consumed in this population
Detailed description
The study is an eight-week randomized controlled double-blinded clinical trial. Participants will follow time-restricted eating (14-hour fast, 10-hour eating window), and will be randomized to a diet low in energy density or the usual diet. Meals will be prepared in a metabolic kitchen and dispensed to participants. Dietitians will monitor dietary compliance. A blood sample will be drawn and body weight will be measured before starting the intervention and after completing it.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to receive a diet low in energy density or the usual diet.
| Arm | Type | Receives |
|---|---|---|
| Low energy dense diet | Experimental | Behavioral: Low-energy dense dietSubjects will be required to follow time-restricted eating and receive a diet low in energy density |
| Usual diet | Active comparator | Behavioral: Usual dietSubjects will be required to follow time-restricted eating and receive the usual diet. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) ≥ 30kg/m2.
- Mini-Mental State Examination (MMSE) > 25
- Geriatric Depression Scale-15 (GDS-15) < 9
- Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3.
Key exclusion criteria (9 listed)
- Diagnosis of Type 2 diabetes received more than five years ago
- Diagnosis of type 1 diabetes
- Evidence of clinically significant renal dysfunction or disease
- History of malignancy during the past five years
- Being treated with systemic steroids, olanzapine, or clozapine
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 |
|---|---|---|
| Low-energy dense dietSubjects will follow time-restricted eating of a low energy dense diet | Behavioural | Low energy dense diet |
| Usual dietSubjects will follow time-restricted eating of the usual diet | Behavioural | Usual diet |
Primary outcome
Brain Insulin Resistance
Time frame: 8 weeks
Phosphorylation of serine 312 on insulin receptor substrate 1 in plasma neural-derived exosomes
Ketones
Time frame: 8 weeks
Ketones
Body weight
Time frame: 8 weeks
Body weight
Peripheral insulin resistance
Time frame: 8 weeks
Homeostasis model assessment of insulin resistance (HOMA-IR)
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 14 Jan 2026.
- 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.
Candida Rebello principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-energy dense diet and Usual diet in people with Insulin Resistance and Body Weight, run by Pennington Biomedical Research Center 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 4 inclusion and 9 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 14 Jan 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?
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?
Brain Insulin Resistance (time frame: 8 weeks). The study lists 4 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 14 Jan 2026.