Modulating Energy Density in Time-Restricted Eating | NCT06259435

Studies
Modulating Energy Density in Time-Restricted Eating

NCT06259435

Sponsor

Pennington Biomedical Research Center

Status

Completed

Last Update Posted

Jan 14, 2026Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Insulin Resistance
Body Weight

Interventions

Low-energy dense diet
Usual diet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 29, 2024Actual

Primary Completion Date

Dec 17, 2025Actual

Completion Date

Dec 17, 2025Actual

First Submitted Date

Jan 26, 2024

First Submission Date that Met QC Criteria

Feb 5, 2024

First Posted Date

Feb 14, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2026

Last Update Posted Date

Jan 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low energy dense diet	Experimental	Subjects will be required to follow time-restricted eating and receive a diet low in energy density	Behavioral: Low-energy dense diet
Usual diet	Active Comparator	Subjects will be required to follow time-restricted eating and receive the usual diet.	Behavioral: Usual diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low-energy dense diet	Behavioral	Subjects will follow time-restricted eating of a low energy dense diet	Low energy dense diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brain Insulin Resistance	Phosphorylation of serine 312 on insulin receptor substrate 1 in plasma neural-derived exosomes	8 weeks
Ketones	Ketones	8 weeks
Body weight	Body weight	8 weeks
Peripheral insulin resistance	Homeostasis model assessment of insulin resistance (HOMA-IR)	8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Candida Rebello	Pennington Biomedical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pennington Biomedical Research Center		Baton Rouge	Louisiana	70808	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance
D001835	Body Weight

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Triple

Masking Description

Subjects will be randomly assigned to one of two groups. Except for the Director of the Metabolic Kitchen and the dietitians assigned to the study, all other researchers conducting the study will be blinded to the treatment group assignment of subjects.

Who Masked

ParticipantInvestigatorOutcomes Assessor