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NCT06259435 · ClinicalTrials.gov registry record · NA

Modulating Energy Density in Time-Restricted Eating

A NA study, sponsored by Pennington Biomedical Research Center.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT06259435: Completed NA study, sponsored by Pennington Biomedical Research Center.

NCT06259435 is a NA study that has completed, run by Pennington Biomedical Research Center. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06259435, a NA study, has completed, sponsored by Pennington Biomedical Research Center.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study 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: 1. Insulin resistance and 2. Body weight. Researchers will compare the groups: 1. Following time-restricted eating and given a diet reduced in energy density or 2. Following time-restricted eating and given a diet typically consumed in this population

Primary Outcome

Phosphorylation of serine 312 on insulin receptor substrate 1 in plasma neural-derived exosomes

Interventions

  • BEHAVIORAL Low-energy dense diet
  • BEHAVIORAL Usual diet

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2024-05-29
Est. Completion 2025-12-17
Phase NA

What the finished NCT06259435 record still lists

NCT06259435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Low-energy dense diet is the first listed.

NCT06259435 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06259435 about?

NCT06259435 is a clinical study titled "Modulating Energy Density in Time-Restricted Eating". 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 ...

What is the current status of trial NCT06259435?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2024-05-29. Estimated completion is 2025-12-17.

What interventions are being tested in trial NCT06259435?

The interventions under investigation include: Low-energy dense diet (BEHAVIORAL), Usual diet (BEHAVIORAL).

Who is sponsoring clinical trial NCT06259435?

This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06259435's enrollment target sits among peer trials

40 1447th of 2000 higher than 465 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06259435, the US trial registry maintained by the National Library of Medicine. NCT06259435 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.