COMPLETED

Modulating Energy Density in Time-Restricted Eating

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Modulating Energy Density in Time-Restricted Eating

Quick Facts

Study Start:2024-05-29
Study Completion:2025-12-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06259435

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Body mass index (BMI) ≥ 30kg/m2.
  2. 2. Mini-Mental State Examination (MMSE) \> 25
  3. 3. Geriatric Depression Scale-15 (GDS-15) \< 9
  4. 4. Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3.
  1. 1. Diagnosis of Type 2 diabetes received more than five years ago
  2. 2. Diagnosis of type 1 diabetes
  3. 3. Evidence of clinically significant renal dysfunction or disease
  4. 4. History of malignancy during the past five years
  5. 5. Being treated with systemic steroids, olanzapine, or clozapine
  6. 6. Being treated with prescription medications for obesity
  7. 7. Being treated with thiazolidinediones, glucagon-like-receptor agonists, Dipeptidyl Peptidase IV inhibitors, and insulin
  8. 8. Weight change \> 3 kg in the preceding three months
  9. 9. 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)

Contacts and Locations

Principal Investigator

Candida Rebello
PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center

Study Locations (Sites)

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
United States

Collaborators and Investigators

Sponsor: Pennington Biomedical Research Center

  • Candida Rebello, PRINCIPAL_INVESTIGATOR, Pennington Biomedical Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-29
Study Completion Date2025-12-17

Study Record Updates

Study Start Date2024-05-29
Study Completion Date2025-12-17

Terms related to this study

Additional Relevant MeSH Terms

  • Insulin Resistance
  • Body Weight