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Clinical Trials/NCT05549362
NCT05549362
Active, not recruiting
Not Applicable

Dietary Approaches to Longevity and Health

Pennington Biomedical Research Center2 sites in 1 country90 target enrollmentDecember 2, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
Pennington Biomedical Research Center
Enrollment
90
Locations
2
Primary Endpoint
Intervention satisfaction ratings
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to conduct a five-arm pilot and feasibility trial in healthy, young individuals without obesity to evaluate the feasibility and efficacy of dietary intervention approaches to slow mechanisms of aging.

Detailed Description

Nutritional interventions are one of the most promising non-pharmacological approaches that attenuate aging. Continuous calorie restriction (CR), the most studied intervention, extends lifespan in animals and, in humans, slows biological aging and improves healthspan (e.g., disease risk factors, quality of life). In the largest clinical trial of CR in humans (CALERIE 2), adherence to 25% CR waned to \~12% CR over 2 years, which questions the practicality of such interventions over longer periods. CALERIE 2, however, did not benefit from a more advanced approach, namely a Just-in-Time Adaptive Intervention (JITAI), which tailors and optimizes the intervention for each subject. JITAIs strive to provide individuals with the right type and amount of personalized support when necessary by adapting the intervention delivery to the present adherence, needs and environment of the subject. This is accomplished by the use of mobile health (mHealth) technology (smartphones, sensors) to objectively evaluate intervention adherence in real-time and to adapt intervention delivery to each individual over time. The near real-time collection of ecologically valid and objective data from people in their free-living environment dramatically improves the ability to promote adherence and subject engagement. Newer approaches, such as time-restricted eating (TRE), where food intake is restricted to less than a 10-hour period of the day, may also benefit aging. Short-term pilot studies of TRE showed that, independent of CR, eating over a 6-hour window that began in the morning significantly improved diabetes and cardiovascular risk factors (healthspan) and biomarkers of primary aging (e.g., autophagy, oxidative stress, nutrient sensing). The long-term feasibility of TRE is unknown, and it is unclear if TRE interventions with JITAI designs enhance intervention feasibility and adherence in the context of healthy aging. The current trial will examine the feasibility and preliminary efficacy of two CR and two TRE interventions to modulate healthspan and biomarkers of aging in healthy, young (25-45 years) individuals. In a 5-arm pilot and feasibility trial, 90 people without obesity (BMI 22-29.9 kg/m2) will be randomized to either ad libitum Control, Traditional CR, Adaptive CR, Traditional TRE, or Adaptive TRE for 24 weeks (n=18/group) for six months

Registry
clinicaltrials.gov
Start Date
December 2, 2022
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Corby K. Martin

Professor

Pennington Biomedical Research Center

Eligibility Criteria

Inclusion Criteria

  • Healthy male or non-pregnant pre-menopausal female, 25-45 years of age, inclusive
  • BMI ≥22kg/m2 and \<30kg/m2
  • Screening lab values within normal limits, or deemed not clinically significant
  • Stable body weight (less than ± 2kg) in the past 6 months
  • Regularly wake up between 5-8 AM
  • Exclusion Criteria
  • History of prior bariatric surgery, active gallstone disease, extensive bowel resection or any disease or condition that seriously affects body weight and/or body composition
  • Regular (daily) use of medications for chronic medical conditions.
  • History or clinical manifestation of:
  • Significant chronic metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic, circadian, sleep disorders, reproduction or other condition that would not be considered 'healthy' in opinion of the investigator

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Intervention satisfaction ratings

Time Frame: 6 months

Intervention satisfaction will be assessed via Likert ratings for each study group.

Percent CR (CR groups only)

Time Frame: 6 months

Percent calorie restriction (CR) will be quantified for the 2 CR groups via doubly labeled water and the intake balance method.

Percent adherence to TRE (TRE groups only)

Time Frame: 10 days over at least 3 timepoints

Percent adherence to the eating window in the time-restricted eating groups will be assessed by continuous glucose monitoring.

Study Sites (2)

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