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DiAL Health Research Study

Primary Purpose

Aging, Weight Loss, Treatment Adherence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dial Health Research Study
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy male or non-pregnant pre-menopausal female, 25-45 years of age, inclusive
  2. BMI ≥22kg/m2 and <30kg/m2
  3. Screening lab values within normal limits, or deemed not clinically significant
  4. Stable body weight (less than ± 2kg) in the past 6 months
  5. Regularly wake up between 5-8 AM

Exclusion Criteria

  1. 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
  2. Regular (daily) use of medications for chronic medical conditions.
  3. History or clinical manifestation of:

    1. 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
    2. Anemia (Hb <10 g/dL or hematocrit < 30)
    3. Diabetes or fasting glucose ≥ 126 mg/dL or HbA1c ≥ 6.5% at screening
    4. Hypertension (Systolic Blood Pressure >140 mmHg & Diastolic Blood Pressure >90 mmHg)
    5. Cancer requiring treatment in the past 5 years (except for non-melanoma skin cancer)
    6. Low Bone mineral density z-score < -2.0 of the hip (total hip or femoral neck) or lumbar spine (L1-L4)
    7. Depression as determined by the Beck Depression Inventory-II > 19
    8. Pregnant, postpartum (< 12 months) or lactating females or attempting to become pregnant in the next 7 months
    9. Current or history (within the past 5 years) of an eating disorder
    10. Asthma or sleep apnea
  4. Lifestyle related factors that would confound outcomes:

    1. Non-conventional eating patterns (vegan, paleo, fasting, etc.) and eating duration (<11 hours per day)
    2. Drug or alcohol abuse (up to 14 drinks a week are allowed) within the past 2 years
    3. Current smoking, vaping or use of tobacco products within the past 6 months
    4. Currently participating or recently engaged (4 consecutive weeks in the past 3 months) in heavy aerobic activity (e.g., jogging, running, or riding fast on a bicycle) ≥ 240 minutes per week or heavy resistance training ≥ 3 times per week that results in heavy breathing and sweating.
    5. Perform overnight shift work > 1 day/week or plan to cross more than 2 time zones within 1 month of study assessments
  5. Unwilling or unable to adhere to the rigors of the protocol or failure to complete the behavioral run-in task (at least 80% compliance)

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Pennington Biomedical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

ad libitum Control

Traditional CR

Adaptive CR

Traditional TRE

Adaptive TRE

Arm Description

No treatment control condition.

A 25% calorie restriction (CR) intervention delivered via traditional in-person sessions.

A 25% calorie restriction (CR) intervention delivered via a remote, adaptive, and technology-driven intervention program.

An eight-hour time restricted eating (TRE) intervention delivered via traditional in-person sessions.

An eight-hour time restricted eating (TRE) intervention delivered via a remote, adaptive, and technology driven intervention program.

Outcomes

Primary Outcome Measures

Intervention satisfaction ratings
Intervention satisfaction will be assessed via Likert ratings for each study group.
Percent CR (CR groups only)
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)
Percent adherence to the eating window in the time-restricted eating groups will be assessed by continuous glucose monitoring.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2022
Last Updated
September 13, 2023
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT05549362
Brief Title
DiAL Health Research Study
Official Title
Dietary Approaches to Longevity and Health
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Weight Loss, Treatment Adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ad libitum Control
Arm Type
Placebo Comparator
Arm Description
No treatment control condition.
Arm Title
Traditional CR
Arm Type
Active Comparator
Arm Description
A 25% calorie restriction (CR) intervention delivered via traditional in-person sessions.
Arm Title
Adaptive CR
Arm Type
Active Comparator
Arm Description
A 25% calorie restriction (CR) intervention delivered via a remote, adaptive, and technology-driven intervention program.
Arm Title
Traditional TRE
Arm Type
Active Comparator
Arm Description
An eight-hour time restricted eating (TRE) intervention delivered via traditional in-person sessions.
Arm Title
Adaptive TRE
Arm Type
Active Comparator
Arm Description
An eight-hour time restricted eating (TRE) intervention delivered via a remote, adaptive, and technology driven intervention program.
Intervention Type
Other
Intervention Name(s)
Dial Health Research Study
Intervention Description
To evaluate the feasibility and efficacy of dietary intervention approaches to slow mechanisms of aging.
Primary Outcome Measure Information:
Title
Intervention satisfaction ratings
Description
Intervention satisfaction will be assessed via Likert ratings for each study group.
Time Frame
6 months
Title
Percent CR (CR groups only)
Description
Percent calorie restriction (CR) will be quantified for the 2 CR groups via doubly labeled water and the intake balance method.
Time Frame
6 months
Title
Percent adherence to TRE (TRE groups only)
Description
Percent adherence to the eating window in the time-restricted eating groups will be assessed by continuous glucose monitoring.
Time Frame
10 days over at least 3 timepoints

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Anemia (Hb <10 g/dL or hematocrit < 30) Diabetes or fasting glucose ≥ 126 mg/dL or HbA1c ≥ 6.5% at screening Hypertension (Systolic Blood Pressure >140 mmHg & Diastolic Blood Pressure >90 mmHg) Cancer requiring treatment in the past 5 years (except for non-melanoma skin cancer) Low Bone mineral density z-score < -2.0 of the hip (total hip or femoral neck) or lumbar spine (L1-L4) Depression as determined by the Beck Depression Inventory-II > 19 Pregnant, postpartum (< 12 months) or lactating females or attempting to become pregnant in the next 7 months Current or history (within the past 5 years) of an eating disorder Asthma or sleep apnea Lifestyle related factors that would confound outcomes: Non-conventional eating patterns (vegan, paleo, fasting, etc.) and eating duration (<11 hours per day) Drug or alcohol abuse (up to 14 drinks a week are allowed) within the past 2 years Current smoking, vaping or use of tobacco products within the past 6 months Currently participating or recently engaged (4 consecutive weeks in the past 3 months) in heavy aerobic activity (e.g., jogging, running, or riding fast on a bicycle) ≥ 240 minutes per week or heavy resistance training ≥ 3 times per week that results in heavy breathing and sweating. Perform overnight shift work > 1 day/week or plan to cross more than 2 time zones within 1 month of study assessments Unwilling or unable to adhere to the rigors of the protocol or failure to complete the behavioral run-in task (at least 80% compliance)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corby Martin
Phone
225-763-2585
Email
corby.martin@pbrc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Leanne Redman
Phone
225-763-0947
Email
leanne.redman@pbrc.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Peterson
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Researchers are encouraged to contact the PIs to request study data.
IPD Sharing Time Frame
Following data collection, data cleaning, data lock, data analysis, and submission of the primary outcome paper.
IPD Sharing Access Criteria
An institutional signing official from the researcher's institution is required to execute a Data Transfer Agreement.

Learn more about this trial

DiAL Health Research Study

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