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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

About this trial

This is an interventional treatment trial for Aging

Eligibility Criteria

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

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:
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
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
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

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

NCT ID

NCT05549362

First Posted

September 15, 2022

Last Updated

September 13, 2023

Sponsor

Pennington Biomedical Research Center

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

Studies a U.S. FDA-regulated Device Product

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

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

corby.martin@pbrc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Leanne Redman

Phone

225-763-0947

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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