AgingNCT05549362
DiAL Health Research Study
A study testing Dial Health Research Study in people with Aging and Weight Loss, run by Pennington Biomedical Research Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Weight Loss, Treatment Adherence
- What is being tested?
- Dial Health Research Study
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Dec 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Dietary Approaches to Longevity and Health
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.
Read the 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
- Conditions
- Aging, Weight Loss, Treatment Adherence
- Being tested
- Dial Health Research Study
- Medical subject headings
- Weight Loss, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dial Health Research StudyOther
To evaluate the feasibility and efficacy of dietary intervention approaches to slow mechanisms of aging.
| Study group | Role | What they receive |
|---|---|---|
| ad libitum Control | Placebo comparator | No treatment control condition. Receives: Other: Dial Health Research Study |
| Traditional CR | Active comparator | A 25% calorie restriction (CR) intervention delivered via traditional in-person sessions. Receives: Other: Dial Health Research Study |
| Adaptive CR | Active comparator | A 25% calorie restriction (CR) intervention delivered via a remote, adaptive, and technology-driven intervention program. Receives: Other: Dial Health Research Study |
| Traditional TRE | Active comparator | An eight-hour time restricted eating (TRE) intervention delivered via traditional in-person sessions. Receives: Other: Dial Health Research Study |
| Adaptive TRE | Active comparator | An eight-hour time restricted eating (TRE) intervention delivered via a remote, adaptive, and technology driven intervention program. Receives: Other: Dial Health Research Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention satisfaction ratings
Intervention satisfaction will be assessed via Likert ratings for each study group.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 10 days over at least 3 timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start2 Dec 2022
- Primary completion16 Jan 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corby K. Martin, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549362
- Sponsor's protocol ID
- PBRC 2021-020
- Status last verified
- Mar 2025
- First submitted
- 15 Sep 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers are encouraged to contact the PIs to request study data.
Publications
Redman LM, Peterson CM, Dutton GR, Drews KL, Broyles ST, Dubin R, Rogers LQ, Champagne CM, Villareal DT, Hsia DS, Cabre HE, Falkenhain K, Spring KE, Diktas HE, Kennedy SF, Martin CK. Clinical Protocol for the Dietary Approaches to Longevity and Health (DiAL Health) Pilot Trial. Curr Dev Nutr. 2026 Jul 25;10(9):109462. doi: 10.1016/j.cdnut.2026.109462. eCollection 2026 Sep.
PubMed 42741276Kennedy SF, Cabre HE, Diktas HE, Falkenhain K, Spring KE, Peterson CM, Dutton GR, Drews KL, Broyles ST, Dubin R, Rogers LQ, Champagne CM, Villareal DT, Hsia DS, Jacobs PG, Rejeski J, Fanning J, Redman LM, Martin CK. Rationale and Design of Traditional and Adaptive Calorie Restriction and Time-Restricted Eating Interventions Used in the Dietary Approaches to Longevity and Health (DiAL Health) Pilot Trial. Curr Dev Nutr. 2026 Jul 25;10(9):109461. doi: 10.1016/j.cdnut.2026.109461. eCollection 2026 Sep.
PubMed 42733503
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Approaches to Longevity and Health
- ClinicalTrials.gov ID
- NCT05549362
- Acronym / sponsor ID
- PBRC 2021-020
- Conditions
- Aging, Weight Loss, Treatment Adherence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ad libitum Control | Placebo comparator | Other: Dial Health Research StudyNo treatment control condition. |
| Traditional CR | Active comparator | Other: Dial Health Research StudyA 25% calorie restriction (CR) intervention delivered via traditional in-person sessions. |
| Adaptive CR | Active comparator | Other: Dial Health Research StudyA 25% calorie restriction (CR) intervention delivered via a remote, adaptive, and technology-driven intervention program. |
| Traditional TRE | Active comparator | Other: Dial Health Research StudyAn eight-hour time restricted eating (TRE) intervention delivered via traditional in-person sessions. |
| Adaptive TRE | Active comparator | Other: Dial Health Research StudyAn eight-hour time restricted eating (TRE) intervention delivered via a remote, adaptive, and technology driven intervention program. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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:
- Lifestyle related factors that would confound outcomes:
- Unwilling or unable to adhere to the rigors of the protocol or failure to complete the behavioral run-in task (at least 80% compliance)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dial Health Research StudyTo evaluate the feasibility and efficacy of dietary intervention approaches to slow mechanisms of aging. | Other | Adaptive CR, Adaptive TRE, Traditional CR, Traditional TRE, ad libitum Control |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Derived from this study: PubMed 42741276Redman LM, Peterson CM, Dutton GR, Drews KL, Broyles ST, Dubin R, Rogers LQ, Champagne CM, Villareal DT, Hsia DS, Cabre HE, Falkenhain K, Spring KE, Diktas HE, Kennedy SF, Martin CK. Clinical Protocol for the Dietary Approaches to Longevity and Health (DiAL Health) Pilot Trial. Curr Dev Nutr. 2026 Jul 25;10(9):109462. doi: 10.1016/j.cdnut.2026.109462. eCollection 2026 Sep.
- Derived from this study: PubMed 42733503Kennedy SF, Cabre HE, Diktas HE, Falkenhain K, Spring KE, Peterson CM, Dutton GR, Drews KL, Broyles ST, Dubin R, Rogers LQ, Champagne CM, Villareal DT, Hsia DS, Jacobs PG, Rejeski J, Fanning J, Redman LM, Martin CK. Rationale and Design of Traditional and Adaptive Calorie Restriction and Time-Restricted Eating Interventions Used in the Dietary Approaches to Longevity and Health (DiAL Health) Pilot Trial. Curr Dev Nutr. 2026 Jul 25;10(9):109461. doi: 10.1016/j.cdnut.2026.109461. eCollection 2026 Sep.
- Individual participant dataSharing planned: Yes. Researchers are encouraged to contact the PIs to request study data.
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Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dial Health Research Study in people with Aging and Weight Loss, run by Pennington Biomedical Research Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention satisfaction ratings (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05549362, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.