DiAL Health Research Study
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.
Conditions:
🦠 Aging 🦠 Weight Loss 🦠 Treatment Adherence
🗓️ Study Start (Actual) 2 December 2022
🗓️ Primary Completion (Estimated) 30 November 2024
✅ Study Completion (Estimated) 30 November 2024
👥 Enrollment (Estimated) 90
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Birmingham, Alabama, United States
📍 Baton Rouge, Louisiana, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 25 Years to 45 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 15 September 2022
  • First Submitted that Met QC Criteria 20 September 2022
  • First Posted 22 September 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 September 2023
  • Last Update Posted 15 September 2023
  • Last Verified September 2023