DiAL Health Research Study
Aging, Weight Loss, Treatment Adherence
About this trial
This is an interventional treatment trial for Aging
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)
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
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
ad libitum Control
Traditional CR
Adaptive CR
Traditional TRE
Adaptive TRE
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.