Phase
Condition
Weight Loss
Aging
Diabetes Prevention
Treatment
Dial Health Research Study
Clinical Study ID
Ages 25-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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)
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
Pennington Biomedical Research Center
Baton Rouge, Louisiana 70808
United StatesSite Not Available

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