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