Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Time-Restricted Feeding on Fat Loss and Cardiometabolic Risk Factors in Overweight Adults
Brief Summary: Time-restricted feeding (TRF) is a novel type of intermittent fasting that involves eating within a daily period of 10 hours or less, followed by fasting for at least 14 hours daily. Several studies in rodents report that TRF reduces body weight, improves blood sugar control, and reduces the risk of cardiovascular disease-even when food intake is matched to the control group or no weight loss occurs. Preliminary evidence suggests that TRF may also increase weight loss, fat loss, and reduce the risk of diabetes and cardiovascular disease in humans. This study will test whether TRF enhances fat loss and increases weight loss in adults with obesity, relative to conventional dieting alone. In addition, this study will determine whether TRF reduces risk factors for type 2 diabetes and cardiovascular disease and will measure the feasibility and acceptability of TRF.

In conjunction with the parent study described above, four ancillary studies will be conducted:

1. Effect of weight loss on nitrogen metabolism and bacteria in the mouth. The primary endpoints for this ancillary study are plasma and salivary nitrate and nitrite, and the secondary endpoints are salivary nitrate reductase activity and salivary bacterial abundance.
2. Effect of weight loss on several biomarkers related to kidney stones. The primary endpoint for this ancillary study is urinary oxalate, and the secondary endpoints are urinary citrate, chloride, sodium, potassium, calcium, phosphorus, uric acid, and creatinine.
3. Effect of meal timing on blood pressure regulation and kidney function. The primary endpoints of this ancillary study include urinary aldosterone excretion, sodium, potassium, and endothelin, whereas the secondary endpoints include nitric oxide and albumin. Additional exploratory endpoints include renal injury markers (KIM-1, nephrin, and urine albumin-to-creatinine ratio), measures of reactive oxidative stress (e.g., hydrogen peroxide and TBARs), and urinary exosomes. Urine will be analyzed in 12-hour bins to determine how meal timing affects differentially affects these endpoints during the daytime and nighttime. The effects of weight loss on these endpoints may also be considered.
4. Validation of a meal timing questionnaire to assess the distribution of food intake throughout the day.


Options:
A: Inclusion Criteria:

* Are a new patient at the UAB Weight Loss Medicine Clinic
* Aged 25-75 years old
* BMI between 30-60 kg/m2 (inclusive)
* Weigh less than 450 lbs
* Wake up regularly between 4-9 am on most days.

Exclusion Criteria:

* Diagnosed with diabetes, have an HbA1c of ≥6.5%, or are on diabetes medication
* On weight loss medication
* Addition of or withdrawal from a chronic medication within the past 10 weeks
* Clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
* Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
* Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity
* Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
* Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)
* Lost or gained more than 5 lbs of weight in the past month
* Currently perform overnight shift work more than once per week on average
* Regularly eat within a less than 10-hour period each day
* Regularly eat dinner before 6 pm
* Traveled more than two time zones away in the two months prior to enrolling in the trial
* Will travel more than one time zone away during the study
* Pregnant or breastfeeding
B: Inclusion Criteria:

* Are male
* Overweight: Have a body mass index between 25 and 50 kg/m\^2 inclusive (a number calculated from height and weight)
* Are 35-70 years of age
* Have a hemoglobin A1C between 5.5 - 6.4% or prior medical indication of prediabetes
* Have a blood sugar level between 140 and 199 mg/dL two hours after drinking a sugary solution (OGTT)
* Have been eating dinner at least 8.5 hours after eating breakfast at least 90% of the time during the past year
* Have not fasted (go for a day without any food) more than 12 days total during the past year
* Be willing to eat most meals at Pennington Biomedical and/or under supervision
* Not eat any food other than that served by Pennington Biomedical
* Not drink any alcohol, juice, or other beverages that have calories other than what is served by Pennington Biomedical
* Keep water and no-calorie drinks like tea or diet soda the same during both of the timed eating periods
* Be willing to eat your meals according to the fixed schedules

Exclusion Criteria:

* Have diabetes or are on anti-diabetes medication
* Have evidence of cardiovascular disease
* Suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung or nervous system disease
* Evidence of significant gastrointestinal issues or surgery that impacts nutrient absorption
* Regularly use medications such as steroids, beta blockers, and adrenergic-stimulating agents
* Are on any regular medicine that has not had the same dose for 1 month or longer
* Have a clinically significant abnormality as measured by a blood test
* Regularly drink alcohol (more than 2 servings per day)
* Have to do any kind of heavy physical activity
* Currently perform overnight shift work more than one day a week
* Are not able to eat only the food served to you by Pennington Biomedical, while in the study
* Are not able to stop drinking alcohol or other drinks with calories (e.g., soda, juice) other than what is served to you by Pennington Biomedical, while in the study
C: Inclusion Criteria:

* Informed consent obtained
* Body Mass Index (BMI) of 30.0 kg/m\^2 or above
* Body Mass Index (BMI) of 27 kg/m\^2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension
* Stable body weight
* Preceding failed dietary effort

Exclusion Criteria:

* Known type 1 or type 2 diabetes
* Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126 mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2)
* Screening calcitonin of 50 ng/L or above
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
* Personal history of non-familial medullary thyroid carcinoma
* History of acute or chronic pancreatitis
* Obesity induced by drug treatment
* Use of approved weight lowering pharmacotherapy
* Previous surgical treatment of obesity
* History of major depressive disorder or suicide attempt
* Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)
D: Inclusion Criteria:

* Ability to provide informed consent.
* Chinese. (Both parents must be Chinese)
* Age above 21 years old. This study will focus only on adult subjects, and 21 years old is chosen as the age cut off, as it is the recognised legal age of independent consent.
* BMI ≥ 25 kg/m2

Exclusion Criteria:

* Pregnant, or any possibility of being pregnant (based on last menstrual period).
* Lactation.
* Age above 70 years old and/or suffering from cancer, diabetes, or any major cardiovascular disease, respiratory, psychiatric or musculoskeletal morbidity.
* Currently dieting or losing weight
* Unable to tolerate or complete two consecutive days of fasting during a two-day trial before recruitment.
* Unwilling to be randomised into intervention or control group.

Answer: A