Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Intermittent Fasting and Caloric Restriction on Total and Regional Body Composition, Cardiometabolic, Oxidative Stress & Plasma Toxin Biomarkers, and Energy Metabolism in Overweight/Obese Men and Women
Brief Summary: This study systematically quantified the effects of intermittent fasting and caloric restriction (IFCR) on total and regional (abdominal) body composition (lean mass and fat mass), blood lipids, toxins, oxidative stress biomarkers, energy expenditure, and substrate utilization in 43 overweight/obese middle-aged men (n=22) and women (n=21). Participants were enrolled in the study as a single cohort and participated in an 12-week trial consisting of two consecutive phases: 1) 1-week baseline, weight maintenance control phase (C), and 2) 11-week weight loss IFCR phase. During the 1 week C phase, volunteers were required to maintain their body weight by consuming their normal food intake; however, during the 11 week IFCR, subjects were instructed to consume 75% of their normal intake to result in a 1-2 lb of body weight loss per week. At the conclusion of the 12 week weight loss study, all 40 participants (3 drop-outs) were invited to enroll in a 12 month follow up study. If they agreed to participate, groups were balanced so there were similar numbers of men and women and were weight-matched. The two groups (n=37, 3 dropped prior to allocation) included: 1) a modified version of the 12 week weight loss intervention that consumes whole foods along with 2 meal replacements (rather than 3) (MR; n=19) or 2) a whole foods diet similar to the Therapeutic Lifestyle Changes diet recommended by the National Institute of Health (TLC, n= 18) and asked to follow these nutritional guidelines ad libitum for the duration of 12 months.


Options:
A: Inclusion Criteria:

* T2D since \< 10 yrs, with HbA1c \> 7 % and BMI: 26-34 kg/m2.
* Only naïve or treated with oral antidiabetic drugs and with anti-hypertensive and lipid-lowering medication will be included.
* Those treated with insulin or GLP-1 analogs or having major liver, heart or kidney illnesses will be excluded.

Exclusion Criteria:

1. Type 1 DM, secondary DM, gestational DM
2. Patients using insulin, TZDs
3. Patients using corticosteroid, herb medication or other medications affecting glucose tolerance
4. Renal dysfunction (Cr \> 1.5mg/dL)
5. Hepatic dysfunction (LFT \> x 3UNL)
6. Anemia (Hg \> 10g/dL)
7. Ischemic heart disease, congestive heart failure
8. Severe diabetic complication (CRF, CVA, PDR, gastroparesis)
9. Infectious disease
10. Malignancy
11. Pregnant women
B: Inclusion Criteria:

* Non-smoking, healthy, but overweight/obese men and women with no known cardiovascular or metabolic diseases as assessed by a medical history and a comprehensive medical examination by their physicians
* Sedentary or lightly active (\<30 min, 2d/wk of structured physical activity) as assessed by a Physical Activity questionnaire
* Overweight or obese (BMI\>27.5 kg/m2; % body fat\>30%)
* Weight stable (+/-2kg) for at least 6 months prior to beginning the study

Exclusion Criteria:

* History of cardiometabolic disease (e.g. diabetes, heart disease, etc) and/or cancer and presently taking medications for these conditions
* Pregnant or may be pregnant, are allergic to milk products or are anorexic or bulimic
C: Inclusion Criteria:

* The participants in this study will be 50 men and women in the 30 to 65 year age range, who have a BMI in the high normal to moderately obese range (i.e. 24 to 35 kg/m2),
* Participants who are eating usual US diets and are sedentary to moderately active (i.e. not exercise trained).

Exclusion Criteria:

* History of any chronic disease process that could interfere with interpretation of results
* Smoking, pregnancy, alcoholism, psychiatric problems, life situations that would interfere with study participation and compliance.
D: 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

Answer: B