Please select the eligibility criteria that correspond to the clinical trial below.
Title: Dietary Energy Restriction and Metabolic Aging in Humans
Brief Summary: This study is one of three CALERIE trials that test the hypothesis that a reduced calorie, nutritionally sound diet increases the length of life and prevents some age-related chronic diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are participating in the CALERIE trial represent a diversity of subject populations and interventional strategies.


Options:
A: Inclusion Criteria:

1. Healthy, non-diabetic women with "≥20 pound weight gain since their twenties"
2. Age: 35-55
3. Peri-menopausal or postmenopausal status
4. Body Mass Index (BMI) 25-35 kg/m2
5. Either:

   1. a single blood pressure recording ≥135/85 or the use of blood pressure medication OR
   2. HDL≤50mg/dl or triglycerides ≥150 mg/dl or the use of lipid modifying medication
6. Area-under-the-curve (AUC-)insulin level\>100mcgU/ml along with normal fasting (≤100 mg/dl) \& postprandial ((≤200 mg/dl) glucose determinations following a 75-gram standard oral glucose tolerance test.

   -

Exclusion Criteria:

1. known diabetes, fasting blood sugar ≥100 mg/dl or HbA-1-C≥6.0%
2. known hepatic disease or ALT\>40
3. known renal disease or creatinine ≥ 1.4
4. known severe pulmonary disease
5. chronic acidosis of any etiology
6. Congestive heart failure (NYS Category 1), treated or untreated
7. Cancer - active within 5 years
8. current alcoholism or other substance abuse
9. co-morbid psychiatric disorder, which in the opinion of the screening physician would require concomitant psychotherapy as part of obesity management
10. currently untreated thyroid abnormality (TSH≤0.2 or ≥4mIU/L)
11. pregnancy or contemplation of pregnancy
12. use of TZD or metformin within the past year
13. allergy to TZD or biguanide
14. use of FDA approved or alternate obesity agent within 6 months of the study
15. history of pseudotumor cerebri
16. other impairment, such as a history of medication noncompliance, which in the judgment of the screening clinician, would preclude active study participation.
17. history of known or suspected heart disease
B: Inclusion Criteria:

* Age: \> 18 years of age
* Women: Pre-menopausal (self-report) and \<50 years of age
* Men: \<50 years of age
* BMI (body mass index): 27-40 kg/m2 (need to lose \>10% body weight to achieve healthy BMI)
* Body weight stable for the last two months, and not actively on a weight loss plan
* No plans to move from the area over the next two years
* Available and able to participate in the evaluations and intervention for the study period
* Willing to accept random assignment
* To enhance study generalizability, people on medications not noted below as specific exclusions can
* participate if they have been stable on such medications for at least three months
* Ability and willingness to give written informed
* No known active psychiatric illness

Exclusion Criteria:

Subjects with the following conditions will be excluded (determined by self-report):

* Pregnant, lactating, within 6 months post-partum, or planning to become pregnant in the next 2 years
* Diabetes (type 1 and 2) or history of gestational diabetes or on hypoglycemic medications for any other indication
* Prevalent diseases: Malabsorption, renal or liver disease, active neoplasms, recent myocardial infarction (\<6 months)(patient self-report and, if available, review of labs from primary care provider)
* Smokers (because of effect on weight and lipids)
* History of serious arrhythmias, or cerebrovascular disease
* Uncontrolled hyper- or hypothyroidism (TSH not within normal limits)
* Medications: Lipid lowering, antihypertensive medications, and those known to affect weight/energy expenditure
* Excessive alcohol intake (self-reported, \>3 drinks/day)
* Musculoskeletal disorders precluding regular physical activity
* Unable to follow either of the two study diets for reasons of food allergies or other (e.g., vegan)
* Currently under psychiatric care, or taking psychiatric medications
* Inability to communicate effectively with study personnel
C: Inclusion Criteria

* Healthy men and women
* Body mass index (BMI) = 25-30
* Slightly overweight, \< 275 lbs
* Women 25-45, pre-menopause
* Men 25-50
* Not traveling often or planning to move

Exclusions:

* Cardiovascular disease or blood pressure greater than 160/90
* Diabetes
* Major psychiatric disorders
* Eating disorders
* Post obese; previous BMI \> 32
* Weight change of more than ten pounds in the past 90 days
* Over 275 pounds
* Smoking
* Regular exercise, more than twice per week
* Current prescription drug use, except oral contraceptives
* Alcoholism or substance abuse
* Pregnant or lactating (breast feeding), planning to become pregnant, or not regularly using contraception
* Abnormal electrocardiogram (EKG)
* Local resident for less than one year
* Occupations requiring full alertness and motor skills, with no allowance for a chance of postural dizziness (airline pilots, etc.)
* Injuries by any metallic object that is still present in the body
* Braces, non-removable dentures, or non-removable bridgework
D: Inclusion Criteria:

* Willing to sign a consent form.
* BMI during screening ≥25 kg/m2 (eligibility for weight loss support group)
* Participants must not have had any surgical procedures influencing weight regulation to include, but not limited to, gastric bypass, other bariatric surgeries, resection of small or large intestine leading to malabsorption, gastric resection for ulcers or cancer, and esophageal resection
* Intention to follow recommended program and complete outcome assessments and requested self-monitoring.
* Obtain a physician's clearance form

Answer: C