Please select the eligibility criteria that correspond to the clinical trial below.
Title: Dietary Energy Restriction and Metabolic Aging in Humans
Brief Summary: The purpose of this study is to develop an effective calorie restricted diet.


Options:
A: Inclusion Criteria:

* Aged \>35-75 years
* Waist circumference above cut-off for high risk of cardio-metabolic disease of \>102 cm in men with a Europid, Black African and Caribbean, and other ethnic background and \>88 cm in women with a Europid, Black African and Caribbean, and other ethnic background (WHO, 2008), and ≥90 cm in men and ≥80 cm in women with an Asian background (South Asian and East Asian) (Misra et al., 2009).

REFERENCES Misra A, Chowbey P, Makkar BM, Vikram NK, Wasir JS, Chadha D, et al. (2009). Consensus statement for diagnosis of obesity, abdominal obesity and the metabolic syndrome for Asian Indians and recommendations for physical activity, medical and surgical management. The Journal of the Association of Physicians of India 57: 163170.

WHO (2008). Waist circumference and waist-hip ratio: report of a WHO expert consultation. Geneva, 8-11 December 2008.

Exclusion Criteria:

* Kidney or cardiovascular disease, cancer, diabetes, gastrointestinal or chronic liver disease;
* previous bariatric surgery or other major surgery (e.g. organ transplantation);
* unable to provide written informed consent;
* have significant psychiatric disorder (e.g. schizophrenia, anxiety, panic disorder, attention deficit disorder, post-traumatic stress disorder, obsessive compulsive disorder) or uncontrolled depression;
* participated in a weight management drug trial in the previous 3 months;
* have binge eating behaviour;
* have uncontrolled epilepsy;
* alcohol or substance abuse;
* currently pregnant, lactating, or planning pregnancy within the study period;
* are using medication clinically deemed to affect metabolic rate and weight (e.g. beta blockers, corticosteroids, diuretics, etc);
* lactose intolerant.
B: Inclusion Criteria:

* Healthy men and women (based on standard laboratory tests and a screening examination)
* 20-42 years of age
* BMI in the range 25-29.9 kg/m2
* Proportional representation of minorities in the Greater Boston Area (7 percent Black, 11 percent Hispanic, 82 percent non-Hispanic white)
* Able to accurately complete a food record
* Stage of change \>1 for weight loss and changing dietary intake
* Must have an immediate adult family member who is supportive of weight loss

Exclusion Criteria:

* Known serious disorders that affect longevity, energy metabolism, body composition and immune responsiveness, including diabetes, cancer, heart disease, cachexia, eating disorders (anorexia and bulimia and any vomiting for means of weight control), depression, alcoholism, inflammatory disorders and AIDS, and individuals taking medicine that is anticipated to influence lifespan or energy metabolism
* Abnormal kidney function as assessed by serum creatinine, BUN and urinalysis, and abnormal liver function as assessed by SGPT, SGOT alkaline phosphatase, and bilirubin, abnormal normal thyroid function as assessed by serum T4 and TSH and fasting serum glucose levels \<125 mg/dl
* Smoking, highly restrained eating, reported endurance training (participation in sports or training \>12 hours per week), alcohol intake of 14 oz. per week or more, major medical and/or psychiatric disorders, plans to have a child within 3 years (1 year for Pilot study), past childbearing (for women) within the last 2 years, or breastfeeding within the past year
* Amputees
* Have required treatment for any psychiatric disorder
* Gained or lost \>15 lb weight within the past year, or taking medications known or suspected to have an important influence on lifespan, energy metabolism, body composition or immune function
* Early death from cardiovascular diseases, cancer, or a diabetes-related illness (before the age of 45 years) in one or both of the parents
* Unable to remain in the program for at least 1 year, or unsuitable for home-based programs (including individuals reporting binge eating disorders or clinical depression, and women intending to become pregnant)
C: Inclusion Criteria:

1. - 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 overweight range (i.e. 22 to 28 kg/m2),
2. - Participants who are eating usual US diets and are sedentary to moderately active (i.e. not exercise trained).
3. - Participants have at least one of these metabolic abnormalities: pre-hypertension or hypertension (i.e. systolic blood pressure \> 120 mmHg or diastolic blood pressure \> 80 mmHg or specific treatment of previously diagnosed hypertension)10, sub-optimal lipid levels (i.e. LDL-cholesterol \> 100 mg/dl or HDL-cholesterol \< 59 mg/dl or specific treatment for this lipid abnormality)11, impaired fasting glucose or glucose intolerance (i.e. fasting glucose \> 100 mg/dl or 2 hr-glucose during OGTT with a glucose load of 75 g \> 140 mg/dl or specific treatment for previously diagnosed type 2 diabetes)12, or high-risk waist circumference (≥ 94 cm in men and ≥ 80 cm in women)13.

Exclusion Criteria:

- 1 - History of any chronic disease process that could interfere with interpretation of results 2 - Smoking, pregnancy, alcoholism, psychiatric problems, life situations that would interfere with study participation and compliance.

3 - Currently eating diet similar to Mediterranean diet based on dietary and food frequency questionnaires and 4-day food diary.
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