Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Periodic Fasting Versus Daily Energy Restriction on Metabolic Health
Brief Summary: The aim of this study is to examine whether periodic fasting improves markers of diabetes risk and cardiovascular health, and will compare this to the effects observed with daily dieting by energy restriction, and also with no change in energy intake.

It is hypothesized that periodic fasting, with or without weight loss, will be as effective as daily energy restriction to improve markers of metabolic health and energy metabolism.


Options:
A: Inclusion Criteria:

* Male or female
* Body mass index (BMI) between 30.0 and 40 kg/m2
* Age between 25 and 65 years
* Sedentary (light exercise less than 1 h per week) or moderately active (moderate exercise 1 to 2 h per week)
* Weight stable for \>3 months prior to the beginning of the study (gain or loss \<4 kg)
* Able to give written informed consent

Exclusion Criteria:

* Smoker
* Diabetic
* History of cardiovascular disease (myocardial infarction or stroke)
* Taking weight loss medications
* History of eating disorders
* Night-shift workers
* Perimenopausal
* Pregnant or trying to become pregnant
B: Inclusion Criteria:

* Body mass index (BMI) between 25 and 42 kg/m2
* weight stable (\<5% fluctuation in body weight for the 6 months prior to study entry)

Exclusion Criteria:

* history of cardiovascular disease, diabetes, major psychiatric disorders, and eating disorders
* use of prescribed or non-prescribed medications with may affect energy metabolism, gastrointestinal function, body weight, or appetite
* recent weight changes in 3 months prior to study entry
* uncontrolled asthma, current fever, upper respiratory infections
* individuals who regularly perform high intensity exercise (\>2 sessions per week)
* pregnancy, lactation (breast feeding), women who are planning to become pregnant
* current intake of \>140g of alcohol per week
* current smoker of cigarettes/cigars/marijuana
* current intake of any illicit substance
* experience claustrophobia in confined spaces
* has donated blood within the past 3 months
* unable to comprehend the study protocol
* experiences migraines
C: 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)
D: Inclusion Criteria:

* Ambulatory, male or female, 21-65 years of age
* A body mass index (BMI) of 23-34.9
* Generally healthy and having no significant difficulty with digestion of food
* Has been generally weight stable for the past six months
* Willing to discontinue use of any (non-study) multivitamin or Vitamin D supplements during the study
* Willing and able to give written informed consent
* Clearly understands the procedures and study requirements
* Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol
* Able to communicate, including reading, in English

Primary Exclusion Criteria:

* Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug in the past 30 days
* History of allergy or sensitivity to any component of the study products including milk, soy and almonds
* Donation of blood with 30 days prior to screening/baseline
* Inability to provide a venous blood sample
* Participation in another study within 30 days prior to baseline/screening
* Being pregnant or planning on becoming pregnant during study participation; or breast feeding
* Having been diagnosed, received medical treatment or taking medication daily for the following medical condition(s):
* Diabetes mellitus
* Eating disorder
* Acute or chronic inflammatory disease or autoimmune disease
* Cardiovascular disease
* Gastrointestinal disease including gallbladder problems, gallstones or biliary tract obstruction
* Thyroid disease (unless on a stable dose of medication for 3 months prior to screening and unlikely to change medication or dose during the study)
* Hypertension (unless on a stable dose of medication for 3 months prior to screening and unlikely to change medication or dose during the study)
* Psychiatric disorder
* Neurologic condition/disease
* Cancer (unless skin cancer other than melanoma which has been treated \> 3 years prior to Baseline/screening)
* Active or chronic liver, pancreatic and kidney disease
* Blood coagulation disorder
* Other condition or medication use that would preclude participation in the study in the judgment of the investigator/sub-investigator (Sub-I)
* Currently taking or having taken within the 30 days prior to screening/baseline any hormone replacement therapy (including DHEA (dehydroepiandrosterone), estrogen, progesterone, or testosterone; except those utilized as a method of birth control and which have been taken for \> 3 months, with no anticipated change for the duration of the study)
* Currently taking any of the nutritional supplements used in the study and unwilling to discontinue use at least 14 days prior to screening.
* Currently taking a medication or nutritional supplement specifically for weight loss and unwilling to discontinue use 14 days prior to the first dosing of study supplements
* Currently participating in a weight loss program and unwilling to discontinue participation prior to enrollment into the study
* Currently taking an anti-coagulant, anti-platelet medication or a glucose lowering medication
* Having had a surgical procedure or having an internal medical device which, in the judgment of the PI/Sub-I, would preclude participation in the study
* Having abnormal screening laboratory test values including bilirubin \> 2.5 x ULN (upper limit of normal), AST/SGOT(aspartate aminotransferase/serum glutamin oxaloacetic transaminase) and ALT/SGPT (alanine aminotransferase/serum glutamic pyruvic transaminase) \> 2.5 x ULN, serum creatinine \> 1.5 mg/dL, blood glucose \< 85 mg/dL or \> 125 mg/dL, and TSH(thyroid stimulating hormone) \> 4.12 µIU/mL, or other lab test result(s) that would preclude study participation in the judgement of the PI/Sub-I
* Having blood pressure readings at Baseline/screening \> 140 systolic or \> 90 diastolic on two consecutive readings unless permitted to proceed to the next visit in the judgment of the PI/Sub-I
* Currently consumes more than 7 standard alcoholic drinks per week for women and 14 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
* Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges and tangelos
* Having any other circumstance that precludes study participation in the judgment of the PI/Sub-I including use of other nutritional supplements which will be evaluated on a case-by-case basis.

Answer: B