Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain in Overweight But Generally Healthy Adults Over the Winter Holiday Period
Brief Summary: The purpose of this study is to assess the effects of repeated periods of modified fasting in support of healthy weight management and prevention of weight gain over the winter holiday period (mid-November to early January) in comparison to regular diet and activity.


Options:
A: Inclusion Criteria:

* Men and women
* Age 30-70 years
* Language: English or Spanish
* At least 3 features of the NCEP ATP-III metabolic syndrome

Exclusion Criteria:

* Diabetes
* Established CVD
* Uncontrolled hypertension (systolic BP \>160 and diastolic BP \>100 mm Hg)
* Established liver disease
* Renal insufficiency
* Psychiatric illness
* Chronic substance abuse within the past 5 years
* Chronic obstructive pulmonary disease or severe asthma.
B: 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.
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:

* 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: D