Please select the eligibility criteria that correspond to the clinical trial below.
Title: Healthy Nutrition and Energy Restriction as Cancer Prevention Strategies: a Randomized Controlled Intervention Trial
Brief Summary: This study evaluates the effect of intermittent calorie restriction versus continued calorie restriction on weight loss, gene expression profile of subcutaneous adipose tissue and abdominal fat distribution.


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:

* Are a new patient at the UAB Weight Loss Medicine Clinic
* Aged 25-75 years old
* BMI between 30-60 kg/m2 (inclusive)
* Weigh less than 450 lbs
* Wake up regularly between 4-9 am on most days.

Exclusion Criteria:

* Diagnosed with diabetes, have an HbA1c of ≥6.5%, or are on diabetes medication
* On weight loss medication
* Addition of or withdrawal from a chronic medication within the past 10 weeks
* Clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
* Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
* Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity
* Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
* Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)
* Lost or gained more than 5 lbs of weight in the past month
* Currently perform overnight shift work more than once per week on average
* Regularly eat within a less than 10-hour period each day
* Regularly eat dinner before 6 pm
* Traveled more than two time zones away in the two months prior to enrolling in the trial
* Will travel more than one time zone away during the study
* Pregnant or breastfeeding
C: Inclusion Criteria:

* Age ≥ 18 years
* BMI≥24kg/m2
* Polycystic ovary syndrome has been diagnosed

Exclusion Criteria:

* Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
* The body weight fluctuated more than 5% in recent 3 months.
* Liver and kidney dysfunction: renal impairment, creatinine clearance rate \< 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit;
* History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
* History of thyroid diseases;
* Having been in pregnancy.
* Researchers believe that there are any factors that affect assessing subjects' participation in trial.
* History of malignant tumors;
* History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
* Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight)
* Patients who cannot be followed for 16 months (due to a health situation or migration)
* Patients who are unwilling or unable to give informed consent.
D: Inclusion Criteria:

* Women and men aged 35 to 65 years
* Overweight or obese (BMI ≥ 25 kg/m2 ≤ 40 kg/m2 )
* German speaking
* Non- smoker
* Provision of written informed consent

Exclusion Criteria:

* Not able to understand and sign the informed consent form in person
* Already diagnosed diabetes
* HbA1c ≥ 6.5 % and/or fasting plasma glucose \> 125 mg/dl
* History of cancer within the past 10 years
* Risk of bleeding disorders (e.g. Marcumar intake)
* Current or history of eating disorders (bulimia, anorexia, binge-eating)
* Pregnant or lactating during the past 12 months
* Increased or decreased thyroid-stimulating hormone in baseline blood check
* Already diagnosed hepatic dysfunction and/or increased or decreased γ-GT, GPT and/or GOT in baseline blood check
* Already diagnosed kidney dysfunction and/or increased or decreased creatinine, urea and/or uric acid in baseline blood check
* Medications that might affect the endpoints of the study e.g. immunosuppressive medication (cortisol, antibody treatment), hormone replacement therapy, medication for fat metabolism (e.g. statine, fibrate)
* Participation in another intervention study shorter than three months ago

Answer: D