Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Carbohydrate Containing Diets on Lipid Metabolism & Fatty Acid Oxidation in Healthy Young Men - a Randomized, Double-Blinded Study.
Brief Summary: The objective of this study is to investigate the impact of sugar sweetened beverages on the fat metabolism of healthy young men. It is well known that consumption of beverages sweetened with fructose is associated with different health risks such as type 2 diabetes. The present study has been designed to dissect differences in the metabolic pathways of fructose and glucose, but also metabolic adaptations during fructose, glucose and sucrose diets. During a period of seven weeks subjects will consume either fructose, glucose or sucrose sweetened beverages or continue their usual drinking habits. During these seven weeks there will be different metabolic investigations using stable isotope tracers. First, the rate of lipolysis and beta-oxidation will be determined. Second, the rates of fatty acid synthesis will be measured. During all examinations there will also be substrate- and energy-utilization measurements by indirect calorimetry, blood analysis and morphometric measurements. Based on the literature main hypotheses are: Fructose enhances de novo lipogenesis postprandially and also in the fasting state significantly more than glucose by enhanced expression of lipogenic enzymes. Fructose decreases beta oxidation via downregulation of oxidative enzymes.


Options:
A: Inclusion criteria:

* Healthy male volunteers aged 20-50y with a BMI between 19 and 25 kg/m2

Exclusion criteria:

* Acute infection, malignant disease, renal (abnormal creatinine), hepatic (more than two-fold increased transaminases), pulmonary, neurological (epilepsy) or major psychiatric diseases, manifested atherosclerosis
* Fasting plasma glucose \> 5.6 mmol/l
* Known alcohol or drug abuse
* HIV-antibody positive
* Subjects likely to fail to comply with the study protocol
* Smoking (\>1 cigarette/month)
* Subjects who do not give informed consent

Additional exclusion criteria after baseline measurements:

* Subjects with high baseline consumption of soft drinks (\>60g of carbohydrates daily)
B: Inclusion Criteria:

* 18-65 years of age.
* Body mass index (BMI) between 25.0-49.9 kg/m2.
* Subject consumes at least 280 calories per day from caloric beverages.

Exclusion Criteria:

* Report losing \>5% of current body weight in the previous 6 months.
* Report participating in a research project involving weight loss or physical activity in the previous 6 months, as these proximal experiences may impact the results of this study. Additionally, report current participating in any other research studies whose results could be compromised by or in which participation could compromise this research study. (Participation in a research study that would not affect or be affected by this study is allowed.)
* Report pregnancy or lactation during the previous 6 months, or planned pregnancy in the next 6 months.
* Report taking medication that could affect metabolism or change body weight (e.g., synthroid).
* Report hospitalization for psychiatric problems during the prior year.
* Report major psychiatric diagnoses and organic brain syndromes.
* Report heart problems, chest pain, cancer within the last 5 years
* Being treated by a therapist for psychological issues or problems with psychotropic medications.
* Report behaviors that indicate probable alcohol dependence as assessed by the Rapid Alcohol Problems Screen (RAPS4-QF) (Cherpitel CJ, 2002).
* Unwilling to change intake of beverages during the study period.
* Plan to move from the area during the study period, and/or unable to attend monthly group meetings.
* Report not having adequate transportation to the study center that would allow transport of study supplies back to the subject's home.
* Report not being able to attend group meetings on Monday or Tuesday evenings.
C: Inclusion criteria:

* Healthy male volunteers aged 18-30
* BMI between 19-24 kg/m2
* Non-smoker

Exclusion criteria:

* Acute or chronic infections, malignant disease, renal, hepatic (more than two-fold increased transaminases), pulmonary, neurological (epilepsy) or psychiatric diseases, manifested atherosclerosis, or any other disease precluding participation in the study.
* Diabetes
* Known alcohol, substance or drug abuse, concomitant medication
* More than three hours of physical exercise per week
* Consumption of more than 2 times 3 dl SSB daily
* Subjects likely to fail to comply with the study protocol
* Subjects who do not give informed consent
D: Inclusion Criteria:

1. Are generally healthy men and women older than 18 years of age.
2. Are willing and able to undergo the informed consent process.
3. Have body mass index (BMI) from 25.0 to 34.9 kg/m².
4. Have one or more fasting plasma or serum glucose values of 90-150 mg/dl documented within 4 weeks of the initial study visit, or upon safety lab evaluation at the initial study visit.
5. Have blood pressure \> 120 mmHg systolic or \> 80 mmHg diastolic.
6. Are willing to notify the research staff of any change in their medical health \& concomitant medications/supplements during the course of the clinical trial.

Exclusion Criteria:

1. Intolerance, dislike, or unwillingness to consume raisins or any of the comparator snacks and affiliated ingredients.
2. History of \> one "food allergy."
3. Weight loss of \> 5 pounds in last 2 months
4. Prior diagnosis of diabetes mellitus or currently taking diabetes mellitus drugs (including drugs such as metformin and colesevelam HCl, even if not being taken for diabetes mellitus). Subjects with prior history of gestational diabetes mellitus are eligible, as long as they no longer have diabetes mellitus, and are no longer taking medications for diabetes mellitus.
5. Blood pressure \>160 mmHg systolic or \>100 mmHg diastolic.
6. Fasting serum lipoprotein values of: LDL-cholesterol, \>160 mg/dl or triglycerides, \>500 mg/dl.
7. Creatinine level \> 1.5 times the upper range of normal.
8. Potassium level above the upper range of normal (one repeat lab would be permitted if the initial elevated potassium level is thought possibly due to laboratory error)
9. Use of any medication or supplement to treat diabetes mellitus or blood glucose management at, or within 2 months prior to initial study entry.
10. Initiation or change of any antihypertensive medication within the two months prior to initial study entry. Subjects would be eligible if on stable dose of one or two antihypertensive medications that is/are to be maintained at constant dose throughout the study.
11. Initiation or change of any lipid-altering drug within the two months prior to initial study entry. Subjects would be eligible if on stable dose of one or two lipid-altering drugs that is/are to be maintained at constant dose throughout the study.
12. Is pregnant, breastfeeding or plans to become pregnant during the next three months.
13. Is an employee or immediate family member of the research staff.
14. Donated blood within 2 months prior to study entry, or plans to donate blood during the course of this study.
15. Use of systemic corticosteroids (intravenous, subcutaneous, intra-articular). Inhaled and intranasal corticosteroids are permitted.
16. Use of antiobesity/weight maintenance drug therapies at initial study visit, or within 2 months of the initial study visit.
17. Known medical history of clinical significance, or any other conditions that would present unacceptable risk to study subject, compromise the acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study as per discretion of the Principal Investigator.
18. History of severe or uncontrolled depression based on Principal Investigator.
19. Known laboratory abnormalities prior to randomization which Principal Investigator deems may pose an unacceptable risk, compromise acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study.
20. Major surgical procedure within 30 days prior to visit #1 (i.e. day of signing of the informed consent document), or current plans to have a major surgical procedure during study participation or 30 days following completion of all study related procedures.
21. History of gastrointestinal malabsorption (e.g. uncontrolled crohn's disease, etc.) or history of a gastric bypass or other diversional bariatric surgery. Gastric banding procedure is also exclusionary if adjusted within 30 days prior to visit #1 (i.e. day of signing the informed consent document), or a reasonable chance of having a gastric banding adjustment during the course of the study.
22. History of ongoing malignancy. Malignancy that has been successfully treated, with no evidence of persistence or recurrence of the malignancy within 5 years of visit #1 (i.e. day of signing the informed consent document) or basal carcinoma of the skin and "in situ" cancer of the cervix successfully treated 30 days prior to visit #1 are acceptable.
23. History of organ transplant.
24. History of drug (licit or illicit) or alcohol abuse/addiction within 5 years of visit #1 (i.e. day of signing the informed consent document).
25. Consumes more than 2 units of alcohol per day. A unit of alcohol is defined as a 12 ounce (350 ml) beer, 5 ounce (150 ml) wine, or 1.5 ounce (45 ml) of 80-proof alcohol for mixed drinks.
26. Known positive testing for hepatitis B surface antigen, hepatitis C antibody, active hepatitis A immunoglobulin M, or human immunodeficiency virus.
27. Anticipation of a significant change in job, job duties, or job work hours, which might impair their ability and willingness to undergo study-related procedures under the timelines specified by protocol, and otherwise impede their completion of the study.
28. Anticipation of or a reasonable likelihood of moving away from the research site, wherein such a move might impair their ability and willingness to undergo study-related procedures within the timelines specified by protocol, or otherwise impede their completion of the study.
29. Anticipation of or a reasonable likelihood of vacations or other times away from home which might impair their ability and willingness to undergo study-related procedures within the timelines specified by the study protocol, or otherwise impede their completion of the study.
30. Planned or anticipated major changes in lifestyle health practices, unless allowed by study protocol. Therapeutic Lifestyle Changes counseling will take place at randomization.
31. Treatment with an investigational product or an investigational device within 30 days prior to visit #1 (i.e. day of signing the informed consent document) and have no plans to potentially start any investigational product or use an investigational device during or 30 days after the study subject completes all study related procedures.
32. Reasonable life-expectancy of less than 2 years.
33. Any other reason, if in the opinion of the Investigator, the individual study subject is not appropriate, or suitable for participation in the clinical trial.

Answer: C