Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Carbonated Soft Drinks on Body Weight, Fat Distribution and Metabolic Risk Factors
Brief Summary: Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation leading to obesity development. Although drinks sweetened with aspartame are available the anticipated positive effect of these drinks on obesity development has not been convincing. However, the mechanisms linking drinks intake to obesity are yet to be clarified.

The investigators aim is to investigate the long-term effects of intake of soft drinks, milk and water. The study is a parallel, intervention trial with 80 overweight, healthy volunteers. They will be randomly selected to drink one liter a day of one of the four drinks for six months. The objectives are changes in numerous circulating metabolic risk factors, changes in body weight, anthropometric data and fat distribution (measured by DEXA, MRI and MR-spectroscopy).

The investigators expect to clarify the mechanisms linking drinking habits to obesity development and provide scientifically based nutritional guidelines.


Options:
A: Inclusion Criteria:

* BMI ≥ 27.0 and ≤ 35.0 kg/m2
* Healthy
* Age between 18 and 65 years (inclusive)
* Regular consumer of cold NNS or water beverages (\>3 per week but \< 2 litres per day)
* Acceptance of randomization to either a water or NNS beverage condition
* Willing to abstain from consuming NNS beverages (if randomized to the water condition) and SSBs for the duration of the trial.
* Provided voluntary written informed consent
* Not planning on moving outside of the local area in the next 24 months
* Two individuals from the same household complying with the inclusion and exclusion criteria will be permitted to participate in the trial however, in such instances, the individuals will be randomized to the same group

Exclusion Criteria:

* Not willing to discontinue drinking NNS beverages for the duration of the trial should they be assigned to the water group and vice versa;
* Not willing to consume NNS beverages or water for the duration of the trial;
* Expressing a significant dislike of NNS beverages (at least moderately likeable on a 5 point likert scale);
* Excess consumer of chilled beverages or NNS beverages (more than 2 litres a day);
* A BMI below 27 or above 35 kg/m2;
* Below the age of 18 or above 65 years;
* A first year University Student (to avoid the 'freshman 15' phenomenon of weight gain within the first year of attending University);
* Significant health problems (including a history of cardiovascular diseases);
* Gastro-intestinal problems or diabetes;
* Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study;
* Stated major psychiatric disorder (made clear by medicines specified);
* Current depression (made clear by medicines specified);
* Currently being treated for a psychological condition;
* Being pregnant, planning to become pregnant, breastfeeding or less than 6 months post-partum;
* Planning on moving away from the local area within the next two years;
* History of anaphylaxis to food; known food allergies or food intolerance;
* Dislike of \> 25% of the study foods offered on the appetite probe day (Subset 1 only);
* Non breakfast eaters (subset 1 only);
* Smoking or having ceased smoking in the last six months;
* Currently dieting, having ceased a diet in less than 4 weeks, or having lost significant amounts of weight in the previous year;
* Engaging in regular intense exercise;
* Having significantly changed their physical activity patterns in the past 4 weeks or intending to change them during the study (other than to adhered to advice given in the behavioural intervention);
* Inability to adhere to the programme such as inability to increase activity level;
* Receiving systemic or local treatment likely to interfere with evaluation of the study parameters;
* Working in appetite or feeding-related disciplines;
* Being on specific food avoidance diets;
* Having had bariatric surgery;
* Having abnormal eating behaviour (restrained eaters measured by the Dutch Eating Behaviour Questionnaire - Restraint Scale \[DEBQ-R\] with a cut-off point of more than 4 (van Strien et al,1986); and binge eaters measured by the Binge Eating Scale with a cut-off point of 27 or over (Gormally et al, 1982))
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:

* Age between 20-50 years;
* BMI between 28-36 kg/m2;
* Weight stabile 3 months prior to the study inclusion;
* Less than 10 hours of weekly exercise

Exclusion Criteria:

* Diabetes
* Allergic to phenylalanine or milk
* Smoking
* Pregnancy or breast-feeding
D: Inclusion Criteria:

* Body Mass Index: 27 - 40 kg/m2
* Must drink no calorie, sweetened drinks

Exclusion Criteria

* Cardiovascular disease
* Uncontrolled blood pressure
* Smoker
* Medications that affecting metabolism
* Oral steroids
* History of stroke or seizures
* Thyroid disease
* Type 1 or 2 diabetes
* Cushings syndrome
* Renal disease
* Liver disease
* Cancer in the past 5 years
* HIV
* Active tuberculosis
* Major psychiatric disorders

Answer: C