Please select the eligibility criteria that correspond to the clinical trial below.
Title: Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers
Brief Summary: The purpose of the MENU Study is to examine whether there is a differential weight loss response to different dietary macronutrient composition (higher carbohydrate and lower fat versus lower carbohydrate and higher monounsaturated fat \[MUFA\] or lower carbohydrate and walnut-rich higher fat diets) in a weight loss intervention in healthy obese women, depending on insulin resistance status. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.


Options:
A: Inclusion Criteria:

* Men and non-pregnant or sterile women ages 45 and older
* Hypertriglyceridemia
* On statin therapy for at least four weeks
* Either having established cardiovascular disease or at high risk for cardiovascular disease

Exclusion Criteria:

* Severe heart failure
* Any life-threatening disease other than cardiovascular disease
* Active severe liver disease
* Hemoglobin A1c \>10.0%
* Poorly controlled hypertension
* Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure
* Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)
* Known hypersensitivity to the study product, fish and/or shellfish, or placebo
* History of acute or chronic pancreatitis
* Patients are excluded if using the following medications:

  * PCSK9 inhibitors
  * niacin \>200 mg/day or fibrates;
  * any omega-3 fatty acid medications ;
  * dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
  * bile acid sequestrants
B: Inclusion Criteria:

* Age 18- 75 years
* Body Mass Index 25-40
* PHQ-9 score ≥ 5

Exclusion Criteria:

* Current (in past 6 months) clinical Major Depressive Disorder Episode (according to psychiatric DSM-IV criteria as determined with The Mini-International Neuropsychiatric Interview 5.0 (M.I.N.I. 5.0)
* Current (in past 6 months) use of antidepressant drugs or psychological interventions.
* History of psychosis, bipolar disorder, substance dependence or other severe, psychiatric disorder that requires specialized clinical attention. No eating disorders. This will all be measured with a brief self-report questionnaire.
* History of bariatric surgery and no current severe, life-threatening disease (assessed using self-report), and no severe cognitive impairment limiting the conduct of the study, as assessed through research staff- evaluation of feasibility of conducting the screening instruments in an adequate manner.
* Currently adhering to supervised behavioural interventions that intervene with MoodFood interventions. If persons are on specific dietary supplements that are competing with the MoodFood intervention, than persons must be willing to stop what they were using before the start of this study
* Non pregnant or breast feeding
C: Inclusion Criteria:

* Aged 21 years and older
* Have BMI \>30.0 kg/m2 and \<40 kg/m2
* Willing and able to participate in clinic visits, group sessions, and telephone and Internet communications at specified intervals
* Able to provide data through questionnaires and by telephone
* Willing to maintain contact with the investigators for 12 months
* Willing to allow blood collections
* No known allergy to tree nuts
* Able to be physically active

Exclusion Criteria:

* Diabetic
* Inability to be moderately physically active
* A history or presence of a comorbid diseases for which diet modification and increased physical activity may be contraindicated
* Currently pregnant/breastfeeding
* Planning to become pregnant within the next year
* Currently enrolled in a weight loss program or diet intervention study
* Current use of weight loss medication or supplements
* Planned surgical procedure that can impact the conduct of the study
* Have plans to relocate from area within the next year
* 6+ months use of meds likely to cause weight gain or prevent weight loss
* Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
D: Inclusion Criteria:

* Greater than or equal to 2 of the following 4 signs in the same eye at screening and baseline visits (Same signs must be present at Screening and Baseline visits): Conjunctival staining present greater than or equal to 1 (out of possible score of 6 per eye), Corneal fluorescein staining present greater than or equal to 4 (out of a possible score of 15 per eye), Tear film break up time (TBUT) less than or equal to 7 seconds, Schirmer's test greater than or equal to 1 to less than or equal to 7 mm in 5 minutes.
* Ocular Surface Disease Index (OSDI) score: 25-80 at screening, 21-80 at baseline.
* Symptoms of DED for greater than or equal to 6 months.
* Use of or desire to use artificial tears at least 2 times per day in preceding 2 weeks.
* Ability to swallow large, soft gelcaps

Exclusion Criteria:

* Allergic to ingredients in supplements or placebo
* Contact lens wear
* Pregnant, nursing, or lactating
* Current ocular infection, inflammation, or acute allergic conjunctivitis
* History of: ocular herpetic keratitis, ocular surgery in past 6 months, LASIK surgery, use of glaucoma medicine or surgery for glaucoma, liver disease, atrial fibrillation, hemophilia or bleeding tendencies
* Currently on anticoagulation therapy
* Eyelid abnormalities or extensive ocular scarring
* Use of EPA/DHA supplements in excess of 1200 mg per dayi
* Current use, insufficient washout period, or intent to change specific treatments for dry eye disease

Answer: C