Please select the eligibility criteria that correspond to the clinical trial below.
Title: Do Insulin Secretion or Genotype Pattern Predict Low Fat vs Low Carb Weight Loss Success?
Brief Summary: Genomics research is advancing rapidly, and links between genes and obesity continue to be discovered and better defined. A growing number of single nucleotide polymorphisms (SNPs) in multiple genes have been shown to alter an individual's response to dietary macronutrient composition. Based on prior genetic studies evaluating the body's physiological responses to dietary carbohydrates or fats, the investigators identified multi-locus genotype patterns with SNPs from three genes (FABP2, PPARG, and ADRB2): a low carbohydrate-responsive genotype (LCG) and a low fat-responsive genotype (LFG). In a preliminary, retrospective study (using the A TO Z weight loss study data), the investigators observed a 3-fold difference in 12-month weight loss for initially overweight women who were determined to have been appropriately matched vs. mismatched to a low carbohydrate (Low Carb) or low fat (Low Fat) diet based on their multi-locus genotype pattern. The primary objective of this study is to confirm and expand on the preliminary results and determine if weight loss success can be increased if the dietary approach (Low Carb vs. Low Fat) is appropriately matched to an individual' s genetic predisposition (Low Carb Genotype vs. Low Fat Genotype) toward those diets.


Options:
A: Inclusion Criteria:

* SBP of 120 to 159 mmHg and DBP less than 100 mmHg at study entry (mean over three screening visits) (note: participants with stage 2 hypertension \[SBP greater than 160 mmHg or DBP greater than 100 mmHg\] based on the mean over three screening visits will be excluded, as will participants with a mean SBP greater than 170 mmHg or DBP greater than 105 mmHg at any one visit)
* Overweight or obese, as defined by a body mass index (BMI) greater than 25 kg/m2
* Willing to eat at least one on-site meal per day, 5 days per week, and willing to eat study diets and nothing else during controlled feeding periods

Medication Exclusion Criteria:

* Symptomatic ischemic heart disease (e.g., angina pectoris)
* Regular use of medications that raise or lower BP during the 2 months prior to study entry
* Use of a lipid lowering agent in the 3 weeks prior to study entry
* Unstable dose of hormone replacement therapy, thyroid hormone replacement therapy, and psychotropic medications known to cause weight gain or affect the outcome variables (unstable is defined as a change in dose within 2 months of study entry)
* Use of insulin, oral hypoglycemic agent, lithium, oral corticosteroid, anti-psychotic drugs, weight loss medications, nitrate, or digitalis

Medical History Exclusion Criteria:

* Active or prior CVD (e.g., stroke, heart attack, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, congestive heart failure, symptomatic ischemic heart disease \[angina\], or arteriosclerotic cardiovascular disease-related therapeutic procedure)
* Diabetes mellitus
* Cancer diagnosis or treatment in the 2 years prior to study entry (note: people with non-melanoma skin cancer, localized breast cancer, or localized prostate cancer can enroll if they did not require systemic chemotherapy)
* Active inflammatory bowel disease, malabsorption, or major gastrointestinal resection
* Renal insufficiency as determined by a serum creatinine greater than 1.2 mg/dL for women or greater than 1.4 mg/dL for men (these participants can enroll if their estimated glomerular filtration rate is greater than 40 mL/min by either the Cockcroft-Gault equation or the simplified Modification of Diet in Renal Disease equation)
* Emergency room visit or hospital stay for asthma or chronic obstructive pulmonary disease in the 6 months prior to study entry
* Any serious illness not otherwise specified that would interfere with participation

Laboratory Exclusion Criteria:

* Fasting LDL cholesterol greater than 220 mg/dL and triglycerides greater than 750 mg/dL
* Fasting blood glucose greater than 125 mg/dL
* Serum transaminase greater than 2 times the upper range of normal, or a clinical diagnosis of hepatitis
B: Inclusion Criteria:

* 18-35 years of age
* Intending to be available for a 24 month intervention
* An active cellular telephone that is capable of receiving text messaging
* A computer and internet connectivity that can be used for the BodyMedia Fit system
* Body mass index (BMI) between 25.0-39.9 kg/m2
* The ability to provide medical clearance to participate in this study from their primary care physician
* The ability to complete the baseline graded exercise test, and clearance from the study physician to participate in this study after reviewing the results from this study

Exclusion Criteria:

* Unable to provide informed consent
* Household member on study staff
* Past or planned (within the next 24 months) weight loss surgery (e.g. gastric bypass, lap band, or liposuction); current participation in a commercial weight loss program (e.g. Weight Watcher's, Jenny Craig); current or planned enrollment in another diet/PA/weight loss intervention study
* Report regular use of systemic steroids, prescription weight loss drugs. "Regular use" is defined as "taking this medication most days of the week for the previous month"
* Current treatment for eating disorder
* Cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months
* Current treatment for malignancy (other than non-melanoma skin cancer)
* Currently pregnant or gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, actively planning pregnancy within the next 24 months
* Investigator discretion
* Currently taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers)
* Report losing \>5% of current body weight in the previous 6 months
* Currently treated for psychological issues, or taking psychotropic medications within the previous 6 months
* Report taking medication that could affect metabolism or change body weight
* Current treatment for diabetes mellitus
C: Inclusion Criteria

* Body mass index (BMI) between 27 and 40 kg/m2
* Weight stable for last 2 months
* Not actively on a weight loss plan
* No plans to move from the area over the next 2 years
* Willing to accept random assignment

Exclusion Criteria

* Pregnant or breastfeeding
* Within 6 months of giving birth or planning to become pregnant in the next 2 years
* Diabetes (type 1 or 2) or history of gestational diabetes
* Renal or liver disease, active neoplasms, or recent myocardial infarction
* Hyper- or hypothyroidism
* Lipid lowering medications or medications known to affect weight/energy expenditure
* Excessive alcohol intake (self-reported, \> 3 drinks/day)
* Postmenopausal, including surgical menopause
* Currently under psychiatric care or severely clinically depressed (\> 17 on Beck Inventory)
D: Inclusion Criteria:

* Age: \> 18 years of age
* Women: Pre-menopausal (self-report) and \<50 years of age
* Men: \<50 years of age
* BMI (body mass index): 27-40 kg/m2 (need to lose \>10% body weight to achieve healthy BMI)
* Body weight stable for the last two months, and not actively on a weight loss plan
* No plans to move from the area over the next two years
* Available and able to participate in the evaluations and intervention for the study period
* Willing to accept random assignment
* To enhance study generalizability, people on medications not noted below as specific exclusions can
* participate if they have been stable on such medications for at least three months
* Ability and willingness to give written informed
* No known active psychiatric illness

Exclusion Criteria:

Subjects with the following conditions will be excluded (determined by self-report):

* Pregnant, lactating, within 6 months post-partum, or planning to become pregnant in the next 2 years
* Diabetes (type 1 and 2) or history of gestational diabetes or on hypoglycemic medications for any other indication
* Prevalent diseases: Malabsorption, renal or liver disease, active neoplasms, recent myocardial infarction (\<6 months)(patient self-report and, if available, review of labs from primary care provider)
* Smokers (because of effect on weight and lipids)
* History of serious arrhythmias, or cerebrovascular disease
* Uncontrolled hyper- or hypothyroidism (TSH not within normal limits)
* Medications: Lipid lowering, antihypertensive medications, and those known to affect weight/energy expenditure
* Excessive alcohol intake (self-reported, \>3 drinks/day)
* Musculoskeletal disorders precluding regular physical activity
* Unable to follow either of the two study diets for reasons of food allergies or other (e.g., vegan)
* Currently under psychiatric care, or taking psychiatric medications
* Inability to communicate effectively with study personnel

Answer: D