Please select the outcome measures that correspond to the clinical trial below.
Title: Macronutrient Composition of Diet and Risk Factors for Cardiovascular Disease
Brief Summary: The objective of this trial is to examine the long-term effects of a diet low in carbohydrates, as compared to one low in fat, on cardiovascular disease risk factors, including blood pressure (BP), body weight and composition, serum lipids, plasma glucose, insulin, adipocytokines (adiponectin, leptin, resistin), and C-reactive protein (CRP) among obese adults.

The investigators will test the following hypotheses:

Hypothesis 1: Compared to a low fat diet, a diet low in carbohydrates will reduce systolic and diastolic BP over 12 months; Hypothesis 2: Compared to a low fat diet, a diet low in carbohydrates will reduce body weight, total percent body fat, and waist circumference over 12 months; Hypothesis 3: Compared to a low fat diet, a diet low in carbohydrates will reduce serum levels of LDL-cholesterol and triglycerides and increase serum levels of HDL-cholesterol over 12 months; Hypothesis 4: Compared to a low fat diet, a diet low in carbohydrates will reduce plasma levels of glucose and insulin levels over 12 months; and Hypothesis 5: Compared to a low fat diet, a diet low in carbohydrates will reduce plasma levels of leptin, resistin, and CRP and increase plasma levels of adiponectin over 12 months.


Options:
A: weight loss
B: Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group (12 months); Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group (12 Months); Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group (12 months); Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group (12 Months); Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group (12 Months); Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group (12 Months)
C: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)
D: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)

Answer: B