Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Change in blood pressure |
Systolic and diastolic blood pressure (mmHg) |
baseline, 4 weeks |
|
| Other |
Change in body weight |
body weight (kg) |
baseline, 4 weeks |
|
| Other |
Change in body composition |
BodPod will be used to measure body fat percentage (body fat %) |
baseline, 4 weeks |
|
| Other |
Change in diet composition |
3-day food logs will be used to record foods and beverages consumed before and during the 28-day intervention period |
baseline, week 2, week 4 |
|
| Other |
Change in fasting and postprandial fatty acid composition |
Fatty acid composition of plasma before and after the high saturated fat meal challenge at pre- and post-intervention visits (% total triglycerides). |
baseline, 4 weeks |
|
| Other |
Change in fasting tocopherol concentrations |
Plasma tocopherol concentrations (ug/ml) |
baseline, 4 weeks |
|
| Other |
Change in anthropometric circumferences |
hip and waist circumferences (cm) |
baseline, 4 weeks |
|
| Other |
Change in resting metabolic rate |
Resting metabolic rate (RMR) will be measured for 30 minutes on the TrueOne 2400 (Parvo Medics, Sandy, UT) |
Screening |
|
| Other |
Change in perceived stress |
Perceived Stress Scale will be administered and scored to determine stress levels |
baseline, 4 weeks |
|
| Other |
Change in anxiety |
The State Trait Anxiety Inventory will be administered and scored to determine anxiety levels. |
baseline, 4 weeks |
|
| Other |
Change in self reported physical activity levels |
The International Physical Activity Questionnaire will be used to collect self-reported average physical activity levels (met/min) |
baseline, 2 weeks, 4 weeks |
|
| Other |
Change in body Mass Index (BMI) |
BMI will be calculated based on height and weight measures (kg/m2) |
baseline, 4 weeks |
|
| Primary |
Change in fasting serum lipoprotein and cholesterol concentrations |
The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein B (mg/dl) |
baseline, 4 weeks |
|
| Primary |
Change in fasting serum lipoprotein particle numbers |
Number of particles of low density lipoproteins (LDL), LDL small, HDL large, LDL medium, lipoprotein (a) (nmol/L) |
baseline, 4 weeks |
|
| Primary |
Change in fasting and postprandial plasma triglyceride concentrations |
The concentration of plasma triglycerides before and after the high saturated fat meal challenge at both pre- and post-intervention visits (mg/dL) |
baseline, 4 weeks |
|
| Primary |
Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations |
The concentration of plasma NEFAs before and after the high saturated fat meal challenge at both pre- and post-intervention visits (mEq/L) |
baseline, 4 weeks |
|
| Primary |
Change in fasting and postprandial plasma glucose concentrations |
The concentration of plasma glucose before and after the high saturated fat meal challenge at both pre- and post-intervention visits (mg/dL) |
baseline, 4 weeks |
|
| Primary |
Change in fasting and postprandial plasma insulin concentrations |
The concentration of plasma insulin before and after the high saturated fat meal challenge at both pre- and post-intervention visits (uU/mL) |
baseline, 4 weeks |
|
| Primary |
Change in fasting and postprandial plasma appetite control hormones concentrations |
The concentration of plasma appetite control hormones before and after the high saturated fat meal challenge at both pre- and post-intervention visits. Appetite control hormones include Cholecystokinin (CCK), Peptide YY (PYY), Ghrelin (pg/mL) |
baseline, 4 weeks |
|
| Primary |
Change in fasting and postprandial subjective feelings related to appetite |
Visual analog scale ratings of feelings related to appetite before and after the high saturated fat meal challenge at both pre- and post-intervention visits. Subjective feelings of hunger, fullness, desire to eat, prospective consumption, and a composite appetite score are measured by visual analog scales (mm). |
baseline, 4 weeks |
|
| Primary |
Change in fasting and postprandial plasma Malondialdehyde (MDA) |
The concentration of MDA before and after the high saturated fat meal challenge at both pre- and post-intervention visits (nmol/mL). |
baseline, 4 weeks |
|
| Primary |
Change in fasting and postprandial plasma total antioxidant capacity |
Total antioxidant capacity before and after the high saturated fat meal challenge at both pre- and post-intervention visits (U/mL). |
baseline, 4 weeks |
|
| Primary |
Change in fasting and postprandial plasma inflammatory cytokine concentrations |
The concentration of interleukin-1 beta, C reactive protein, tumor-necrosis factor-alpha, and interleukin-6 before and after the high saturated fat meal challenge at both pre- and post-intervention visits (pg/mL). |
baseline, 4 weeks |
|
| Primary |
Change in fasting and postprandial plasma markers of coagulation potential |
The concentration of plasminogen activator inhibitor-1, and tissue factor before and after the high saturated fat meal challenge at both pre- and post-intervention visits (pg/mL). |
baseline, 4 weeks |
|
| Primary |
Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins |
The concentration of ANGPTL 3, ANGPTL 4, and ANGPTL 8 before and after the high saturated fat meal challenge at both pre- and post-intervention visits (ng/mL). |
baseline, 4 weeks |
|
| Primary |
Change in fasting insulin resistance metrics |
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment for ß-cell function (HOMA-B) will be calculated from fasting insulin and glucose measures before and after the 28-day intervention. |
baseline, 4 weeks |
|
| Secondary |
Change in fasting serum hepatic enzymes |
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT) (U/L) |
Baseline, 4 weeks |
|
| Secondary |
Change in fasting serum hepatic proteins |
Total protein and albumin (g/dL) |
Baseline, 4 weeks |
|
| Secondary |
Change in fasting serum bilirubin |
Total total bilirubin, direct bilirubin, and indirect bilirubin (mg/dL) |
Baseline, 4 weeks |
|
| Secondary |
Change in additional fasting and postprandial plasma appetite control hormones concentrations |
The concentration of additional plasma appetite control hormones before and after the high saturated fat meal challenge at both pre- and post-intervention visits. Additional appetite control hormones include Glucagon-like peptide-1 (GLP-1), Gastric inhibitory peptide (GIP), Pancreatic Polypeptide (PP) (pg/mL) |
baseline, 4 weeks |
|
| Secondary |
Change in fasting and postprandial plasma antioxidant parameters |
Glutathione peroxidase activity, superoxide dismutase activity, glutathione-s-transferase activity before and after the high saturated fat meal challenge at both pre- and post-intervention visits (U/mL). |
baseline, 4 weeks |
|
| Secondary |
Change in additional fasting and postprandial plasma inflammatory cytokine concentrations |
The concentration of monocyte chemoattractant protein-1, and interleukin-10 before and after the high saturated fat meal challenge at both pre- and post-intervention visits (pg/mL). |
baseline, 4 weeks |
|
| Secondary |
Change in additional fasting and postprandial plasma markers of coagulation potential |
The concentration of Von Willebrand factor, tissue factor pathway inhibitor, fibrinogen and D-dimer before and after the high saturated fat meal challenge at both pre- and post-intervention visits (pg/mL). |
baseline, 4 weeks |
|
| Secondary |
Change in acute dietary intake |
One-day food logs will be used to record all foods and beverages consumed on testing days |
baseline, 4 weeks |
|
