Clinical Trials Directory

Trials / Completed

CompletedNCT02924558

Metabolic Effects of Egg Protein and Unsaturated Fat Intakes in Subjects With Hypertriglyceridemia

Metabolic Effects of Replacing Dietary Refined Carbohydrate With a Combination of Egg Protein and Unsaturated Fats in Men and Women With Elevated Triglycerides

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
28 (actual)
Sponsor
Midwest Center for Metabolic and Cardiovascular Research · Academic / Other
Sex
All
Age
21 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The goal of this study is to evaluate the effects of replacing some refined starches and added sugars with a combination of egg protein and unsaturated fatty acids on markers of cardiometabolic health in men and women with hypertriglyceridemia.

Detailed description

The objective of this study is to evaluate the effects of a combination of egg protein and unsaturated fatty acids acting as substitutes for \~16% of energy from refined carbohydrate on the metabolic profile of men and women with elevated triglycerides. This is a randomized, controlled feeding, crossover trial that includes two screening/baseline visits, two 3-week treatment conditions, and a 2-week washout phase. Subjects consume a standardized background diet (7-day rotating menu) that incorporates at least 3 servings/day of study test foods, providing 40-60% of subjects' daily energy needs. Study test foods consist of yogurt, muffins, waffles, and cookies. The test foods account for 8% higher protein energy (from egg protein) and 8% higher fat energy (from unsaturated fatty acids) in the Active Condition compared to the Control Condition. In the Control Condition, the study foods account for 16% higher carbohydrate energy. The overall macronutrient composition of each condition is as follows: Active Condition, approximately 42/23/35% kcal from carbohydrate/protein/fat, respectively, and Control Condition, approximately 58/15/27% kcal from carbohydrate/protein/fat, respectively. Blood samples will be collected at baseline and end of treatment for measurement of metabolic parameters, and a liquid meal tolerance test (LMTT) will be conducted at baseline and the end of each treatment period.

Conditions

Interventions

TypeNameDescription
OTHEREgg protein/unsaturated fatty acidStudy test foods (yogurt, muffins, waffles, and cookies) containing 8% higher protein energy (egg protein) and 8% higher fat energy (unsaturated fatty acids) than Control
OTHERControlStudy test foods (yogurt, muffins, waffles, and cookies) containing 16% higher carbohydrate energy than Egg protein/unsaturated fatty acid

Timeline

Start date
2015-02-01
Primary completion
2016-02-01
Completion
2016-02-01
First posted
2016-10-05
Last updated
2018-05-15

Source: ClinicalTrials.gov record NCT02924558. Inclusion in this directory is not an endorsement.