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

NCT02924558 | Completed

• 1 other identifier: MC-1412
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypertriglyceridemia

Keywords

Egg; Protein; Unsaturated fatty acids; Triglycerides; Insulin sensitivity; Lipid triad

Outcome Measures

Primary Outcomes (1)

• Matsuda composite index of insulin sensitivity (MISI)

  Difference between treatments in percent change from baseline to end of treatment MISI calculated from glucose and insulin responses to the LMTT at Visit 2, Day 0 (baseline); Visit 6, Day 21 (end of treatment period I); and Visit 11, Day 21 (end of treatment period II)

  3 weeks

Secondary Outcomes (7)

• Lipoprotein lipids

  3 weeks

• Lipoprotein particle concentrations

  3 weeks

• Apolipoprotein (Apo) B

  3 weeks

• Homeostasis model assessment of insulin sensitivity (HOMA2-%S)

  3 weeks

• LMTT disposition index

  3 weeks

Study Arms (2)

Egg protein/unsaturated fatty acid

EXPERIMENTAL

8% higher protein energy (from egg protein) and 8% higher fat energy (from unsaturated fatty acids); approximately 42/23/35% kcal from carbohydrate/protein/fat, respectively

Other: Egg protein/unsaturated fatty acid

Control

PLACEBO COMPARATOR

16% higher carbohydrate energy; approximately 58/15/27% kcal from carbohydrate/protein/fat, respectively

Other: Control

Interventions

Egg protein/unsaturated fatty acid OTHER

Study test foods (yogurt, muffins, waffles, and cookies) containing 8% higher protein energy (egg protein) and 8% higher fat energy (unsaturated fatty acids) than Control

Egg protein/unsaturated fatty acid

Control OTHER

Study test foods (yogurt, muffins, waffles, and cookies) containing 16% higher carbohydrate energy than Egg protein/unsaturated fatty acid

Control

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fasting TG level 150-499 mg/dL
• Body mass index (BMI) 25.0-39.9 kg/m2
• Score of 7-10 on Vein Access Scale
• Normally active and judged to be in general good health on basis of medical history and routine laboratory tests

You may not qualify if:

• Fasting blood glucose ≥126 mg/dL or known type 1 or type 2 diabetes mellitus
• Atherosclerotic cardiovascular disease
• Recent history or current significant renal, pulmonary, hepatic, biliary, or gastrointestinal disease
• Abnormal lab test results of clinical significance (e.g., creatinine ≥1.5 mg/dL and aspartate or alanine transaminase ≥1.5 times upper limit of normal)
• History of cancer in previous 2 years
• Uncontrolled hypertension
• Recent unstable use of anti-hypertensive medication, thyroid hormone replacements, and/or medications known to substantially influence carbohydrate metabolism
• Recent use of certain blood pressure medications (e.g., beta-adrenergic blockers and/or high-dose thiazide diuretics)
• Recent use of lipid-altering drugs (e.g., statins, bile acid sequestrants, cholesterol absorption inhibitors, or fibrates)
• Recent use of diabetes medication (e.g., alpha-glucosidase inhibitors, biguanides and biguanide combinations, bile acid sequestrants, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, meglitinides, and sulfonylureas and combination sulfonylureas)
• Recent use of lipid-altering foods, herbs, or dietary supplements (e.g., niacin, sterol/stanol products, dietary fiber supplements, red rice yeast supplements)
• Recent unstable use of herbs and dietary supplements that may influence carbohdyrate metabolism
• Extreme dietary habits, dietary restrictions, or significant food allergies
• Required energy intake \<2200 kcal/day or \>3400 kcal/day
• Recent change in body weight of ±4.5 kg

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• American Egg Board: collaborator
• Egg Nutrition Center: collaborator

Related Publications (1)

• Maki KC, Palacios OM, Lindner E, Nieman KM, Bell M, Sorce J. Replacement of Refined Starches and Added Sugars with Egg Protein and Unsaturated Fats Increases Insulin Sensitivity and Lowers Triglycerides in Overweight or Obese Adults with Elevated Triglycerides. J Nutr. 2017 Jul;147(7):1267-1274. doi: 10.3945/jn.117.248641. Epub 2017 May 17.

  PMID: 28515160 DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia; Insulin Resistance

Interventions

Egg Proteins; Fatty Acids, Unsaturated

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Fatty Acids; Lipids

Study Officials

• Kevin C Maki, PhD

  Midwest Center for Metabolic and Cardiovascular Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 5, 2016
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share