AzTrials
AzTrials

HypertriglyceridemiaNCT02924558

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

A study testing Egg protein/unsaturated fatty acid in people with Hypertriglyceridemia, run by Midwest Center for Metabolic and Cardiovascular Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Hypertriglyceridemia
What is being tested?
Egg protein/unsaturated fatty acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
No sites listed yet
Study dates
Feb 2015to Feb 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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
  • Recent use of weight loss drugs or programs
  • Active infection or on antibiotic therapy
  • Current or recent history of drug or alcohol abuse
  • Pregnant, planning to be pregnant, or lactating females or women of childbearing potential unwilling to commit to use of a medically approved form of contraception

About this study

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

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.

Read the 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.

Being tested
Egg protein/unsaturated fatty acid, Control
Keywords
Egg, Protein, Unsaturated fatty acids, Triglycerides, Insulin sensitivity, Lipid triad
Medical subject headings
Hypertriglyceridemia, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Egg protein/unsaturated fatty acidOther

    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

  • ControlOther

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

Study groups in NCT02924558
Study groupRoleWhat they receive
Egg protein/unsaturated fatty acidExperimental8% 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
Receives: Other: Egg protein/unsaturated fatty acid
ControlPlacebo comparator16% higher carbohydrate energy; approximately 58/15/27% kcal from carbohydrate/protein/fat, respectively
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 weeks

Secondary outcomes (7)

  1. Lipoprotein lipids

    Difference between treatments in percent change from baseline to end of treatment fasting triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), low-density lipoprotein cholesterol (LDL-C), and TC/HDL-C ratio based on the average of values collected at Visits 1 and 2, Days -7 and 0 (baseline); Visits 5 and 6, Days 19 and 21 (end of treatment period I); and Visits 10 and 11, Days 19 and 21 (end of treatment period II)

    Measured: 3 weeks

  2. Lipoprotein particle concentrations

    Difference between treatments in change from baseline to end of treatment lipoprotein particle subclass concentrations and sizes, as well as cholesterol carried by major lipoproteins and subfractions analyzed using an ion mobility assay at Visit 2, Day 0 (baseline); Visit 6, Day 21 (end of treatment period I); and Visit 11, Day 21 (end of treatment of period II)

    Measured: 3 weeks

  3. Apolipoprotein (Apo) B

    Difference between treatments in percent change from baseline to end of treatment apo B 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)

    Measured: 3 weeks

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

    Difference between treatments in change from baseline to end of treatment HOMA2-%S calculated from fasting values of insulin and glucose 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)

    Measured: 3 weeks

  5. LMTT disposition index

    Difference between treatments in the percent change from baseline to end of treatment LMTT disposition index calculated from insulin and glucose responses during 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)

    Measured: 3 weeks

  6. Homeostasis model assessment of pancreatic beta-cell function (HOMA2%B)

    Difference between treatments in change from baseline to end of treatment HOMA2%B calculated from fasting insulin and glucose values 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)

    Measured: 3 weeks

  7. Blood pressure

    Difference between treatments in change from baseline to end of treatment in systolic and diastolic blood pressures based on the average of values collected at Visits 1and 2, Days -7 and 0 (baseline); Visits 5 and 6, Days 19 and 21 (end of treatment period I); and Visits 10 and 11, Days 19 and 21 (end of treatment period II)

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2016 (estimated)
  2. Study startFeb 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02924558
Sponsor's protocol ID
MC-1412
Status last verified
May 2018
First submitted
3 Oct 2016
Last updated
15 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28515160

Questions about this trial

What is this clinical trial studying?

A study testing Egg protein/unsaturated fatty acid in people with Hypertriglyceridemia, run by Midwest Center for Metabolic and Cardiovascular Research.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Matsuda composite index of insulin sensitivity (MISI) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02924558, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in