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Completed

NCT Number: NCT02529709

The Effect of Meal Composition on Blood Lipids

The purpose of this study is to see if a high-protein meal leads to a better postprandial (after a meal) blood lipid profile compared to a high-monounsaturated meal.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Christian University

Fort Worth, Texas, 76129, United States

About this study

The effect of a high-protein diet compared to a high-monounsaturated fat diet on fasting lipids is controversial (1,2), In addition, these studies did not examine the effect of a high-protein compared to a high-monounsaturated meal on postprandial lipid concentrations. Postprandial lipid responses are important to examine since they are associated with heart disease (3,4). In addition, most individuals in Western countries are in a postprandial state for majority of the day. The present study will compare the effect of a high-protein meal versus a high-monounsaturated fat meal on postprandial lipid responses.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women ages 18-65 years.

Exclusion criteria

  • Use of medications or supplements that affect lipid levels, body weight, or blood glucose,
  • following a weight loss diet,
  • being a vegan,
  • smoking,
  • heavy alcohol use,
  • pregnancy,
  • lactation,
  • severe depression,
  • eating disorders,
  • presence of liver, kidney, gastrointestinal, adrenal, or untreated thyroid disease,
  • diabetes,
  • lactose intolerance,
  • documented mal-absorption, or
  • bowel surgery that affects absorption.

Treatment and study plan

High-Protein Condition

Other

The participants will be fed a high-protein meal

High-Monounsaturated Fat Condition

Other

The participants will be fed a high-monounsaturated fat meal

Primary outcomes

  1. Blood lipid concentrations.

    Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins

Secondary outcomes

  1. IL-6

    Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins

  2. TNF-α

    Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins

  3. C-reactive protein

    Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins

  4. GLP-1

    Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins

  5. Insulin

    Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins

  6. Glucagon

    Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins

  7. Glucose

    Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins

  8. Leptin

    Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins

Sponsors and collaborators

Lead sponsor

Texas Christian University

Other

Registry information

Official study title

The Effect of Meal Composition on Blood Lipid Concentrations

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 20, 2015
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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