The Effect of Meal Composition on Blood Lipids

The Effect of Meal Composition on Blood Lipid Concentrations

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Other: High-Protein Condition; Other: High-Monounsaturated Fat Condition

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76129
      • Texas Christian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-protein meal condition	Other: High-Protein Condition; The participants will be fed a high-protein meal
Active Comparator: High-monounsaturated fat meal condition	Other: High-Monounsaturated Fat Condition; The participants will be fed a high-monounsaturated fat meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood lipid concentrations.	At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins

Secondary Outcome Measures

Outcome Measure	Time Frame
IL-6	At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
TNF-α	At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
C-reactive protein	At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
GLP-1	At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Insulin	At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Glucagon	At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Glucose	At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Leptin	At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins

Collaborators and Investigators

• Sponsor: Texas Christian University
• Investigators: Principal Investigator: Meena Shah, Ph.D., Tzu Chi University

Publications and helpful links

General Publications

• Appel LJ, Sacks FM, Carey VJ, Obarzanek E, Swain JF, Miller ER 3rd, Conlin PR, Erlinger TP, Rosner BA, Laranjo NM, Charleston J, McCarron P, Bishop LM; OmniHeart Collaborative Research Group. Effects of protein, monounsaturated fat, and carbohydrate intake on blood pressure and serum lipids: results of the OmniHeart randomized trial. JAMA. 2005 Nov 16;294(19):2455-64. doi: 10.1001/jama.294.19.2455.
• Luscombe-Marsh ND, Noakes M, Wittert GA, Keogh JB, Foster P, Clifton PM. Carbohydrate-restricted diets high in either monounsaturated fat or protein are equally effective at promoting fat loss and improving blood lipids. Am J Clin Nutr. 2005 Apr;81(4):762-72. doi: 10.1093/ajcn/81.4.762.
• Simons LA, Dwyer T, Simons J, Bernstein L, Mock P, Poonia NS, Balasubramaniam S, Baron D, Branson J, Morgan J, et al. Chylomicrons and chylomicron remnants in coronary artery disease: a case-control study. Atherosclerosis. 1987 May;65(1-2):181-9. doi: 10.1016/0021-9150(87)90020-7.
• Bansal S, Buring JE, Rifai N, Mora S, Sacks FM, Ridker PM. Fasting compared with nonfasting triglycerides and risk of cardiovascular events in women. JAMA. 2007 Jul 18;298(3):309-16. doi: 10.1001/jama.298.3.309.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: August 14, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (Estimate): August 20, 2015

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: TexasCU