The Effect of Meal Composition on Blood Lipids

Dyslipidemia Clinical Trial

Official title:

The Effect of Meal Composition on Blood Lipid Concentrations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529709
• Other study ID #: TexasCU
• Status: Completed
• Phase: N/A
• First received: August 14, 2015
• Last updated: April 19, 2016
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Texas Christian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Other:
• High-Protein Condition
The participants will be fed a high-protein meal
• High-Monounsaturated Fat Condition
The participants will be fed a high-monounsaturated fat meal

Locations

Country	Name	City	State
United States	Texas Christian University	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Christian University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood lipid concentrations.		At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins	Yes
Secondary	IL-6		At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins	Yes
Secondary	TNF-a		At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins	Yes
Secondary	C-reactive protein		At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins	Yes
Secondary	GLP-1		At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins	Yes
Secondary	Insulin		At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins	Yes
Secondary	Glucagon		At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins	Yes
Secondary	Glucose		At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins	Yes
Secondary	Leptin		At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins	Yes