Clinical trial NCT02529709: The Effect of Meal Composition on Blood Lipids
Official title: The Effect of Meal Composition on Blood Lipid Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemia
Lead sponsor: Texas Christian University
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood lipid concentrations.
timeFrame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Secondary outcomes:
measure: IL-6
timeFrame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
measure: TNF-α
timeFrame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
measure: C-reactive protein
timeFrame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
measure: GLP-1
timeFrame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
measure: Insulin
timeFrame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
measure: Glucagon
timeFrame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
measure: Glucose
timeFrame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
measure: Leptin
timeFrame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Texas Christian University
state: Texas
Study officials:
affiliation: Tzu Chi University
name: Meena Shah, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1093/ajcn/81.4.762.
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. doi: 10.1016/0021-9150(87)90020-7.
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. doi: 10.1001/jama.298.3.309.