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The Effect of Meal Composition on Blood Lipids

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-Protein Condition
High-Monounsaturated Fat Condition
Sponsored by
Texas Christian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Texas Christian University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-protein meal condition

High-monounsaturated fat meal condition

Arm Description

Outcomes

Primary Outcome Measures

Blood lipid concentrations.

Secondary Outcome Measures

IL-6
TNF-α
C-reactive protein
GLP-1
Insulin
Glucagon
Glucose
Leptin

Full Information

First Posted
August 14, 2015
Last Updated
April 19, 2016
Sponsor
Texas Christian University
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1. Study Identification

Unique Protocol Identification Number
NCT02529709
Brief Title
The Effect of Meal Composition on Blood Lipids
Official Title
The Effect of Meal Composition on Blood Lipid Concentrations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Christian University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-protein meal condition
Arm Type
Experimental
Arm Title
High-monounsaturated fat meal condition
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
High-Protein Condition
Intervention Description
The participants will be fed a high-protein meal
Intervention Type
Other
Intervention Name(s)
High-Monounsaturated Fat Condition
Intervention Description
The participants will be fed a high-monounsaturated fat meal
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
IL-6
Time Frame
At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Title
TNF-α
Time Frame
At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Title
C-reactive protein
Time Frame
At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Title
GLP-1
Time Frame
At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Title
Insulin
Time Frame
At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Title
Glucagon
Time Frame
At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Title
Glucose
Time Frame
At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Title
Leptin
Time Frame
At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meena Shah, Ph.D.
Organizational Affiliation
Tzu Chi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Christian University
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76129
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16287956
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.
Results Reference
background
PubMed Identifier
15817850
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.
Results Reference
background
PubMed Identifier
3496893
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.
Results Reference
background
PubMed Identifier
17635891
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.
Results Reference
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The Effect of Meal Composition on Blood Lipids

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