NCT02529709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

August 14, 2015

Last Update Submit

April 19, 2016

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Blood lipid concentrations.

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

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

High-protein meal condition

EXPERIMENTAL
Other: High-Protein Condition

High-monounsaturated fat meal condition

ACTIVE COMPARATOR
Other: High-Monounsaturated Fat Condition

Interventions

High-Protein ConditionOTHER

The participants will be fed a high-protein meal

High-protein meal condition
High-Monounsaturated Fat ConditionOTHER

The participants will be fed a high-monounsaturated fat meal

High-monounsaturated fat meal condition

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women ages 18-65 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76129, United States

Location

Related 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. doi: 10.1001/jama.294.19.2455.

    PMID: 16287956BACKGROUND

  • 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.

    PMID: 15817850BACKGROUND

  • 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.

    PMID: 3496893BACKGROUND

  • 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.

    PMID: 17635891BACKGROUND

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Meena Shah, Ph.D.

    Tzu Chi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 20, 2015

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 21, 2016

Record last verified: 2016-04

Locations

US(1)