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CompletedNCT02529709Updated Apr 21, 2016

The Effect of Meal Composition on Blood Lipids

An interventional study of High-Protein Condition and High-Monounsaturated Fat Condition in Dyslipidemia, sponsored by Texas Christian University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-21.

Sponsored by Texas Christian University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Dyslipidemia

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03

In context

Dyslipidemias

1,102 studies on the registry are indexed under Dyslipidemias; 161 are open to participants now.

This study's enrollment of 24 is below the median of 100 across 861 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Texas Christian University is the lead sponsor of 34 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women ages 18-65 years.

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    High-protein meal condition

    Other: High-Protein Condition

  • Active comparator
    High-monounsaturated fat meal condition

    Other: High-Monounsaturated Fat Condition

Interventions

  • OtherHigh-Protein Condition

    The participants will be fed a high-protein meal

  • OtherHigh-Monounsaturated Fat Condition

    The participants will be fed a high-monounsaturated fat meal

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What researchers measure

Primary outcomes

  1. 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 outcomes

  1. IL-6

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

  2. TNF-α

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

  3. C-reactive protein

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

  4. GLP-1

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

  5. Insulin

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

  6. Glucagon

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

  7. Glucose

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

  8. Leptin

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

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Study locations

1 site
  • Texas Christian University
    Fort Worth, Texas 76129, United States
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References and documents

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. PubMed 16287956 ↗
  • 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. PubMed 15817850 ↗
  • 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. PubMed 3496893 ↗
  • 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. PubMed 17635891 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2015, a primary completion of Apr 2016 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2015
First posted
Aug 20, 2015
Start
Oct 2015
Primary completionActual
Apr 2016
CompletionActual
Apr 2016
Last update
Apr 21, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02529709
Lead sponsor
Texas Christian University
Responsible party
Meena Shah (Professor, Texas Christian University) — Principal investigator
First posted
Aug 20, 2015
Start date
Oct 2015
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Apr 21, 2016

Study contacts

Meena Shah, Ph.D.
principal investigator · Tzu Chi University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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