DyslipidemiaNCT02529709
The Effect of Meal Composition on Blood Lipids
A study testing High-Protein Condition and High-Monounsaturated Fat Condition in people with Dyslipidemia, run by Texas Christian University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- High-Protein Condition and High-Monounsaturated Fat Condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women ages 18-65 years.
Who cannot join
- 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,
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Meal Composition on Blood Lipid Concentrations
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.
- Conditions
- Dyslipidemia
- Being tested
- High-Protein Condition, High-Monounsaturated Fat Condition
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Protein ConditionOther
The participants will be fed a high-protein meal
High-Monounsaturated Fat ConditionOther
The participants will be fed a high-monounsaturated fat meal
| Study group | Role | What they receive |
|---|---|---|
| High-protein meal condition | Experimental | Not described Receives: Other: High-Protein Condition |
| High-monounsaturated fat meal condition | Active comparator | Not described Receives: Other: High-Monounsaturated Fat Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lipid concentrations.
Measured: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Secondary outcomes (8)
IL-6
Measured: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
TNF-α
Measured: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
C-reactive protein
Measured: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
GLP-1
Measured: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Insulin
Measured: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Glucagon
Measured: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Glucose
Measured: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Leptin
Measured: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meena Shah, Texas Christian University
- Investigators
- Meena Shah, Ph.D., Principal investigator, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529709
- Sponsor's protocol ID
- TexasCU
- Status last verified
- Apr 2016
- First submitted
- 14 Aug 2015
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
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 16287956Luscombe-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 15817850Simons 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 3496893Bansal 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Meal Composition on Blood Lipid Concentrations
- ClinicalTrials.gov ID
- NCT02529709
- Acronym / sponsor ID
- TexasCU
- Conditions
- Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-protein meal condition | Experimental | Other: High-Protein Condition |
| High-monounsaturated fat meal condition | Active comparator | Other: High-Monounsaturated Fat Condition |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women ages 18-65 years.
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Protein ConditionThe participants will be fed a high-protein meal | Other | High-protein meal condition |
| High-Monounsaturated Fat ConditionThe participants will be fed a high-monounsaturated fat meal | Other | High-monounsaturated fat meal condition |
Primary outcome
Blood lipid concentrations.
Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
8 secondary outcomes
IL-6
Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
TNF-α
Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
C-reactive protein
Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
GLP-1
Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Insulin
Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Glucagon
Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Glucose
Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Leptin
Time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Background: PubMed 16287956Appel 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.
- Background: PubMed 15817850Luscombe-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.
- Background: PubMed 3496893Simons 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.
- Background: PubMed 17635891Bansal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meena Shah, Ph.D. principal investigator
Tzu Chi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Protein Condition and High-Monounsaturated Fat Condition in people with Dyslipidemia, run by Texas Christian University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood lipid concentrations. (time frame: At 0 minute before the meal begins and at 30, 60, 120, and 180 minutes after the meal begins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02529709, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.