Cardiovascular DiseasesNCT05087823
The Mixed Meal Challenge Study
A study testing Lipid Challenge, Glucose Challenge and Mixed Meal Challenge in people with Cardiovascular Diseases and Hyperlipidemias, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to assess sample collection conditions for various dietary challenges (fat, sugar, and mixed) and determine the optimal fasting and post-meal sample collection time points for future studies on a larger group of individuals. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Hyperlipidemias
- What is being tested?
- Lipid Challenge, Glucose Challenge and Mixed Meal Challenge
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 19 May 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Any adult (18 -50 years) may participate who agrees to complete the following requirements:
- Be functionally ambulatory
- Have a body mass index (BMI) between >20 kg/m2 to <40 kg/m2
- Be available for an 8-hour visit to the Emory University Hospital Clinical Research Center
- Be able to fast for 10 hours prior to visiting Emory University Hospital Clinical Research Unit for each meal challenge
Who cannot join
- Vulnerable populations which include children, pregnant women, individuals with mental disabilities, and prisoners will be excluded from the study.
- Individuals with history of GI symptoms or fat intolerance will be excluded from the study.
- Individuals with health condition that would put them in risk due to 10 hour fasting, including:
- Has taken any diabetic or lipid lowering prescription medications within the past 12 months
- History of chronic diseases
- Hospitalized within the last year
Show all 16Show fewer
- Currently pregnant
- Current active malignant neoplasm or history of malignancy (other than localized basal cell cancer of the skin) during the previous 5 years
- Current chronic autoimmune or pro-inflammatory disease
- History of tuberculosis, HIV, or other chronic infection
- Previous diagnosis of type 1 or type 2 diabetes with active treatment with insulin or other glucose lowering medication
- Advanced (>= stage 3) renal disease
- Recreational or prescription drug or alcohol abuse
- Any history of gastrointestinal diseases, including malabsorption
- Any history of intolerance to dietary fat
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurements of Lipoproteins, Apolipoproteins, and Lipids in Three Separate Oral Challenges - Fat, Sugar, and Mixed Test Meals
The purpose of this study is to assess sample collection conditions for various dietary challenges (fat, sugar, and mixed) and determine the optimal fasting and post-meal sample collection time points for future studies on a larger group of individuals. Study participants will attend three study visits where they take part in lipid, glucose, and mixed meal challenges. At each of the three visits, participants will provide venous blood samples and a urine sample before consuming the test meal and will provide 6 additional venous finger blood samples post-meal.
Read the detailed description
Cardiovascular disease (CVD) is the leading killer of Americans, accounting for more than 800,000 deaths each year. A vital step in reducing the number of heart disease-related deaths in the U.S. is to identify those at probable risk. The Clinical Chemistry Branch (CCB) in the Division of Laboratory Sciences (DLS) at the Centers for Disease Control and Prevention (CDC) has developed advanced analytical methods for assessing the risk for lipid metabolism related diseases, including CVD. This comprehensive analytical method measures levels of protein and lipid constituents of lipoprotein size and density classes (e.g. high-density lipoprotein (HDL), low-density lipoprotein (LDL) and very low-density lipoprotein (VLDL)) in blood. The analytical method uses asymmetric flow-field flow fractionation (AF4) to separate lipoprotein classes (HDL, LDL, VLDL) in serum or plasma into size fractions, and in each fraction quantifies over 50 CVD-linked biomarkers by isotope dilution tandem mass spectrometry. The CCB plans to apply the measurement of this wide array of biomarkers in future epidemiologic investigations of CVD. These studies have the potential to expand the number of diagnostically relevant CVD risk factors that currently are limited to cholesterol and triglyceride measurements.
However, there is limited information about how the CVD-linked biomarkers measured with the CCB's method are affected by blood collection conditions and the fasting/non-fasting state of individuals. Furthermore, lipid metabolism is very dynamic and the absolute levels of biomarkers are strongly affected by each individual's diet, lifestyle, gender, age, and physiology. Thus, assessing biomarkers related to lipid metabolism is most effective in a pre- and post-test comparison (i.e. fasting vs. after a test meal) with controlled lipid and carbohydrate content.
The study involves three different meal challenges on three separate days with approximately two weeks in between. The first meal challenge will involve the consumption of a standardized mixture of dietary fats (lipid challenge), the second meal challenge will be a sugar sweetened beverage (glucose challenge) and the third meal challenge will be a nutrition shake (mixed meal challenge). At each of the three visits, each individual will provide both venous and finger-prick blood samples and a urine sample before consuming the test meal (in a fasting state) and 6 additional venous and finger-prick blood samples post-meal at described intervals. Each study visit will last approximately 8 hours.
- Conditions
- Cardiovascular Diseases, Hyperlipidemias
- Being tested
- Lipid Challenge, Glucose Challenge, Mixed Meal Challenge
- Keywords
- Prevention, Hyperlipidemia, Cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid ChallengeDietary supplement
Also called Calogen
For the lipid challenge, participants consume 100 grams of a long chain triglyceride emulsion in the form of liquid drink, which is the commercially available brand called Calogen, from Nutricia, Inc.
Glucose ChallengeDietary supplement
For the glucose challenge, participants consume 75 grams of glucose in 200 milliliters of water, which is the World Health Organization (WHO) recommended drink for the Oral Glucose Tolerance Test.
Mixed Meal ChallengeDietary supplement
Also called Ensure Enlive
For the mixed-meal challenge, participants consume 237 milliliters of the Ensure Enlive nutrition drink , which contains 11 grams of fat, 22 grams of sugar and 20 grams of protein.
| Study group | Role | What they receive |
|---|---|---|
| Lipid, Glucose, and Mixed Meal Challenges | Experimental | Participants will take part in three different meal challenges on three separate days with approximately two weeks in between. The first meal challenge is the lipid challenge, the second meal challenge is the glucose challenge and third meal challenge is the mixed-meal challenge. Receives: Dietary Supplement: Lipid Challenge; Dietary Supplement: Glucose Challenge; Dietary Supplement: Mixed Meal Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in high-density lipoprotein (HDL) Size
HDL concentration size profiles for each time-point will be determined for each of the three meal challenges. HDL is considered to be anti- atherogenic because of its ability deplete excess cholesterol accumulating necrotic cores and repair arterial lesions.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in low-density lipoprotein (LDL) Size
LDL concentration size profiles for each time-point will be determined for each of the three meal challenges. LDL is considered to be atherogenic because it is likely to be trapped inside the intima of blood vessels and arteries and initiate inflammatory response, foam-cell formation, and smooth muscle cell proliferation, leading to development necrotic cores, lesions, plaques and their eventual rupture. Elevated LDL has been thought to contribute to atherosclerotic events, however, research has also observed coronary events occurring in individuals with LDL levels in the acceptable range.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Total Cholesterol
Total cholesterol profiles for each time-point will be determined for each of the three meal challenges. Elevated total cholesterol has been thought to contribute to atherosclerotic events, however, research has also observed coronary events occurring in individuals with total cholesterol levels in the acceptable range.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Free Cholesterol
Free cholesterol concentration for each time-point will be determined for each of the three meal challenges. Free cholesterol is unesterified cholesterol that is circulating in the blood stream.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Cholesterol Ester
Cholesterol ester concentration for each time-point will be determined for each of the three meal challenges. Lipoproteins contain cholesterol ester, and cholesterol ester is associated with atherosclerosis.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Triglycerides
Triglyceride concentration for each time-point will be determined for each of the three meal challenges. Triglycerides peak in serum 2 to 4 hours after a meal and return to a pre-meal state in 6 to 8 hours.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Phosphatidylinositol
Phosphatidylinositol concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Phosphatidylethanolamine
Phosphatidylethanolamine concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Phosphatidylcholine
Phosphatidylcholine concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Sphingomyelin
Sphingomyelin concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Lysophosphatidylcholine
Lysophosphatidylcholine concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Apolipoprotein AI
Apolipoprotein AI concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Apolipoprotein AII
Apolipoprotein AII concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Apolipoprotein AIV
Apolipoprotein AIV concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Apolipoprotein B
Apolipoprotein B concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Apolipoprotein CI
Apolipoprotein CI concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Apolipoprotein CII
Apolipoprotein CII concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Apolipoprotein CIII
Apolipoprotein CIII concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Apolipoprotein E
Apolipoprotein E concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Lecithin-Cholesterol Acyltransferase
Lecithin-cholesterol acyltransferase concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Cholesterol Ester Transfer Protein
Cholesterol ester transfer protein concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Lipoprotein (a)
Lipoprotein (a) concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Phospholipid Transfer Protein
Phospholipid transfer protein concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Serum Paraoxonase/arylesterase 1
Serum paraoxonase/arylesterase 1 concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Serum Amyloid A1
Serum amyloid A1 concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Change in Serum Amyloid A4
Serum amyloid A4 concentration for each time-point will be determined for each of the three meal challenges.
Measured: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start2 Nov 2021
- Primary completion19 May 2022
- Study completion19 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Thomas R. Ziegler, Emory University
- Investigators
- Thomas Ziegler, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087823
- Sponsor's protocol ID
- IRB00116934
- Status last verified
- Apr 2023
- First submitted
- 11 Oct 2021
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Lipoproteins, Apolipoproteins, and Lipids in Three Separate Oral Challenges - Fat, Sugar, and Mixed Test Meals
- ClinicalTrials.gov ID
- NCT05087823
- Acronym / sponsor ID
- IRB00116934
- Conditions
- Cardiovascular Diseases, Hyperlipidemias
- Keywords
- Prevention, Hyperlipidemia, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 21 Oct 2021 (actual)
- 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 assess sample collection conditions for various dietary challenges (fat, sugar, and mixed) and determine the optimal fasting and post-meal sample collection time points for future studies on a larger group of individuals. Study participants will attend three study visits where they take part in lipid, glucose, and mixed meal challenges. At each of the three visits, participants will provide venous blood samples and a urine sample before consuming the test meal and will provide 6 additional venous finger blood samples post-meal.
Detailed description
Cardiovascular disease (CVD) is the leading killer of Americans, accounting for more than 800,000 deaths each year. A vital step in reducing the number of heart disease-related deaths in the U.S. is to identify those at probable risk. The Clinical Chemistry Branch (CCB) in the Division of Laboratory Sciences (DLS) at the Centers for Disease Control and Prevention (CDC) has developed advanced analytical methods for assessing the risk for lipid metabolism related diseases, including CVD. This comprehensive analytical method measures levels of protein and lipid constituents of lipoprotein size and density classes (e.g. high-density lipoprotein (HDL), low-density lipoprotein (LDL) and very low-density lipoprotein (VLDL)) in blood. The analytical method uses asymmetric flow-field flow fractionation (AF4) to separate lipoprotein classes (HDL, LDL, VLDL) in serum or plasma into size fractions, and in each fraction quantifies over 50 CVD-linked biomarkers by isotope dilution tandem mass spectrometry. The CCB plans to apply the measurement of this wide array of biomarkers in future epidemiologic investigations of CVD. These studies have the potential to expand the number of diagnostically relevant CVD risk factors that currently are limited to cholesterol and triglyceride measurements.
However, there is limited information about how the CVD-linked biomarkers measured with the CCB's method are affected by blood collection conditions and the fasting/non-fasting state of individuals. Furthermore, lipid metabolism is very dynamic and the absolute levels of biomarkers are strongly affected by each individual's diet, lifestyle, gender, age, and physiology. Thus, assessing biomarkers related to lipid metabolism is most effective in a pre- and post-test comparison (i.e. fasting vs. after a test meal) with controlled lipid and carbohydrate content.
The study involves three different meal challenges on three separate days with approximately two weeks in between. The first meal challenge will involve the consumption of a standardized mixture of dietary fats (lipid challenge), the second meal challenge will be a sugar sweetened beverage (glucose challenge) and the third meal challenge will be a nutrition shake (mixed meal challenge). At each of the three visits, each individual will provide both venous and finger-prick blood samples and a urine sample before consuming the test meal (in a fasting state) and 6 additional venous and finger-prick blood samples post-meal at described intervals. Each study visit will last approximately 8 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipid, Glucose, and Mixed Meal Challenges | Experimental | Dietary Supplement: Lipid Challenge, Dietary Supplement: Glucose Challenge, Dietary Supplement: Mixed Meal ChallengeParticipants will take part in three different meal challenges on three separate days with approximately two weeks in between. The first meal challenge is the lipid challenge, the second meal challenge is the glucose challenge and third meal challenge is the mixed-meal challenge. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Any adult (18 -50 years) may participate who agrees to complete the following requirements:
- Be functionally ambulatory
- Have a body mass index (BMI) between >20 kg/m2 to <40 kg/m2
- Be available for an 8-hour visit to the Emory University Hospital Clinical Research Center
- Be able to fast for 10 hours prior to visiting Emory University Hospital Clinical Research Unit for each meal challenge
Key exclusion criteria (16 listed)
- Vulnerable populations which include children, pregnant women, individuals with mental disabilities, and prisoners will be excluded from the study.
- Individuals with history of GI symptoms or fat intolerance will be excluded from the study.
- Individuals with health condition that would put them in risk due to 10 hour fasting, including:
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 |
|---|---|---|
| Lipid ChallengeAlso: CalogenFor the lipid challenge, participants consume 100 grams of a long chain triglyceride emulsion in the form of liquid drink, which is the commercially available brand called Calogen, from Nutricia, Inc. | Dietary supplement | Lipid, Glucose, and Mixed Meal Challenges |
| Glucose ChallengeFor the glucose challenge, participants consume 75 grams of glucose in 200 milliliters of water, which is the World Health Organization (WHO) recommended drink for the Oral Glucose Tolerance Test. | Dietary supplement | Lipid, Glucose, and Mixed Meal Challenges |
| Mixed Meal ChallengeAlso: Ensure EnliveFor the mixed-meal challenge, participants consume 237 milliliters of the Ensure Enlive nutrition drink , which contains 11 grams of fat, 22 grams of sugar and 20 grams of protein. | Dietary supplement | Lipid, Glucose, and Mixed Meal Challenges |
Primary outcome
Change in high-density lipoprotein (HDL) Size
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
HDL concentration size profiles for each time-point will be determined for each of the three meal challenges. HDL is considered to be anti- atherogenic because of its ability deplete excess cholesterol accumulating necrotic cores and repair arterial lesions.
Change in low-density lipoprotein (LDL) Size
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
LDL concentration size profiles for each time-point will be determined for each of the three meal challenges. LDL is considered to be atherogenic because it is likely to be trapped inside the intima of blood vessels and arteries and initiate inflammatory response, foam-cell formation, and smooth muscle cell proliferation, leading to development necrotic cores, lesions, plaques and their eventual rupture. Elevated LDL has been thought to contribute to atherosclerotic events, however, research has also observed coronary events occurring in individuals with LDL levels in the acceptable range.
Change in Total Cholesterol
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Total cholesterol profiles for each time-point will be determined for each of the three meal challenges. Elevated total cholesterol has been thought to contribute to atherosclerotic events, however, research has also observed coronary events occurring in individuals with total cholesterol levels in the acceptable range.
Change in Free Cholesterol
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Free cholesterol concentration for each time-point will be determined for each of the three meal challenges. Free cholesterol is unesterified cholesterol that is circulating in the blood stream.
Change in Cholesterol Ester
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Cholesterol ester concentration for each time-point will be determined for each of the three meal challenges. Lipoproteins contain cholesterol ester, and cholesterol ester is associated with atherosclerosis.
Change in Triglycerides
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Triglyceride concentration for each time-point will be determined for each of the three meal challenges. Triglycerides peak in serum 2 to 4 hours after a meal and return to a pre-meal state in 6 to 8 hours.
Change in Phosphatidylinositol
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Phosphatidylinositol concentration for each time-point will be determined for each of the three meal challenges.
Change in Phosphatidylethanolamine
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Phosphatidylethanolamine concentration for each time-point will be determined for each of the three meal challenges.
Change in Phosphatidylcholine
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Phosphatidylcholine concentration for each time-point will be determined for each of the three meal challenges.
Change in Sphingomyelin
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Sphingomyelin concentration for each time-point will be determined for each of the three meal challenges.
Change in Lysophosphatidylcholine
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Lysophosphatidylcholine concentration for each time-point will be determined for each of the three meal challenges.
Change in Apolipoprotein AI
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Apolipoprotein AI concentration for each time-point will be determined for each of the three meal challenges.
Change in Apolipoprotein AII
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Apolipoprotein AII concentration for each time-point will be determined for each of the three meal challenges.
Change in Apolipoprotein AIV
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Apolipoprotein AIV concentration for each time-point will be determined for each of the three meal challenges.
Change in Apolipoprotein B
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Apolipoprotein B concentration for each time-point will be determined for each of the three meal challenges.
Change in Apolipoprotein CI
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Apolipoprotein CI concentration for each time-point will be determined for each of the three meal challenges.
Change in Apolipoprotein CII
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Apolipoprotein CII concentration for each time-point will be determined for each of the three meal challenges.
Change in Apolipoprotein CIII
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Apolipoprotein CIII concentration for each time-point will be determined for each of the three meal challenges.
Change in Apolipoprotein E
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Apolipoprotein E concentration for each time-point will be determined for each of the three meal challenges.
Change in Lecithin-Cholesterol Acyltransferase
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Lecithin-cholesterol acyltransferase concentration for each time-point will be determined for each of the three meal challenges.
Change in Cholesterol Ester Transfer Protein
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Cholesterol ester transfer protein concentration for each time-point will be determined for each of the three meal challenges.
Change in Lipoprotein (a)
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Lipoprotein (a) concentration for each time-point will be determined for each of the three meal challenges.
Change in Phospholipid Transfer Protein
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Phospholipid transfer protein concentration for each time-point will be determined for each of the three meal challenges.
Change in Serum Paraoxonase/arylesterase 1
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Serum paraoxonase/arylesterase 1 concentration for each time-point will be determined for each of the three meal challenges.
Change in Serum Amyloid A1
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Serum amyloid A1 concentration for each time-point will be determined for each of the three meal challenges.
Change in Serum Amyloid A4
Time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)
Serum amyloid A4 concentration for each time-point will be determined for each of the three meal challenges.
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 1 May 2023.
- Individual participant dataSharing planned: No
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Heart Failure
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Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 1/2
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
Relapsed/Refractory Multiple Myeloma
RecruitingPhase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
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.
Thomas Ziegler, MD principal investigator
Emory 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 Lipid Challenge, Glucose Challenge and Mixed Meal Challenge in people with Cardiovascular Diseases and Hyperlipidemias, run by Emory 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 5 inclusion and 16 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 1 May 2023. 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?
Change in high-density lipoprotein (HDL) Size (time frame: Baseline, Minute 15, Minute 30, Hour 1, Hour 2, Hour 4 and Hour 6 during study visits 1, 2, and 3 (up to 6 weeks)). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2023.