HypertriglyceridemiaNCT01150188
Effects of Amino Acids on Regional Lipid Metabolism
A study testing Amino acids in people with Hypertriglyceridemia, run by University of Arkansas at 1 site in United States.
Trial summary
Elevated fat level in blood is a risk factor for coronary heart disease, a major cause of death in America. The overall goal of this project is to test a novel treatment using nutrient (amino acid) supplementation against this condition in men and women, and to understand how this treatment works. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Amino acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-75 years.
- Men and Women (Women postmenopausal).
- Ability to sign informed consent, including ≥26 Mini-Mental State Exam.
- Plasma triglyceride concentration between 130-500 mg/dl.
Who cannot join
- Diabetes (plasma glucose: fasting ≥126 mg/dl or ≥200 mg/dl at 2 hr after 75 g glucose load).
- On diabetes medication or lipid altering agents, including over the counter fish oil/omega 3 fatty acids.
- Kidney/renal or liver disease.
- Bleeding disorders or anemia.
- Endocrine disease.
- Positive hepatitis or HIV screens.
Show all 10Show fewer
- Alcohol abuse or drug abuse
- Score of <26 on the Mini-Mental State Exam.
- Allergy to iodine or fish products.
- Subjects with cerebral aneurysm clips, internal transistorized devices (e.g., neural stimulators), or cardiac pacemakers.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Science, Reynolds Aging Institute
Little Rock, Arkansas, 72205
About this study
Elevated fat level in blood is a risk factor for coronary heart disease, a major cause of death in America. The overall goal of this project is to test a novel treatment using nutrient (amino acid) supplementation against this condition in men and women, and to understand how this treatment works.
Read the detailed description
Coronary heart disease (CHD) remains the single largest killer of American men and women (45). Hyper¬triglyceridemia (elevated triglyceride [TG] concentration in the blood) has been shown to be a significant independent risk factor for CHD (7;8;25), accordingly, treatment for hypertriglyceridemia has been included in the Adult Treatment Panel III (ATP III) of the National Cholesterol Education Program (36). In a meta-analysis of 21 population-based prospective studies including a total of 65,863 men and 11,089 women, each increase of 89 mg/dl (1 mmol/l) in TG concentration was associated with a 32% increase in CHD risk in men and 76% increase in women (3). Thus, hypertriglyceridemia is an even stronger risk factor for CHD in women than in men.
The prevalence of hypertriglyceridemia is high. It is a common finding with aging, and is also associated with overweight, obesity, diabetes, and renal disease (39). With the aging of the US population and ongoing epidemics of obesity and type 2-diabetes, the number of individuals with conditions associated with elevated TG levels is likely to grow.
4.1.2 Effect of Amino Acids on Plasma Triglyceride Concentration In an effort to clarify the potential independent effect of protein on plasma and tissue lipids, we supplemented a normal weight-maintaining diet with a relatively small amount of amino acids (~90 kcal/day) between meals. We measured tissue lipids in addition to plasma lipids since the increase in insulin resistance with aging has been linked to increased fat accumulation in muscle and liver tissue (20;63). Also, it has repeatedly been shown that amino acid intake stimulates muscle protein synthesis and improves muscle protein net balance (86). Our hypothesis was that supplementation of the normal diet with a mixture of amino acids will reduce circulating and tissue TG concentrations and improve insulin sensitivity in elderly subjects with impaired glucose tolerance. Twelve impaired glucose tolerant elderly ingested 11 g of essential amino acids (EAA) + arginine twice a day for 16 weeks, after a 7 week control run in. Diet and activity were not otherwise modified. We found individuals consuming the EAA supplement had improved physical function. Further, these individuals had lower plasma and liver TG concentrations than before supplementation, and total cholesterol and VLDL-cholesterol concentrations were also lower after supplementations (12). In the present study, we will investigate this by supplementing the diet of older subjects shown to have hypertriglyceridemia.
- Conditions
- Hypertriglyceridemia
- Being tested
- Amino acids, Placebo
- Keywords
- aging, lipid metabolism, very low density lipoproteins, amino acids, dietary supplements
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino acidsDietary supplement
11 g amino acids two times per day for eight weeks
PlaceboDietary supplement
Placebo of inert compounds, 11 g two times per day for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Amino acids | Active comparator | Amino acid supplementation between meals for eight weeks Receives: Dietary Supplement: Amino acids |
| Placebo | Placebo comparator | Supplementation of placebo (inert components) between meals for eight weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Very low density lipoprotein (VLDL) turnover
Turnover rates of VLDL-triglycerides and VLDL-ApoB-100, including synthesis and breakdown rates, measured before and after eight weeks of amino acid supplementation
Measured: Eight weeks
Secondary outcomes (3)
Fat oxidation
Fat oxidation measured before and after eight weeks of amino acid supplementation
Measured: 8 weeks
Lipolysis
Lipolysis measured before and after eight weeks of amino acid supplementation
Measured: 8 weeks
Triglyceride uptake in muscle and adipose tissue
Triglyceride uptake in muscle and adipose tissue measured before and after eight weeks of amino acid supplementation
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Elisabet Borsheim, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150188
- Sponsor's protocol ID
- 139210
- Other IDs
- 1R01AG033761-01A1
- Status last verified
- Oct 2016
- First submitted
- 22 Jun 2010
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Amino Acids on Regional Lipid Metabolism
- ClinicalTrials.gov ID
- NCT01150188
- Acronym / sponsor ID
- 139210
- Conditions
- Hypertriglyceridemia
- Keywords
- aging, lipid metabolism, very low density lipoproteins, amino acids, dietary supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jun 2010
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Jun 2010 (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.
Elevated fat level in blood is a risk factor for coronary heart disease, a major cause of death in America. The overall goal of this project is to test a novel treatment using nutrient (amino acid) supplementation against this condition in men and women, and to understand how this treatment works.
Detailed description
Coronary heart disease (CHD) remains the single largest killer of American men and women (45). Hyper¬triglyceridemia (elevated triglyceride [TG] concentration in the blood) has been shown to be a significant independent risk factor for CHD (7;8;25), accordingly, treatment for hypertriglyceridemia has been included in the Adult Treatment Panel III (ATP III) of the National Cholesterol Education Program (36). In a meta-analysis of 21 population-based prospective studies including a total of 65,863 men and 11,089 women, each increase of 89 mg/dl (1 mmol/l) in TG concentration was associated with a 32% increase in CHD risk in men and 76% increase in women (3). Thus, hypertriglyceridemia is an even stronger risk factor for CHD in women than in men.
The prevalence of hypertriglyceridemia is high. It is a common finding with aging, and is also associated with overweight, obesity, diabetes, and renal disease (39). With the aging of the US population and ongoing epidemics of obesity and type 2-diabetes, the number of individuals with conditions associated with elevated TG levels is likely to grow.
4.1.2 Effect of Amino Acids on Plasma Triglyceride Concentration In an effort to clarify the potential independent effect of protein on plasma and tissue lipids, we supplemented a normal weight-maintaining diet with a relatively small amount of amino acids (~90 kcal/day) between meals. We measured tissue lipids in addition to plasma lipids since the increase in insulin resistance with aging has been linked to increased fat accumulation in muscle and liver tissue (20;63). Also, it has repeatedly been shown that amino acid intake stimulates muscle protein synthesis and improves muscle protein net balance (86). Our hypothesis was that supplementation of the normal diet with a mixture of amino acids will reduce circulating and tissue TG concentrations and improve insulin sensitivity in elderly subjects with impaired glucose tolerance. Twelve impaired glucose tolerant elderly ingested 11 g of essential amino acids (EAA) + arginine twice a day for 16 weeks, after a 7 week control run in. Diet and activity were not otherwise modified. We found individuals consuming the EAA supplement had improved physical function. Further, these individuals had lower plasma and liver TG concentrations than before supplementation, and total cholesterol and VLDL-cholesterol concentrations were also lower after supplementations (12). In the present study, we will investigate this by supplementing the diet of older subjects shown to have hypertriglyceridemia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amino acids | Active comparator | Dietary Supplement: Amino acidsAmino acid supplementation between meals for eight weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSupplementation of placebo (inert components) between meals for eight weeks |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 50-75 years.
- Men and Women (Women postmenopausal).
- Ability to sign informed consent, including ≥26 Mini-Mental State Exam.
- Plasma triglyceride concentration between 130-500 mg/dl.
Key exclusion criteria (10 listed)
- Diabetes (plasma glucose: fasting ≥126 mg/dl or ≥200 mg/dl at 2 hr after 75 g glucose load).
- On diabetes medication or lipid altering agents, including over the counter fish oil/omega 3 fatty acids.
- Kidney/renal or liver disease.
- Bleeding disorders or anemia.
- Endocrine disease.
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 |
|---|---|---|
| Amino acids11 g amino acids two times per day for eight weeks | Dietary supplement | Amino acids |
| PlaceboPlacebo of inert compounds, 11 g two times per day for eight weeks | Dietary supplement | Placebo |
Primary outcome
Very low density lipoprotein (VLDL) turnover
Time frame: Eight weeks
Turnover rates of VLDL-triglycerides and VLDL-ApoB-100, including synthesis and breakdown rates, measured before and after eight weeks of amino acid supplementation
3 secondary outcomes
Fat oxidation
Time frame: 8 weeks
Lipolysis
Time frame: 8 weeks
Triglyceride uptake in muscle and adipose tissue
Time frame: Eight weeks
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 27 Oct 2016.
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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.
Elisabet Borsheim, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino acids in people with Hypertriglyceridemia, run by University of Arkansas 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 4 inclusion and 10 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 27 Oct 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. Some participants in this study may receive a placebo. 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?
Very low density lipoprotein (VLDL) turnover (time frame: Eight weeks). 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 27 Oct 2016.