Dietary Intake of Branched Chain Amino AcidsNCT02110602
Dietary Intake and Circulating Levels of Branched Chain Amino Acids
A study testing Diet high in amino acid levels and Diet low in amino acid levels in people with Dietary Intake of Branched Chain Amino Acids, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators are conducting this research study to find out if eating low or high levels of specific amino acids changes the levels of these same amino acids in the blood. Amino acids are the building blocks of protein that are normally found in food. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Intake of Branched Chain Amino Acids
- What is being tested?
- Diet high in amino acid levels and Diet low in amino acid levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Aug 2014
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males
- Ages 20-40
- Healthy
Who cannot join
- Age less than 20 or greater than 40
- Female sex
- Use of medications and herbal or vitamin supplements during the study or less than one month prior to enrollment in the study
- Body mass index (BMI) less than 20 or greater than 25
- Changes of more than 5 pounds in weight (increase or decrease) during the month prior to enrollment in the study
- Participation in more than 300 minutes of exercise per week during the month prior to enrollment in the study or plans for changes in exercise level during the study
Show all 13Show fewer
- Known diabetes or pre-diabetes (based on prior diagnoses; use of medications to lower glucose; or fasting blood glucose > 100mg/dL at screening)
- Untreated hypertension (defined as systolic blood pressure > 140mmHg and diastolic blood pressure > 90mmHg)
- Use of nicotine-containing products, including those inhaled, chewed, or patches during the study.
- Use of drugs of abuse.
- Conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric surgery
- Restrictions that prevent adherence to standardized meals or unwillingness to adhere to a pre-specified meal plan, including abstinence from alcohol and limitation to 1 caffeinated beverage per day
- Known anemia (men, hematocrit < 38%) based on prior testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Short-term Dietary Intake and Branched Chain Amino Acids
The investigators are conducting this research study to find out if eating low or high levels of specific amino acids changes the levels of these same amino acids in the blood. Amino acids are the building blocks of protein that are normally found in food. The amino acids the investigators are studying are called branched chain amino acids. The investigators will look at the levels (amount) of branched chain amino acids in blood before and after consumption of specially prepared meals. The investigators hypothesize that circulating branch chain amino acid (BCAA) levels will be lower following a low BCAA-content diet compared with a high BCAA-content diet.
- Being tested
- Diet high in amino acid levels, Diet low in amino acid levels
- Keywords
- Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet high in amino acid levelsOther
Also called Amino Acid supplements to be used in prepared meals:, Vitaflo MSUD express, l-isoleucine, l-leucine
Meals will be prepared in the Clinical Research Center Metabolism \& Nutrition Metabolic Kitchen, and participants will eat only this food during the controlled-diet periods of the study. The diets will contain equivalent calories (matched to the requirements of each participant) and either a low or high percentage of all BCAAs relative to protein content.
Diet low in amino acid levelsOther
Meals will be prepared in the Clinical Research Center Metabolism \& Nutrition Metabolic Kitchen, and participants will eat only this food during the controlled-diet periods of the study. The diets will contain equivalent calories (matched to the requirements of each participant) and either a low or high percentage of all BCAAs relative to protein content.
| Study group | Role | What they receive |
|---|---|---|
| Initial Diet - high in amino acid levels | Experimental | Visit 1 (Day 1): Screening Visit
Visit 2 (14-21 days after Visit 1): Begin high amino acid diet
Visit 3 (4 days after Visit 2): Completion of high amino acid diet
Visit 4 (3 days after Visit 3): Begin low amino acid diet
Visit 5 (4 days after Visit 4): Completion of low amino acid diet, completion of study Receives: Other: Diet high in amino acid levels; Other: Diet low in amino acid levels |
| Initial Diet - low in amino acid levels | Experimental | Visit 1 (Day 1): Screening Visit
Visit 2 (14-21 days after Visit 1): Begin low amino acid diet
Visit 3 (4 days after Visit 2): Completion of low amino acid diet
Visit 4 (3 days after Visit 3): Begin high amino acid diet
Visit 5 (4 days after Visit 4): Completion of high amino acid diet, completion of study Receives: Other: Diet high in amino acid levels; Other: Diet low in amino acid levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Branch Chain Amino Acid levels following diet interventions
A comparison of branched chain amino acid levels (as measured by mass spectrometry) following 4 days of a low and following 4 days of a high BCAA-content diet
Measured: 4 days
Secondary outcomes (1)
Change in fasting BCAA levels from native dietary intake to completion of diet intervention
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary Intake of Branched Chain Amino AcidsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geoffrey Walford, MD, Massachusetts General Hospital
- Investigators
- Geoffrey Walford, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110602
- Sponsor's protocol ID
- 2013P002607
- Status last verified
- Oct 2016
- First submitted
- 12 Mar 2014
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cavallaro NL, Garry J, Shi X, Gerszten RE, Anderson EJ, Walford GA. A pilot, short-term dietary manipulation of branched chain amino acids has modest influence on fasting levels of branched chain amino acids. Food Nutr Res. 2016 Jan 14;60:28592. doi: 10.3402/fnr.v60.28592. eCollection 2016.
PubMed 26781817
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Dietary Intake and Branched Chain Amino Acids
- ClinicalTrials.gov ID
- NCT02110602
- Acronym / sponsor ID
- 2013P002607
- Keywords
- Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Apr 2014 (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 investigators are conducting this research study to find out if eating low or high levels of specific amino acids changes the levels of these same amino acids in the blood. Amino acids are the building blocks of protein that are normally found in food. The amino acids the investigators are studying are called branched chain amino acids. The investigators will look at the levels (amount) of branched chain amino acids in blood before and after consumption of specially prepared meals. The investigators hypothesize that circulating branch chain amino acid (BCAA) levels will be lower following a low BCAA-content diet compared with a high BCAA-content diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial Diet - high in amino acid levels | Experimental | Other: Diet high in amino acid levels, Other: Diet low in amino acid levelsVisit 1 (Day 1): Screening Visit Visit 2 (14-21 days after Visit 1): Begin high amino acid diet Visit 3 (4 days after Visit 2): Completion of high amino acid diet Visit 4 (3 days after Visit 3): Begin low amino acid diet Visit 5 (4 days after Visit 4): Completion of low amino acid diet, completion of study |
| Initial Diet - low in amino acid levels | Experimental | Other: Diet high in amino acid levels, Other: Diet low in amino acid levelsVisit 1 (Day 1): Screening Visit Visit 2 (14-21 days after Visit 1): Begin low amino acid diet Visit 3 (4 days after Visit 2): Completion of low amino acid diet Visit 4 (3 days after Visit 3): Begin high amino acid diet Visit 5 (4 days after Visit 4): Completion of high amino acid diet, completion of study |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult males
- Ages 20-40
- Healthy
Key exclusion criteria (13 listed)
- Age less than 20 or greater than 40
- Female sex
- Use of medications and herbal or vitamin supplements during the study or less than one month prior to enrollment in the study
- Body mass index (BMI) less than 20 or greater than 25
- Changes of more than 5 pounds in weight (increase or decrease) during the month prior to enrollment in the study
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 |
|---|---|---|
| Diet high in amino acid levelsAlso: Amino Acid supplements to be used in prepared meals:, Vitaflo MSUD express, l-isoleucine, l-leucineMeals will be prepared in the Clinical Research Center Metabolism \& Nutrition Metabolic Kitchen, and participants will eat only this food during the controlled-diet periods of the study. The diets will contain equivalent calories (matched to the requirements of each participant) and either a low or high percentage of all BCAAs relative to protein content. | Other | Initial Diet - high in amino acid levels, Initial Diet - low in amino acid levels |
| Diet low in amino acid levelsMeals will be prepared in the Clinical Research Center Metabolism \& Nutrition Metabolic Kitchen, and participants will eat only this food during the controlled-diet periods of the study. The diets will contain equivalent calories (matched to the requirements of each participant) and either a low or high percentage of all BCAAs relative to protein content. | Other | Initial Diet - high in amino acid levels, Initial Diet - low in amino acid levels |
Primary outcome
Comparison of Branch Chain Amino Acid levels following diet interventions
Time frame: 4 days
A comparison of branched chain amino acid levels (as measured by mass spectrometry) following 4 days of a low and following 4 days of a high BCAA-content diet
1 secondary outcome
Change in fasting BCAA levels from native dietary intake to completion of diet intervention
Time frame: 4 days
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 7 Oct 2016.
- Derived from this study: PubMed 26781817Cavallaro NL, Garry J, Shi X, Gerszten RE, Anderson EJ, Walford GA. A pilot, short-term dietary manipulation of branched chain amino acids has modest influence on fasting levels of branched chain amino acids. Food Nutr Res. 2016 Jan 14;60:28592. doi: 10.3402/fnr.v60.28592. eCollection 2016.
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.
Geoffrey Walford, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet high in amino acid levels and Diet low in amino acid levels in people with Dietary Intake of Branched Chain Amino Acids, run by Massachusetts General Hospital 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 3 inclusion and 13 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 7 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. 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?
Comparison of Branch Chain Amino Acid levels following diet interventions (time frame: 4 days). 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 NCT02110602, which also lists 1 linked publication.
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 7 Oct 2016.