EnergyNCT00942695
Energy Value of Macronutrients From Pistachio Nuts and Mechanisms of Nutrient Action
A study testing 1.5PD and 3.0PD in people with Energy and Cardiovascular Disease, run by United States Department of Agriculture (USDA) at 1 site in United States.
Trial summary
The objective of this study is to measure the energy value of pistachios in the human diet and study molecular mechanisms that may help explain the beneficial health effects of pistachios. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy, Cardiovascular Disease, Cancer
- What is being tested?
- 1.5PD and 3.0PD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2009
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 25 to 65 years at beginning of study
- BMI between 20 and 38 kg/m2
- Fasting glucose < 126 mg/dl
- Blood pressure < 160/100 (controlled with certain medications)
- Fasting total blood cholesterol < 280 mg/dl
- Fasting triglycerides < 300 mg/dl
Who cannot join
- Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- History of bariatric or certain other surgeries related to weight control
- Smokers or other tobacco users (during 6 months prior to the start of the study)
- Antibiotic use during the intervention or for 3 weeks prior to any intervention period
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
Show all 11Show fewer
- Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
- Known (self-reported) allergy or adverse reaction to pistachios or other nuts
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA-ARS, Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
The objective of this study is to measure the energy value of pistachios in the human diet and study molecular mechanisms that may help explain the beneficial health effects of pistachios.
Read the detailed description
Previous studies have suggested that nut consumption imparts a variety of health benefits, including reduction of cardiovascular disease and improved satiety. However, studies of pistachios are extremely limited. The aim of this study is to determine the energy value of pistachios in the human diet and to probe mechanisms by which pistachios impart health benefits. The metabolizable energy value of pistachio nuts will be calculated based on the chemical composition and energy content of the consumed diet and excreta. This will provide a better estimate of the energy value of pistachios than simply calculating energy value based on Atwater factors. In addition to determining the energy value of pistachios, we will evaluate the effects of pistachio-rich diets on plasma phytonutrient levels and on gene expression changes to determine what protective mechanisms are activated by pistachio consumption.
- Conditions
- Energy, Cardiovascular Disease, Cancer
- Being tested
- 1.5PD, 3.0PD, control
- Keywords
- pistachio, nuts, energy value, cardiovascular disease, phytonutrient, gene expression, energy value of pistachio nuts
- Medical subject headings
- Cardiovascular Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5PDOther
average American diet plus 1.5 oz per day pistachios
3.0PDOther
average American diet plus 3.0 oz per day pistachios
controlOther
average American diet without pistachios
| Study group | Role | What they receive |
|---|---|---|
| base | Other | average American diet without pistachios Receives: Other: control |
| 1.5PD | Active comparator | average American diet plus 1.5 oz per day pistachios Receives: Other: 1.5PD |
| 3.0PD | Active comparator | average American diet plus 3.0 oz per day pistachios Receives: Other: 3.0PD |
What is being measured
The primary outcome is the main question the study is designed to answer.
to measure the energy value of pistachios in the human diet
Measured: 3 weeks
Secondary outcomes (1)
to study molecular mechanisms that may help explain the beneficial health effects of pistachios
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnergyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Department of Agriculture (USDA)
- Sponsor type
- US federal agency
- Collaborators
- Paramount Farms
- Investigators
- David J Baer, Ph. D., Principal investigator, United States Department of Agriculture (USDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942695
- Sponsor's protocol ID
- 2009-109
- Status last verified
- Feb 2011
- First submitted
- 17 Jul 2009
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Value of Macronutrients From Pistachio Nuts and Mechanisms of Nutrient Action
- ClinicalTrials.gov ID
- NCT00942695
- Acronym / sponsor ID
- 2009-109
- Conditions
- Energy, Cardiovascular Disease, Cancer
- Keywords
- pistachio, nuts, energy value, cardiovascular disease, phytonutrient, gene expression, energy value of pistachio nuts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- United States Department of Agriculture (USDA)US federal agency
- Collaborators
- Paramount Farms
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Jul 2009 (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 objective of this study is to measure the energy value of pistachios in the human diet and study molecular mechanisms that may help explain the beneficial health effects of pistachios.
Detailed description
Previous studies have suggested that nut consumption imparts a variety of health benefits, including reduction of cardiovascular disease and improved satiety. However, studies of pistachios are extremely limited. The aim of this study is to determine the energy value of pistachios in the human diet and to probe mechanisms by which pistachios impart health benefits. The metabolizable energy value of pistachio nuts will be calculated based on the chemical composition and energy content of the consumed diet and excreta. This will provide a better estimate of the energy value of pistachios than simply calculating energy value based on Atwater factors. In addition to determining the energy value of pistachios, we will evaluate the effects of pistachio-rich diets on plasma phytonutrient levels and on gene expression changes to determine what protective mechanisms are activated by pistachio consumption.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| base | Other | Other: controlaverage American diet without pistachios |
| 1.5PD | Active comparator | Other: 1.5PDaverage American diet plus 1.5 oz per day pistachios |
| 3.0PD | Active comparator | Other: 3.0PDaverage American diet plus 3.0 oz per day pistachios |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 25 to 65 years at beginning of study
- BMI between 20 and 38 kg/m2
- Fasting glucose < 126 mg/dl
- Blood pressure < 160/100 (controlled with certain medications)
- Fasting total blood cholesterol < 280 mg/dl
Key exclusion criteria (11 listed)
- Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- History of bariatric or certain other surgeries related to weight control
- Smokers or other tobacco users (during 6 months prior to the start of the study)
- Antibiotic use during the intervention or for 3 weeks prior to any intervention period
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 |
|---|---|---|
| 1.5PDaverage American diet plus 1.5 oz per day pistachios | Other | 1.5PD |
| 3.0PDaverage American diet plus 3.0 oz per day pistachios | Other | 3.0PD |
| controlaverage American diet without pistachios | Other | base |
Primary outcome
to measure the energy value of pistachios in the human diet
Time frame: 3 weeks
1 secondary outcome
to study molecular mechanisms that may help explain the beneficial health effects of pistachios
Time frame: 3 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 9 Feb 2011.
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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.
David J Baer, Ph. D. principal investigator
United States Department of Agriculture (USDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.5PD and 3.0PD in people with Energy and Cardiovascular Disease, run by United States Department of Agriculture (USDA) 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 6 inclusion and 11 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 9 Feb 2011. 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?
to measure the energy value of pistachios in the human diet (time frame: 3 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 9 Feb 2011.