Cardiovascular Disease RiskNCT01950806
The Effect of Pecans on Biomarkers of Risk for Cardiovascular Disease and Diabetes
A study testing Pecan-containing diet and Nut-free diet in people with Cardiovascular Disease Risk and Type 2 Diabetes Risk, run by Tufts University at 1 site in United States.
Trial summary
The objective of this randomized, controlled feeding study is to investigate the potential health benefits of a pecan-containing diet. The investigators hypothesize the chronic consumption of pecans will improve an array of biomarkers related to cardiovascular disease and type 2 diabetes risk, including indices of… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease Risk, Type 2 Diabetes Risk
- What is being tested?
- Pecan-containing diet and Nut-free diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men \& postmenopausal women, age 50 years and over
- BMI 25-35 kg/m2
- Waist/hip >0.8 for women and >0.9 for men
- Blood pressure between 120/80 and 159/99
Who cannot join
- Cigarette smoking and/or nicotine replacement use
- Individuals taking estrogen
- Use of cholesterol-lowering medications
- Use of blood pressure-lowering medications
- Regular use of any stomach acid-lowering medications, laxatives (including fiber supplements) or anti-diarrheal medications (prescription or over-the-counter [OTC])
- Cardiovascular (heart) disease
Show all 18Show fewer
- Gastrointestinal disease
- Kidney disease
- Endocrine disease: including diabetes, unstable thyroid disease
- Autoimmune disease: including rheumatoid arthritis, gout, lupus, HIV
- Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
- Systolic blood pressure > 159 mmHg and/or diastolic blood pressure > 99 mmHg
- Regular use of oral or injectable steroids
- Gain or loss of > 10% of body weight within previous 3 months; unwillingness to maintain your weight
- Regular daily intake of ≥ 2 alcoholic drinks
- Vegetarians
- Current allergy to any kind of nut
- Dietary supplement use, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
Official title: The Effect of Pecans on Biomarkers of Risk for Cardiovascular Disease and Diabetes: A Controlled Feeding Trial in Overweight/Obese Adults With Central Adiposity
The objective of this randomized, controlled feeding study is to investigate the potential health benefits of a pecan-containing diet. The investigators hypothesize the chronic consumption of pecans will improve an array of biomarkers related to cardiovascular disease and type 2 diabetes risk, including indices of oxidative stress, antioxidant activity, inflammation, endothelial function, and insulin resistance when compared with a control diet that is absent nuts.
- Conditions
- Cardiovascular Disease Risk, Type 2 Diabetes Risk
- Being tested
- Pecan-containing diet, Nut-free diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecan-containing dietOther
Also called Isocaloric diet containing 1.5 oz pecans per 2000 kcal per day for 28 days
Nut-free dietOther
Also called Isocaloric diet absent nuts and matched for total fat and fiber for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Pecan-containing diet | Active comparator | Test diet containing 1.5 oz pecans/2000 kcal/day for 28 days Receives: Other: Pecan-containing diet |
| Nut-free diet | Placebo comparator | Placebo diet containing no nuts or nut products, and identical in total fat and fiber as the test diet, for 28 days Receives: Other: Nut-free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biomarkers of oxidative stress compared with control diet
Measured: Baseline and 4 weeks
Change in biomarkers of inflammation compared with control diet
Measured: Baseline and 4 weeks.
Change in biomarkers of endothelial function compared with control diet
Measured: Baseline and 4 weeks.
Change in biomarkers of antioxidant activity compared with control diet
Measured: Baseline and 4 weeks
Change in biomarkers of insulin resistance compared with control diet
Measured: Baseline and 4 weeks
Secondary outcomes (2)
Change in blood pressure compared with control diet
Measured: Baseline and 4 weeks
Change in plasma lipid profile compared with control diet
Measured: Baseline and 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease RiskStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Pecan Shellers Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950806
- Sponsor's protocol ID
- IRB10998
- Status last verified
- Apr 2017
- First submitted
- 23 Sep 2013
- Last updated
- 25 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pecans on Biomarkers of Risk for Cardiovascular Disease and Diabetes: A Controlled Feeding Trial in Overweight/Obese Adults With Central Adiposity
- ClinicalTrials.gov ID
- NCT01950806
- Acronym / sponsor ID
- IRB10998
- Conditions
- Cardiovascular Disease Risk, Type 2 Diabetes Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Pecan Shellers Association
- Study start
- Jan 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 25 Sep 2013 (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 randomized, controlled feeding study is to investigate the potential health benefits of a pecan-containing diet. The investigators hypothesize the chronic consumption of pecans will improve an array of biomarkers related to cardiovascular disease and type 2 diabetes risk, including indices of oxidative stress, antioxidant activity, inflammation, endothelial function, and insulin resistance when compared with a control diet that is absent nuts.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pecan-containing diet | Active comparator | Other: Pecan-containing dietTest diet containing 1.5 oz pecans/2000 kcal/day for 28 days |
| Nut-free diet | Placebo comparator | Other: Nut-free dietPlacebo diet containing no nuts or nut products, and identical in total fat and fiber as the test diet, for 28 days |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men \& postmenopausal women, age 50 years and over
- BMI 25-35 kg/m2
- Waist/hip >0.8 for women and >0.9 for men
- Blood pressure between 120/80 and 159/99
Key exclusion criteria (18 listed)
- Cigarette smoking and/or nicotine replacement use
- Individuals taking estrogen
- Use of cholesterol-lowering medications
- Use of blood pressure-lowering medications
- Regular use of any stomach acid-lowering medications, laxatives (including fiber supplements) or anti-diarrheal medications (prescription or over-the-counter [OTC])
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 |
|---|---|---|
| Pecan-containing dietAlso: Isocaloric diet containing 1.5 oz pecans per 2000 kcal per day for 28 days | Other | Pecan-containing diet |
| Nut-free dietAlso: Isocaloric diet absent nuts and matched for total fat and fiber for 28 days. | Other | Nut-free diet |
Primary outcome
Change in biomarkers of oxidative stress compared with control diet
Time frame: Baseline and 4 weeks
Change in biomarkers of inflammation compared with control diet
Time frame: Baseline and 4 weeks.
Change in biomarkers of endothelial function compared with control diet
Time frame: Baseline and 4 weeks.
Change in biomarkers of antioxidant activity compared with control diet
Time frame: Baseline and 4 weeks
Change in biomarkers of insulin resistance compared with control diet
Time frame: Baseline and 4 weeks
2 secondary outcomes
Change in blood pressure compared with control diet
Time frame: Baseline and 4 weeks
Change in plasma lipid profile compared with control diet
Time frame: Baseline and 4 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 25 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pecan-containing diet and Nut-free diet in people with Cardiovascular Disease Risk and Type 2 Diabetes Risk, run by Tufts 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 4 inclusion and 18 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 25 Apr 2017. 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?
Change in biomarkers of oxidative stress compared with control diet (time frame: Baseline and 4 weeks). The study lists 5 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 25 Apr 2017.