AgingNCT04385537
The Ability of Pecan Consumption to Improve Vascular Function and Reduce Chronic Disease Risk in Aging Adults
A study testing PECAN in people with Aging, run by University of Georgia at 1 site in United States.
Trial summary
Background: To date, there are no published studies on the effects of pecans on vascular function following a high-fat meal. Purpose: To examine the impact of daily pecan consumption for a 4-week period on vascular health and other markers of cardiovascular disease risk in aging adults. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- PECAN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2020to 16 Apr 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and postmenopausal women (without menses for 1 yr and follicle stimulating hormone > 30 IU/mL) between the ages of 50-75y
- Body mass indexes (BMI) between 18-34.9kg/m2
Who cannot join
- Nut consumption >2 servings/week or tree nut butter consumption >3 servings/week
- Pre-menopausal and menopausal women, hormone replacement therapy if less than 2 years
- Regularly exercise more than 3 h/week
- Weight gain or loss more than 5% of their body weight in the past 3 months
- Plans to begin a weight loss/exercise regimen during the trial
- Gastrointestinal surgeries, conditions or disorders
Show all 24Show fewer
- History of medical or surgical events that could affect swallowing
- Chronic or metabolic diseases
- Previous MI, stroke, or cancer
- Fasting blood glucose levels greater than 126 mg/dL
- Blood pressure greater than 180/120 mmHg
- Medication use affecting digestion and absorption, metabolism
- Lipid-lowering medications
- Medications for diabetes, depression, or ADD/ADHD
- Regular use of medications known to affect endothelial function or blood vessel tone
- Blood pressure medication and steroid/hormone therapies
- Individuals on a medically prescribed or special diet
- Individuals with food allergies to foods specifically in the study
- Excessively use alcohol (greater than 3 drinks/d for men; greater than 2 drinks/d for women)
- Tobacco or nicotine use
- Individuals taking fish oil and omega-3 fatty acid supplements
- Significant head trauma or brain surgery
- A score >26 on the Beck's Depression Inventory II (BDI-II)
- A score <24 on the Mini-Mental State Examination (MMSE) will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Georgia- Department of Foods and Nutrition
Athens, Georgia, 30605
About this study
Background: To date, there are no published studies on the effects of pecans on vascular function following a high-fat meal.
Purpose: To examine the impact of daily pecan consumption for a 4-week period on vascular health and other markers of cardiovascular disease risk in aging adults.
Read the detailed description
This will be a randomized, controlled trial in men and postmenopausal women (50-75y). Subjects will be randomized into one of the two study groups: a control group (CON) following their usual diet, or intervention group (PECAN) following their usual diet but also consuming 68g/day of pecans as a snack.
There will be 3 visits: A Screening visit and a baseline and post-diet intervention visit (4-weeks). Anthropometrics, questionnaires, a fasting blood sample, and fasting vascular measures will be collected at each visit. Subjects will participate in a saturated fatty acid meal challenge in which additional blood, vascular measurements will be collected.
Hypothesis: Daily pecan consumption will result in improved fasting blood lipids, vascular measures, antioxidant status, and appetite compared to the control group. Additionally, also the PECAN group will result in improved postprandial blood lipids and vascular measures compared to the control group.
- Conditions
- Aging
- Being tested
- PECAN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECANDietary supplement
Raw pecan halves without other changes to their habitual diet.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in this group avoid all nuts for 4-weeks |
| PECAN | Experimental | Participants in this group consume 68 g of pecans/d with no other changes to their habitual diet and avoid all other nuts. Receives: Dietary Supplement: PECAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting and postprandial Flow-Mediated Dilation from baseline to 4 weeks
Flow-Mediated Dilation %
Measured: Baseline and 4 weeks
Change in fasting and postprandial vessel diameter from baseline to 4 weeks
baseline diameter (mm) and peak dilation (mm)
Measured: Baseline and 4 weeks
Change in fasting and postprandial reactive hyperemia velocity from baseline to 4 weeks
Baseline velocity (cm/s) and reactive hyperemia velocity (cm/s)
Measured: Baseline and 4 weeks
Change in fasting and postprandial shear rate from baseline to 4 weeks
baseline shear rate (sec.-1) and reactive hyperemia shear rate (sec.-1)
Measured: Baseline and 4 weeks
Change in fasting and postprandial Continuous-Wave Near-Infrared Spectrometry from baseline to 4 weeks
O2 desaturation rate (%.sec-1), and O2 resaturation rate (%.sec-1)
Measured: Baseline and 4 weeks
Secondary outcomes (13)
Change in fasting blood lipids from baseline to 4 weeks
Total cholesterol (mg/dL), high-density lipoprotein (HDL) cholesterol (mg/dL), triglycerides (mg/dL), low-density lipoprotein (LDL) cholesterol (mg/dL), apolipoprotein B (mg/dL)
Measured: Baseline and 4 weeks
Change in baseline weight at 4 weeks
weight (kg)
Measured: Baseline and 4 weeks
Change in baseline waist and hip circumference
waist and hip circumference (cm)
Measured: Baseline and 4 weeks
Change in blood pressure from baseline to 4 weeks
Systolic and Diastolic Blood Pressure (mm Hg)
Measured: Baseline and 4 weeks
Change in baseline total body fat percentage at 4 weeks
total body fat percentage (%)
Measured: Baseline and 4 weeks
Change in fasting and postprandial insulin from baseline to 4 weeks
Insulin (uU/mL)
Measured: Baseline and 4 weeks
Change in fasting and postprandial antioxidants from baseline to 4 weeks
Total antioxidant capacity (uM trolox equivalents) measured via Oxygen Radical Absorbance Capacity (ORAC)
Measured: Baseline and 4 weeks
Change in fasting and postprandial lipid peroxidation from baseline to 4 weeks
Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay.
Measured: Baseline and 4 weeks
Change in fasting inflammation from baseline to 4 weeks
Interleukin-6 (pg/mL), C-reactive Protein (pg/mL), Tumor Necrosis Factor-α (pg/mL), Plasminogen Activator-1 (pg/mL)
Measured: Baseline and 4 weeks
Change in fasting and postprandial glucose and triglycerides from baseline to 4 weeks
Glucose (mg/dL) and triglycerides (mg/dL)
Measured: Baseline and 4 weeks
Change in fasting and postprandial peptide YY, cholecystokinin (CCK), and ghrelin from baseline to 4 weeks
Peptide YY (pg/mL), CCK (pg/mL), ghrelin (pg/mL)
Measured: Baseline and 4 weeks
Change in fasting and postprandial non-esterified free fatty acids (NEFA) from baseline to 4 weeks
NEFA (mEq/L)
Measured: Baseline and 4 weeks
Change in fasting and postprandial hunger and satiety from baseline to 4 weeks
Hunger, fullness, prospective consumption, and desire to eat measured via a Visual Analog Scale (VAS) (mm). The range of scores on the continuous VAS is between 0mm (no hunger, fullness, prospective consumption and desire to eat) and 100mm (the greatest feeling of hunger, fullness, prospective consumption and desire to eat)
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 posted13 May 2020
- Study start17 Sep 2020
- Primary completion16 Apr 2022
- Study completion16 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- American Pecan Council
- Responsible party
- Principal investigator, Jamie Cooper, PhD, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385537
- Sponsor's protocol ID
- PROJECT00001978
- Status last verified
- May 2022
- First submitted
- 30 Apr 2020
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is to share group averages through publication.
Publications
Cogan B, Pearson RC, Jenkins NT, Paton CM, Cooper JA. A 4-Week Pecan-Enriched Diet Improves Postprandial Lipid Peroxidation in Aging Adults. J Med Food. 2023 Sep;26(9):654-662. doi: 10.1089/jmf.2023.0036. Epub 2023 Aug 28.
PubMed 37638838Cogan B, Pearson RC, Jenkins NT, Paton CM, Cooper JA. A pecan-enriched diet reduced postprandial appetite intensity and enhanced peptide YY secretion: A randomized control trial. Clin Nutr ESPEN. 2023 Aug;56:25-35. doi: 10.1016/j.clnesp.2023.05.002. Epub 2023 May 8.
PubMed 37344080Cogan B, Pearson RC, Paton CM, Jenkins NT, Cooper JA. Pecan-enriched diet improves cholesterol profiles and enhances postprandial microvascular reactivity in older adults. Nutr Res. 2023 Mar;111:44-58. doi: 10.1016/j.nutres.2023.01.001. Epub 2023 Jan 31.
PubMed 36822079
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of Pecan Consumption to Improve Vascular Function and Reduce Chronic Disease Risk in Aging Adults
- ClinicalTrials.gov ID
- NCT04385537
- Acronym / sponsor ID
- PROJECT00001978
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- American Pecan Council
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 16 Apr 2022 (actual)
- Study completion
- 16 Apr 2022 (actual)
- First posted
- 13 May 2020 (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.
Background: To date, there are no published studies on the effects of pecans on vascular function following a high-fat meal.
Purpose: To examine the impact of daily pecan consumption for a 4-week period on vascular health and other markers of cardiovascular disease risk in aging adults.
Detailed description
This will be a randomized, controlled trial in men and postmenopausal women (50-75y). Subjects will be randomized into one of the two study groups: a control group (CON) following their usual diet, or intervention group (PECAN) following their usual diet but also consuming 68g/day of pecans as a snack.
There will be 3 visits: A Screening visit and a baseline and post-diet intervention visit (4-weeks). Anthropometrics, questionnaires, a fasting blood sample, and fasting vascular measures will be collected at each visit. Subjects will participate in a saturated fatty acid meal challenge in which additional blood, vascular measurements will be collected.
Hypothesis: Daily pecan consumption will result in improved fasting blood lipids, vascular measures, antioxidant status, and appetite compared to the control group. Additionally, also the PECAN group will result in improved postprandial blood lipids and vascular measures compared to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in this group avoid all nuts for 4-weeks |
| PECAN | Experimental | Dietary Supplement: PECANParticipants in this group consume 68 g of pecans/d with no other changes to their habitual diet and avoid all other nuts. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and postmenopausal women (without menses for 1 yr and follicle stimulating hormone > 30 IU/mL) between the ages of 50-75y
- Body mass indexes (BMI) between 18-34.9kg/m2
Key exclusion criteria (24 listed)
- Nut consumption >2 servings/week or tree nut butter consumption >3 servings/week
- Pre-menopausal and menopausal women, hormone replacement therapy if less than 2 years
- Regularly exercise more than 3 h/week
- Weight gain or loss more than 5% of their body weight in the past 3 months
- Plans to begin a weight loss/exercise regimen during the trial
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 |
|---|---|---|
| PECANRaw pecan halves without other changes to their habitual diet. | Dietary supplement | PECAN |
Primary outcome
Change in fasting and postprandial Flow-Mediated Dilation from baseline to 4 weeks
Time frame: Baseline and 4 weeks
Flow-Mediated Dilation %
Change in fasting and postprandial vessel diameter from baseline to 4 weeks
Time frame: Baseline and 4 weeks
baseline diameter (mm) and peak dilation (mm)
Change in fasting and postprandial reactive hyperemia velocity from baseline to 4 weeks
Time frame: Baseline and 4 weeks
Baseline velocity (cm/s) and reactive hyperemia velocity (cm/s)
Change in fasting and postprandial shear rate from baseline to 4 weeks
Time frame: Baseline and 4 weeks
baseline shear rate (sec.-1) and reactive hyperemia shear rate (sec.-1)
Change in fasting and postprandial Continuous-Wave Near-Infrared Spectrometry from baseline to 4 weeks
Time frame: Baseline and 4 weeks
O2 desaturation rate (%.sec-1), and O2 resaturation rate (%.sec-1)
13 secondary outcomes
Change in fasting blood lipids from baseline to 4 weeks
Time frame: Baseline and 4 weeks
Change in baseline weight at 4 weeks
Time frame: Baseline and 4 weeks
Change in baseline waist and hip circumference
Time frame: Baseline and 4 weeks
Change in blood pressure from baseline to 4 weeks
Time frame: Baseline and 4 weeks
Change in baseline total body fat percentage at 4 weeks
Time frame: Baseline and 4 weeks
Change in fasting and postprandial insulin from baseline to 4 weeks
Time frame: Baseline and 4 weeks
Change in fasting and postprandial antioxidants from baseline to 4 weeks
Time frame: Baseline and 4 weeks
Change in fasting and postprandial lipid peroxidation from baseline to 4 weeks
Time frame: Baseline and 4 weeks
Change in fasting inflammation from baseline to 4 weeks
Time frame: Baseline and 4 weeks
Change in fasting and postprandial glucose and triglycerides from baseline to 4 weeks
Time frame: Baseline and 4 weeks
Change in fasting and postprandial peptide YY, cholecystokinin (CCK), and ghrelin from baseline to 4 weeks
Time frame: Baseline and 4 weeks
Change in fasting and postprandial non-esterified free fatty acids (NEFA) from baseline to 4 weeks
Time frame: Baseline and 4 weeks
Change in fasting and postprandial hunger and satiety from baseline to 4 weeks
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 24 May 2022.
- Derived from this study: PubMed 37638838Cogan B, Pearson RC, Jenkins NT, Paton CM, Cooper JA. A 4-Week Pecan-Enriched Diet Improves Postprandial Lipid Peroxidation in Aging Adults. J Med Food. 2023 Sep;26(9):654-662. doi: 10.1089/jmf.2023.0036. Epub 2023 Aug 28.
- Derived from this study: PubMed 37344080Cogan B, Pearson RC, Jenkins NT, Paton CM, Cooper JA. A pecan-enriched diet reduced postprandial appetite intensity and enhanced peptide YY secretion: A randomized control trial. Clin Nutr ESPEN. 2023 Aug;56:25-35. doi: 10.1016/j.clnesp.2023.05.002. Epub 2023 May 8.
- Derived from this study: PubMed 36822079Cogan B, Pearson RC, Paton CM, Jenkins NT, Cooper JA. Pecan-enriched diet improves cholesterol profiles and enhances postprandial microvascular reactivity in older adults. Nutr Res. 2023 Mar;111:44-58. doi: 10.1016/j.nutres.2023.01.001. Epub 2023 Jan 31.
- Individual participant dataSharing planned: No. The plan is to share group averages through publication.
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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 in people with Aging, run by University of Georgia 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 2 inclusion and 24 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 24 May 2022. 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 fasting and postprandial Flow-Mediated Dilation from baseline to 4 weeks (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?
On the ClinicalTrials.gov record for NCT04385537, which also lists 3 linked publications.
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 24 May 2022.