Cardiovascular DiseasePhase 1NCT01405300
The Effects of Peanuts and Peanut Products on Glucose Control and Vascular Function
A Phase 1 study testing Peanut in people with Cardiovascular Disease, run by Penn State University at 1 site in United States.
Trial summary
Pilot study data have demonstrated that peanuts ameliorate the postprandial glucose and insulin response when incorporated into an acute high fat/high glucose meal. However, it is unclear whether acute consumption of peanuts can also influence vascular function. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Peanut
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2014
- Phase
- Phase 1
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-50 years of age
- LDL-C below 160 mg/dL
- Triglyceride below 350 mg/dL
- Blood pressure within normal ranges (below 140/90 mmHg)
- Not taking medication for elevated lipids, blood pressure or glucose
Who cannot join
- Allergies to peanuts or dairy products
- Known intolerance for high fat meals
- History of cardiovascular disease (CVD), kidney disease, diabetes or inflammatory diseases such as GI disorders and arthritis
- Use of non-steroidal anti-inflammatories or immunosuppressants
- Conditions requiring the use of steroids
- Use of medication or supplements for elevated lipids, blood pressure or glucose
Show all 10Show fewer
- Donation of blood or plasma during the study
- History of thyroid disease
- Women
- Lactose intolerance
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Pilot study data have demonstrated that peanuts ameliorate the postprandial glucose and insulin response when incorporated into an acute high fat/high glucose meal. However, it is unclear whether acute consumption of peanuts can also influence vascular function. This study will therefore evaluate the effects of acute peanut consumption on vascular function, glycemic control, and plasma lipids. The hypothesis is that that addition of peanuts to a high fat/high glucose meal will reduce the production of triglycerides, glucose, and improve endothelial function as measured by flow-mediated dilation (FMD).
- Conditions
- Cardiovascular Disease
- Being tested
- Control, Peanut
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
34.8 g dextrose, 150 g heavy whipping cream, 39g chocolate syrup, 15 g sunflower oil, 22 g safflower oil, 27 g powdered egg whites, 9.6 g of fiber supplement, water and crushed ice. It will deliver ~1200 kcal.
PeanutDietary supplement
34.8 g dextrose. 137 g heavy whipping cream, 39g chocolate syrup + 3 oz peanuts with skin. It will deliver ~1200 kcal.
| Study group | Role | What they receive |
|---|---|---|
| Peanut | Experimental | Not described Receives: Dietary Supplement: Peanut |
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Flow-Mediated Dilation at 4 hours postprandial
Measured: 0 min; 240 min
Secondary outcomes (4)
Change from baseline in oxidative stress over 4 hours postprandial
Measured: 0 min, 30 min, 60 min, 120 min, 240 min
Change from baseline in serum lipids over 4 hours postprandial
Measured: 0 min, 30 min, 60 min, 120 min, 240 min
Change from baseline in serum glucose over 4 hours postprandial
Measured: 0 min, 30 min, 60 min, 120 min, 240 min
Change from baseline in serum insulin over 4 hours postprandial
Measured: 0 min, 30 min, 60 min, 120 min, 240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2014
- Study completionJun 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 Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Peanut Institute
- Responsible party
- Sponsor
- Investigators
- Penny M Kris-Etherton, PhD, RD, Principal investigator, Penn State UniversityAnn C Skulas-Ray, PhD, Study director, Penn State UniversityXiaoran Liu, Study director, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405300
- Sponsor's protocol ID
- PKE PPNUT
- Status last verified
- Aug 2023
- First submitted
- 27 Jul 2011
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu X, Hill AM, West SG, Gabauer RM, McCrea CE, Fleming JA, Kris-Etherton PM. Acute Peanut Consumption Alters Postprandial Lipids and Vascular Responses in Healthy Overweight or Obese Men. J Nutr. 2017 May;147(5):835-840. doi: 10.3945/jn.116.246785. Epub 2017 Mar 29.
PubMed 28356431
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Peanuts and Peanut Products on Glucose Control and Vascular Function
- ClinicalTrials.gov ID
- NCT01405300
- Acronym / sponsor ID
- PKE PPNUT
- Conditions
- Cardiovascular Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Peanut Institute
- Study start
- Aug 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Jul 2011 (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.
Pilot study data have demonstrated that peanuts ameliorate the postprandial glucose and insulin response when incorporated into an acute high fat/high glucose meal. However, it is unclear whether acute consumption of peanuts can also influence vascular function. This study will therefore evaluate the effects of acute peanut consumption on vascular function, glycemic control, and plasma lipids. The hypothesis is that that addition of peanuts to a high fat/high glucose meal will reduce the production of triglycerides, glucose, and improve endothelial function as measured by flow-mediated dilation (FMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanut | Experimental | Dietary Supplement: Peanut |
| Control | Placebo comparator | Dietary Supplement: Control |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 20-50 years of age
- LDL-C below 160 mg/dL
- Triglyceride below 350 mg/dL
- Blood pressure within normal ranges (below 140/90 mmHg)
- Not taking medication for elevated lipids, blood pressure or glucose
Key exclusion criteria (10 listed)
- Allergies to peanuts or dairy products
- Known intolerance for high fat meals
- History of cardiovascular disease (CVD), kidney disease, diabetes or inflammatory diseases such as GI disorders and arthritis
- Use of non-steroidal anti-inflammatories or immunosuppressants
- Conditions requiring the use of steroids
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 |
|---|---|---|
| Control34.8 g dextrose, 150 g heavy whipping cream, 39g chocolate syrup, 15 g sunflower oil, 22 g safflower oil, 27 g powdered egg whites, 9.6 g of fiber supplement, water and crushed ice. It will deliver ~1200 kcal. | Dietary supplement | Control |
| Peanut34.8 g dextrose. 137 g heavy whipping cream, 39g chocolate syrup + 3 oz peanuts with skin. It will deliver ~1200 kcal. | Dietary supplement | Peanut |
Primary outcome
Change from baseline in Flow-Mediated Dilation at 4 hours postprandial
Time frame: 0 min; 240 min
4 secondary outcomes
Change from baseline in oxidative stress over 4 hours postprandial
Time frame: 0 min, 30 min, 60 min, 120 min, 240 min
Change from baseline in serum lipids over 4 hours postprandial
Time frame: 0 min, 30 min, 60 min, 120 min, 240 min
Change from baseline in serum glucose over 4 hours postprandial
Time frame: 0 min, 30 min, 60 min, 120 min, 240 min
Change from baseline in serum insulin over 4 hours postprandial
Time frame: 0 min, 30 min, 60 min, 120 min, 240 min
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 21 Aug 2023.
- Derived from this study: PubMed 28356431Liu X, Hill AM, West SG, Gabauer RM, McCrea CE, Fleming JA, Kris-Etherton PM. Acute Peanut Consumption Alters Postprandial Lipids and Vascular Responses in Healthy Overweight or Obese Men. J Nutr. 2017 May;147(5):835-840. doi: 10.3945/jn.116.246785. Epub 2017 Mar 29.
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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.
Penny M Kris-Etherton, PhD, RD principal investigator
Penn State University
Ann C Skulas-Ray, PhD study director
Penn State University
Xiaoran Liu study director
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Peanut in people with Cardiovascular Disease, run by Penn State 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 5 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 21 Aug 2023. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 from baseline in Flow-Mediated Dilation at 4 hours postprandial (time frame: 0 min; 240 min). 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 NCT01405300, 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 21 Aug 2023.