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Cardiovascular DiseasePhase 1PKEPEANUTNCT01173042

Effects of Peanut Consumption on Postprandial Inflammation, Glucose and Triglycerides

A Phase 1 study testing Peanuts, Glucose and whipping cream and Oil Blend in people with Cardiovascular Disease, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot study will investigate the effects of acute peanut consumption on markers of inflammation, triglycerides and glucose. The hypothesis is that a high glucose/SFA meal will increase postprandial production of the inflammatory marker, C-reactive protein (CRP), and that the addition of peanuts to the control… Read more about this study

Who is it for?
Ages 30 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Cardiovascular Disease
What is being tested?
Peanuts, Glucose and whipping cream and Oil Blend
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6 participants
Where
1 siteUnited States
Study dates
Aug 2009to Feb 2010
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 30 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • BMI >28
  • LDL_C below 130 mg/dl
  • TG below 350 mg/dl
  • Blood pressure within normal ranges (below 140/90 mmHg)

Who cannot join

  • Smoking
  • Allergies to peanuts or dairy products
  • Known intolerance for high fat meals
  • History of CVD, kidney disease, diabetes or inflammatory disease
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Penn State University

    University Park, Pennsylvania, 16802

Other trials in United States

About this study

Official title: Pilot Study of the Effect of Peanut Consumption on Postprandial Inflammatory Status, Glucose and Triglycerides

This pilot study will investigate the effects of acute peanut consumption on markers of inflammation, triglycerides and glucose. The hypothesis is that a high glucose/SFA meal will increase postprandial production of the inflammatory marker, C-reactive protein (CRP), and that the addition of peanuts to the control meal will reduce the production of CRP, as well as triglycerides and glucose.

Read the detailed description

Previous research has demonstrated that a single meal high in saturated fatty acids (SFA) and glucose can induce increases in IL-6, TNF-α and CRP in abdominally obese and diabetic subjects. As over two-thirds of the U.S. population is overweight or obese, it is important to identify foods that can attenuate postprandial increases in lipids, glucose and inflammation in this population. Therefore, the purpose of the pilot study is to determine whether a high SFA / high glucose control meal will induce an acute inflammatory response in overweight individuals, and whether the addition of peanuts to this meal will ameliorate this response. To ensure that these effects are due to peanuts, and not to the increase in total fat, we will compare this response to another test meal that includes an oil blend with a similar fatty acid composition to peanuts.

Being tested
Peanuts, Glucose and whipping cream, Oil Blend
Keywords
Overweight, Obese
Medical subject headings
Cardiovascular Diseases, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PeanutsDietary supplement

    Shake containing 3.0oz of peanuts (including skin) + control (heavy whipping cream, glucose and chocolate syrup)

  • Glucose and whipping creamDietary supplement

    An oral liquid glucose (75g) and fat (high saturated fat from 60g heavy whipping cream) load. Chocolate syrup is added for flavor.

  • Oil BlendDietary supplement

    Shake containing an oil blend (sunflower, sesame, olive and palm oils) + control (heavy whipping cream, glucose and chocolate syrup). The amount of oil added to the control will provide an equivalent amount of fat to that provided in 3 oz (85g) of peanuts

Study groups in NCT01173042
Study groupRoleWhat they receive
ControlPlacebo comparatorShake containing heavy whipping cream, glucose and chocolate syrup
Receives: Dietary Supplement: Glucose and whipping cream
PeanutExperimentalShake containing control (whipping cream, glucose and chocolate syrup) + 3oz of peanuts
Receives: Dietary Supplement: Peanuts
Oil blendExperimentalShake containing control (heavy whipping cream, glucose and chocolate syrup) + oil blend (equivalent to fatty acids provided in 3oz peanuts)
Receives: Dietary Supplement: Oil Blend

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum C-reactive protein

    Measured: 0min

  2. Serum C-reactive protein

    Measured: 60 min

  3. Serum C-reactive protein

    Measured: 120 min

  4. Serum C-reactive protein

    Measured: 240 min

Secondary outcomes (12)

  1. Serum Glucose

    Measured: 0 min

  2. Serum Insulin

    Measured: 0 min

  3. Serum Triglycerides

    Measured: 0 min

  4. Serum Glucose

    Measured: 60 min

  5. Serum Glucose

    Measured: 120 min

  6. Serum Glucose

    Measured: 240 min

  7. Serum Insulin

    Measured: 60 min

  8. Serum Insulin

    Measured: 120 min

  9. Serum Insulin

    Measured: 240 min

  10. Serum Triglycerides

    Measured: 60 min

  11. Serum Triglycerides

    Measured: 120 min

  12. Serum Triglycerides

    Measured: 240 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2010 (estimated)
  2. Study startAug 2009
  3. Primary completionJan 2010
  4. Study completionFeb 2010

Resources

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01173042
Sponsor's protocol ID
PKE105
Acronym
PKEPEANUT
Status last verified
Aug 2023
First submitted
13 Apr 2010
Last updated
21 Aug 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Peanuts, Glucose and whipping cream and Oil Blend 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 4 inclusion and 7 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?

Serum C-reactive protein (time frame: 0min). The study lists 4 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 NCT01173042.

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.

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