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CompletedNCT01173042PKEPEANUTUpdated Aug 21, 2023

Effects of Peanut Consumption on Postprandial Inflammation, Glucose and Triglycerides

A Phase 1 interventional study of Peanuts and Glucose and whipping cream in Cardiovascular Disease, sponsored by Penn State University. Completed at 1 site in United States. Open to male participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Penn State University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Cardiovascular Disease

Keywords

  • Overweight
  • Obese
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 6 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
6 participants (actual)

Study arms

  • Placebo comparator
    Control

    Shake containing heavy whipping cream, glucose and chocolate syrup

    Dietary Supplement: Glucose and whipping cream

  • Experimental
    Peanut

    Shake containing control (whipping cream, glucose and chocolate syrup) + 3oz of peanuts

    Dietary Supplement: Peanuts

  • Experimental
    Oil blend

    Shake containing control (heavy whipping cream, glucose and chocolate syrup) + oil blend (equivalent to fatty acids provided in 3oz peanuts)

    Dietary Supplement: Oil Blend

Interventions

  • Dietary supplementPeanuts

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

  • Dietary supplementGlucose and whipping cream

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

  • Dietary supplementOil Blend

    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

06

What researchers measure

Primary outcomes

  1. Serum C-reactive protein

    Time frame: 0min

  2. Serum C-reactive protein

    Time frame: 60 min

  3. Serum C-reactive protein

    Time frame: 120 min

  4. Serum C-reactive protein

    Time frame: 240 min

Secondary outcomes

  1. Serum Glucose

    Time frame: 0 min

  2. Serum Insulin

    Time frame: 0 min

  3. Serum Triglycerides

    Time frame: 0 min

  4. Serum Glucose

    Time frame: 60 min

  5. Serum Glucose

    Time frame: 120 min

  6. Serum Glucose

    Time frame: 240 min

  7. Serum Insulin

    Time frame: 60 min

  8. Serum Insulin

    Time frame: 120 min

  9. Serum Insulin

    Time frame: 240 min

  10. Serum Triglycerides

    Time frame: 60 min

  11. Serum Triglycerides

    Time frame: 120 min

  12. Serum Triglycerides

    Time frame: 240 min

07

Study locations

1 site
  • Penn State University
    University Park, Pennsylvania 16802, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01173042
Lead sponsor
Penn State University
Collaborators
The Peanut Institute
Responsible party
Sponsor
First posted
Jul 30, 2010
Start date
Aug 2009
Primary completion
Jan 2010
Completion
Feb 2010
Last update
Aug 21, 2023

Study contacts

Alison M Hill, Ph.D
principal investigator · Penn State University, Department of Nutritiontal Sciences
Penny M. Kris-Etherton, Ph.D
principal investigator · Penn State University, Department of Nutritional Sciences
Li Wang
study director · Penn State University, Department of Nutritional Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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