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Pistachios Blood Sugar Control, Heart and Gut Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04056208
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Penny, Penn State University

Study Description
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Brief Summary:
A two-period randomized crossover study will be conducted to evaluate the effect of nighttime pistachio consumption (i.e., after dinner and before sleep) on fasting blood sugar levels, longer-term blood sugar control, and risk factors for heart disease. This study will also investigate how pistachios affects gut health.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Cardiovascular Diseases Drug: Pistachio Other: Usual care Phase 2

Detailed Description:
A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 12 weeks followed by a minimum 4-week wash-out period. During the pistachio treatment, participants will consume two ounces per day (57 g) of pistachios as an evening snack. During the control phase subjects will be given advice to consume 1-2 exchanges of carbohydrate as an evening snack, which is consistent with usual care. Markers of glycemic control, cardiovascular risk factors and gut health will be assessed at the beginning and the end of each treatment period.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Pistachios on Risk Factors for Cardiometabolic Disease in Individuals With Pre-diabetes: a Randomized, Cross-over Study
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Evening Pistachio Consumption
Participants will consume two ounces per day (57 g) of pistachios as an evening snack (i.e., after dinner and before sleep).
 Drug: Pistachio
Unsalted pistachios
Active Comparator: Usual care
Advice to consume a snack that contains 1-2 exchanges (15-30 g of carbohydrate) as an evening snack - this is consistent with the current standard of care for people with impaired fasting glucose.
 Other: Usual care
Advice and resources will be provided


Outcome Measures
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Primary Outcome Measures :
  1. Fasting plasma glucose concentration [ Time Frame: 12 weeks ]
    Fasting blood glucose (mg/dL)


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 12 weeks ]
    HbA1c (%) will be assessed at the beginning and end of each treatment period

  2. Serum insulin concentration (mIU/L) [ Time Frame: 12 weeks ]
    fasting serum insulin levels assessed by blood draw

  3. Peripheral systolic and diastolic blood pressure (mm Hg) [ Time Frame: 12 weeks ]
    Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical).

  4. Central systolic and diastolic blood pressure (mm Hg) [ Time Frame: 12 weeks ]
    Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical).

  5. Carotid-femoral pulse wave velocity (m/s) [ Time Frame: 12 weeks ]
    A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness.

  6. Augmentation Index (%) [ Time Frame: 12 weeks ]
    A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness.

  7. LDL cholesterol concentration (mg/dL) [ Time Frame: 12 weeks ]
    Assessed using fasting blood draw

  8. HDL cholesterol concentration [ Time Frame: 12 weeks ]
    Assessed using fasting blood draw

  9. Total cholesterol concentration [ Time Frame: 12 weeks ]
    Assessed using fasting blood draw

  10. Triglyceride concentration [ Time Frame: 12 weeks ]
    Assessed using fasting blood draw

  11. HOMA-IR [ Time Frame: 12 weeks ]
    Assessed using fasting blood draw and standardized HOMA-IR calculation. Fasting plasma glucose multiplied by fasting plasma insulin divided by 405.

  12. waist circumference (cm) [ Time Frame: 12 weeks ]
    Measured 10 cm above the navel

  13. body weight (lbs) [ Time Frame: 12 weeks ]
    Assessed using calibrated scale in Clinical Research Center

  14. Diet quality: Healthy Eating Index 2015 [ Time Frame: 12 weeks ]
    Assessed using the Healthy Eating Index 2015

  15. Change in the composition of the gut microbiome [ Time Frame: 12 weeks ]
    microbiome composition assessed using fecal collection kit


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI ≥25 and ≤45 kg/m2
  • Fasting plasma glucose 100 - 125 mg/dL
  • non-Smoking

Exclusion Criteria:

  • Diagnosed diabetes or fasting glucose >126 mg/dl
  • Systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
  • Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
  • Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
  • Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
  • Women who are pregnant, lactating, planning to become pregnant or have given birth in the past year
  • Weight loss of >=10% of body weight within the 6 months prior to enrolling in the study
  • Smoking or use of any tobacco products
  • Allergy/intolerance/sensitive to pistachios
  • Consumption of >14 alcoholic drinks/week
  • Shift-workers and those who cannot consume a snack in the evening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056208


Contacts
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Contact: Penny M Kris-Etherton, PhD 8145714779 pmk3@psu.edu
Contact: Julie Arnold 814-863-8305 jqr9@psu.edu

Locations
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United States, Pennsylvania
Pennsylvania State University Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Kristina S Petersen, PhD    814-863-8622    kup63@psu.edu   
Contact: Terry Riley    814 863 8056    tmr359@psu.edu   
Sponsors and Collaborators
Penn State University
More Information
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Responsible Party: Penny, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT04056208    
Other Study ID Numbers: PKE Pistachio
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cardiovascular Diseases