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Pistachios Blood Sugar Control, Heart and Gut Health

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ClinicalTrials.gov Identifier: NCT04056208
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover assigment
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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Fasting plasma glucose [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 12 weeks ]
  2. Serum insulin [ Time Frame: 12 weeks ]
  3. Peripheral systolic and diastolic blood pressure [ Time Frame: 12 weeks ]
  4. Central systolic and diastolic blood pressure [ Time Frame: 12 weeks ]
  5. Carotid-femoral pulse wave velocity [ Time Frame: 12 weeks ]
  6. Augmentation Index (%) [ Time Frame: 12 weeks ]
    A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness.

  7. LDL cholesterol [ Time Frame: 12 weeks ]
  8. HDL cholesterol [ Time Frame: 12 weeks ]
  9. Total cholesterol [ Time Frame: 12 weeks ]
  10. Triglyerides [ Time Frame: 12 weeks ]
  11. HOMA-IR [ Time Frame: 12 weeks ]
  12. waist circumference [ Time Frame: 12 weeks ]
  13. body weight [ Time Frame: 12 weeks ]
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 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

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: Kristina S Petersen 8148638622 kup63@psu.edu
Contact: Julie Arnold 814-863-8305 jqr9@psu.edu

Sponsors and Collaborators
Penn State University

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Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT04056208     History of Changes
Other Study ID Numbers: PKE Pistachio
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
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