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Pistachios Blood Sugar Control, Heart and Gut Health

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ClinicalTrials.gov Identifier: NCT04056208
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Penny, Penn State University

Tracking Information
First Submitted Date  ICMJE August 12, 2019
First Posted Date  ICMJE August 14, 2019
Last Update Posted Date December 19, 2020
Actual Study Start Date  ICMJE September 9, 2019
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
Fasting plasma glucose concentration [ Time Frame: 12 weeks ]
fasting blood glucose assessed by blood draw and expressed in mg/dL
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
Fasting plasma glucose [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
  • HbA1c [ Time Frame: 12 weeks ]
    HbA1c assessed by blood draw and expressed in micro IU/mL
  • Serum insulin concentration [ Time Frame: 12 weeks ]
    fasting serum insulin levels assessed by blood draw and expressed in micro IU/mL
  • Peripheral systolic and diastolic blood pressure [ Time Frame: 12 weeks ]
    Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical).
  • Central systolic and diastolic blood pressure [ Time Frame: 12 weeks ]
    Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical).
  • Carotid-femoral pulse wave velocity [ 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.
  • 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.
  • LDL cholesterol concentration [ Time Frame: 12 weeks ]
    Assessed using fasting blood draw
  • HDL cholesterol concentration [ Time Frame: 12 weeks ]
    Assessed using fasting blood draw
  • Total cholesterol concentration [ Time Frame: 12 weeks ]
    Assessed using fasting blood draw
  • Triglyceride concentration [ Time Frame: 12 weeks ]
    Assessed using fasting blood draw
  • 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.
  • waist circumference [ Time Frame: 12 weeks ]
    Measured 10 cm above the navel
  • body weight [ Time Frame: 12 weeks ]
    Assessed using calibrated scale in Clinical Research Center
  • Diet quality: Healthy Eating Index 2015 [ Time Frame: 12 weeks ]
    Assessed using the Healthy Eating Index 2015
  • Change in the composition of the gut microbiome [ Time Frame: 12 weeks ]
    microbiome composition assessed using fecal collection kit
Original Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
  • HbA1c [ Time Frame: 12 weeks ]
  • Serum insulin [ Time Frame: 12 weeks ]
  • Peripheral systolic and diastolic blood pressure [ Time Frame: 12 weeks ]
  • Central systolic and diastolic blood pressure [ Time Frame: 12 weeks ]
  • Carotid-femoral pulse wave velocity [ Time Frame: 12 weeks ]
  • 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.
  • LDL cholesterol [ Time Frame: 12 weeks ]
  • HDL cholesterol [ Time Frame: 12 weeks ]
  • Total cholesterol [ Time Frame: 12 weeks ]
  • Triglyerides [ Time Frame: 12 weeks ]
  • HOMA-IR [ Time Frame: 12 weeks ]
  • waist circumference [ Time Frame: 12 weeks ]
  • body weight [ Time Frame: 12 weeks ]
  • Diet quality: Healthy Eating Index 2015 [ Time Frame: 12 weeks ]
    Assessed using the Healthy Eating Index 2015
  • Change in the composition of the gut microbiome [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pistachios Blood Sugar Control, Heart and Gut Health
Official Title  ICMJE The Effect of Pistachios on Risk Factors for Cardiometabolic Disease in Individuals With Pre-diabetes: a Randomized, Cross-over Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Crossover assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Type 2 Diabetes
  • Cardiovascular Diseases
Intervention  ICMJE
  • Drug: Pistachio
    Unsalted pistachios
  • Other: Usual care
    Advice and resources will be provided
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Pistachio
  • 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.
    Intervention: Other: Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2019)
59
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Penny M Kris-Etherton, PhD 8145714779 pmk3@psu.edu
Contact: Julie Arnold 814-863-8305 jqr9@psu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04056208
Other Study ID Numbers  ICMJE PKE Pistachio
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Penny, Penn State University
Study Sponsor  ICMJE Penn State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Penn State University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP