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Completed

NCT Number: NCT04056208

Pistachios Blood Sugar Control, Heart and Gut Health

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pistachio

Drug

Unsalted pistachios

Usual Care

Other

Advice and resources will be provided

Primary outcomes

  1. Fasting plasma glucose concentration

    Time frame: 12 weeks

    Fasting blood glucose (mg/dL)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

The Effect of Pistachios on Risk Factors for Cardiometabolic Disease in Individuals With Pre-diabetes: a Randomized, Cross-over Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 14, 2019
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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