Clinical trial NCT04056208: Pistachios Blood Sugar Control, Heart and Gut Health
Official title: The Effect of Pistachios on Risk Factors for Cardiometabolic Disease in Individuals With Pre-diabetes: a Randomized, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Cardiovascular Diseases
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover assignment
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Fasting plasma glucose concentration
timeFrame: 12 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 12 weeks
measure: Serum insulin concentration (mIU/L)
timeFrame: 12 weeks
measure: Peripheral systolic and diastolic blood pressure (mm Hg)
timeFrame: 12 weeks
measure: Central systolic and diastolic blood pressure (mm Hg)
timeFrame: 12 weeks
measure: Carotid-femoral pulse wave velocity (m/s)
timeFrame: 12 weeks
measure: Augmentation Index (%)
timeFrame: 12 weeks
measure: LDL cholesterol concentration (mg/dL)
timeFrame: 12 weeks
measure: HDL cholesterol concentration
timeFrame: 12 weeks
measure: Total cholesterol concentration
timeFrame: 12 weeks
measure: Triglyceride concentration
timeFrame: 12 weeks
measure: HOMA-IR
timeFrame: 12 weeks
measure: waist circumference (cm)
timeFrame: 12 weeks
measure: body weight (lbs)
timeFrame: 12 weeks
measure: Diet quality: Healthy Eating Index 2015
timeFrame: 12 weeks
measure: Change in the composition of the gut microbiome
timeFrame: 12 weeks
Other outcomes:
Locations:
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
References: