Pistachios Blood Sugar Control, Heart and Gut Health
- Conditions
- Cardiovascular DiseasesType 2 Diabetes
- Interventions
- Other: Usual care
- Registration Number
- NCT04056208
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- BMI ≥25 and ≤45 kg/m2
- Fasting plasma glucose 100 - 125 mg/dL
- non-Smoking
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Usual care 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. Evening Pistachio Consumption Pistachio Participants will consume two ounces per day (57 g) of pistachios as an evening snack (i.e., after dinner and before sleep).
- Primary Outcome Measures
Name Time Method Fasting plasma glucose concentration 12 weeks Fasting blood glucose (mg/dL)
- Secondary Outcome Measures
Name Time Method Central systolic and diastolic blood pressure (mm Hg) 12 weeks Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical).
Peripheral systolic and diastolic blood pressure (mm Hg) 12 weeks Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical).
Serum insulin concentration (mIU/L) 12 weeks fasting serum insulin levels assessed by blood draw
Carotid-femoral pulse wave velocity (m/s) 12 weeks A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness.
body weight (lbs) 12 weeks Assessed using calibrated scale in Clinical Research Center
Diet quality: Healthy Eating Index 2015 12 weeks Assessed using the Healthy Eating Index 2015
Change in the composition of the gut microbiome 12 weeks microbiome composition assessed using fecal collection kit
waist circumference (cm) 12 weeks Measured 10 cm above the navel
HDL cholesterol concentration 12 weeks Assessed using fasting blood draw
Total cholesterol concentration 12 weeks Assessed using fasting blood draw
Triglyceride concentration 12 weeks Assessed using fasting blood draw
HbA1c 12 weeks HbA1c (%) will be assessed at the beginning and end of each treatment period
LDL cholesterol concentration (mg/dL) 12 weeks Assessed using fasting blood draw
Augmentation Index (%) 12 weeks A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness.
HOMA-IR 12 weeks Assessed using fasting blood draw and standardized HOMA-IR calculation. Fasting plasma glucose multiplied by fasting plasma insulin divided by 405.
Trial Locations
- Locations (1)
Pennsylvania State University
🇺🇸University Park, Pennsylvania, United States