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Clinical Trial Details

Trial ID: L4875
Source ID: NCT04056208
Associated Drug: Pistachio
Title: Pistachios Blood Sugar Control, Heart and Gut Health
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Cardiovascular Diseases
Interventions: DRUG: Pistachio|OTHER: Usual care
Outcome Measures: Primary: Fasting plasma glucose concentration, Fasting blood glucose (mg/dL), 12 weeks | Secondary: HbA1c, HbA1c (%) will be assessed at the beginning and end of each treatment period, 12 weeks|Serum insulin concentration (mIU/L), fasting serum insulin levels assessed by blood draw, 12 weeks|Peripheral systolic and diastolic blood pressure (mm Hg), Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)., 12 weeks|Central systolic and diastolic blood pressure (mm Hg), Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)., 12 weeks|Carotid-femoral pulse wave velocity (m/s), A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness., 12 weeks|Augmentation Index (%), A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness., 12 weeks|LDL cholesterol concentration (mg/dL), Assessed using fasting blood draw, 12 weeks|HDL cholesterol concentration, Assessed using fasting blood draw, 12 weeks|Total cholesterol concentration, Assessed using fasting blood draw, 12 weeks|Triglyceride concentration, Assessed using fasting blood draw, 12 weeks|HOMA-IR, Assessed using fasting blood draw and standardized HOMA-IR calculation. Fasting plasma glucose multiplied by fasting plasma insulin divided by 405., 12 weeks|waist circumference (cm), Measured 10 cm above the navel, 12 weeks|body weight (lbs), Assessed using calibrated scale in Clinical Research Center, 12 weeks|Diet quality: Healthy Eating Index 2015, Assessed using the Healthy Eating Index 2015, 12 weeks|Change in the composition of the gut microbiome, microbiome composition assessed using fecal collection kit, 12 weeks
Sponsor/Collaborators: Sponsor: Penn State University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 66
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2019-09-09
Completion Date: 2022-11-17
Results First Posted:
Last Update Posted: 2023-08-18
Locations: Pennsylvania State University, University Park, Pennsylvania, 16802, United States
URL: https://clinicaltrials.gov/show/NCT04056208