Trial | NCT01441921  Report issue

Official Title

Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pistachios ...

  • Study Participants

    50
Hypothesis: Chronic intake of pistachios improves glucose metabolism and insulin resistance status thus contributing to decrease the risk of type 2 diabetes mellitus and its associated abnormalities.
In free-living overweight or obese adult with impaired fasting glucose or impaired glucose tolerance we will compare the effects of a pistachio-rich diet or a Mediterranean Diet on:

Fasting glucose levels, hemoglobin A1c, insulin, C peptide, HOMA IR, advanced glycation end products and soluble receptor of advanced glycation-end products.
Peripheral haemostatic parameters.
Plasma inflammatory markers.
Lymphocyte expression of toll-like receptors, C peptide, resistin and interleukin-6 in peripheral leukocytes.
Lymphocyte glucose transport and expression of glucose transporter 4 in peripheral blood leukocytes.
Platelet function including platelet number, mean platelet volume, platelet factor 4 levels and urinary 11-dehydro-thromboxane B2.
Study Started
Sep 30
2011
Primary Completion
Sep 30
2016
Study Completion
Sep 30
2017
Last Update
Feb 11
2019

Dietary Supplement Pistachios

Participants are randomised crossover clinical trial of 4-months trials separated by a 2-week washout period. Total duration of intervention and follow-up is nine months.

Other control diet

Participants are randomised crossover clinical trial of 4-months trials separated by a 2-week washout period. Total duration of intervention and follow-up is nine months.

Control diet Active Comparator

Low-fat normocaloric diet (30% fat, 55% carbohydrates, 15% proteins)

Pistachio diet Experimental

Diet supplemented with 2 ounces of pistachio (35% fat, 50% carbohydrates adn 15% protein)

Criteria 

Inclusion Criteria:

BMI less than 35 kg/m2.
Fasting plasma glucose levels between 100 and 125 mg/dl or
Oral glucose tolerance test of 140 to 199 mg/dl.

Exclusion Criteria:

Diabetes mellitus.
Alcohol, tobacco, or drug abuse.
Significant liver, kidney, thyroid, or other endocrine diseases.
Frequent consumption of nuts or known history of allergy to them.
Use of plant sterol, oral antidiabetic drugs, supplemental use of phyllium, fish oil supplements and multivitamins, vitamin E or other antioxidant supplements.
Bad dentures, implying difficulty to chew pistachios.
Being pregnant or wishing to become a pregnant 6 months before or during the study, lactating 6wk before or during the study.
Following vegetarian or weight loss diets.
Other medical or social conditions that difficult the compliance to the intervention.
No Results Posted