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

NCT ID: NCT01441921

Last Updated: 2019-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control diet

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

Group Type ACTIVE_COMPARATOR

control diet

Intervention Type OTHER

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.

Pistachio diet

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

Group Type EXPERIMENTAL

Pistachios

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Western Pistachio Association

OTHER

Sponsor Role collaborator

Institut Investigacio Sanitaria Pere Virgili

OTHER

Sponsor Role lead

Responsible Party

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Dra Monica Bullo

Principal Investigators

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Monica Bullo, Dra.

Role: PRINCIPAL_INVESTIGATOR

Institut Investigacio Sanitaria Pere Virgili

Locations

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Human Nutrition Unit, Faculty of Medicine, Rovira i Virgili University

Reus, Tarragona, Spain

Site Status

Countries

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Spain

References

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Hernandez-Alonso P, Salas-Salvado J, Baldrich-Mora M, Mallol R, Correig X, Bullo M. Effect of pistachio consumption on plasma lipoprotein subclasses in pre-diabetic subjects. Nutr Metab Cardiovasc Dis. 2015 Apr;25(4):396-402. doi: 10.1016/j.numecd.2015.01.013. Epub 2015 Feb 7.

Reference Type BACKGROUND
PMID: 25791863 (View on PubMed)

Hernandez-Alonso P, Salas-Salvado J, Baldrich-Mora M, Juanola-Falgarona M, Bullo M. Beneficial effect of pistachio consumption on glucose metabolism, insulin resistance, inflammation, and related metabolic risk markers: a randomized clinical trial. Diabetes Care. 2014 Nov;37(11):3098-105. doi: 10.2337/dc14-1431. Epub 2014 Aug 14.

Reference Type RESULT
PMID: 25125505 (View on PubMed)

Hernandez-Alonso P, Canueto D, Giardina S, Salas-Salvado J, Canellas N, Correig X, Bullo M. Effect of pistachio consumption on the modulation of urinary gut microbiota-related metabolites in prediabetic subjects. J Nutr Biochem. 2017 Jul;45:48-53. doi: 10.1016/j.jnutbio.2017.04.002. Epub 2017 Apr 12.

Reference Type RESULT
PMID: 28432876 (View on PubMed)

Hernandez-Alonso P, Giardina S, Salas-Salvado J, Arcelin P, Bullo M. Chronic pistachio intake modulates circulating microRNAs related to glucose metabolism and insulin resistance in prediabetic subjects. Eur J Nutr. 2017 Sep;56(6):2181-2191. doi: 10.1007/s00394-016-1262-5. Epub 2016 Jul 6.

Reference Type RESULT
PMID: 27383196 (View on PubMed)

Canudas S, Hernandez-Alonso P, Galie S, Muralidharan J, Morell-Azanza L, Zalba G, Garcia-Gavilan J, Marti A, Salas-Salvado J, Bullo M. Pistachio consumption modulates DNA oxidation and genes related to telomere maintenance: a crossover randomized clinical trial. Am J Clin Nutr. 2019 Jun 1;109(6):1738-1745. doi: 10.1093/ajcn/nqz048.

Reference Type DERIVED
PMID: 31051499 (View on PubMed)

Related Links

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Other Identifiers

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PV11059S

Identifier Type: -

Identifier Source: org_study_id

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