NCT01441921

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

5 years

First QC Date

September 20, 2011

Last Update Submit

February 7, 2019

Conditions

Type 2 Diabetes Mellitus

Keywords

pistachio intakeinsulin resistancetype 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in circulating levels of glucose and insulin according to the intervention arm

    Measurement of circulating glucose and insulin levels and cellular glucose uptake

    Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

Secondary Outcomes (8)

  • Changes from baseline in inflammatory, oxidative and metabolic risk markers related to glucose/insulin metabolism according to the intervention arm

    Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

  • Changes from baseline in haemostatic parameters according to the intervention arm

    Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

  • Changes from baseline in HL and LDL size according to the intervention arm

    Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

  • Changes in advanced glycation end products according to the intervention arm

    Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

  • Changes from baseline in gene expression in the peripheral cells according to the intervention arm

    Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

  • +3 more secondary outcomes

Study Arms (2)

Control diet

ACTIVE COMPARATOR

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

Other: control diet

Pistachio diet

EXPERIMENTAL

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

Dietary Supplement: Pistachios

Interventions

PistachiosDIETARY_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.

Pistachio diet
control dietOTHER

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

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Reus, Tarragona, 43201, Spain

Location

Related Publications (5)

  • 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.

    PMID: 25791863BACKGROUND

  • 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.

    PMID: 25125505RESULT

  • 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.

    PMID: 28432876RESULT

  • 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.

    PMID: 27383196RESULT

  • 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.

    PMID: 31051499DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Monica Bullo, Dra.

    Institut Investigacio Sanitaria Pere Virgili

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigators

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 28, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

February 11, 2019

Record last verified: 2019-02

Locations

ES(1)