Type 2 Diabetes MellitusEPIRDEMNCT01441921
Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus
A study testing Pistachios in people with Type 2 Diabetes Mellitus, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Pistachios
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Human Nutrition Unit, Faculty of Medicine, Rovira i Virgili University
Reus, Tarragona, 43201
About this study
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.
Read the detailed description
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
- Type 2 Diabetes Mellitus
- Being tested
- Pistachios, control diet
- Keywords
- pistachio intake, insulin resistance, type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control diet | Active comparator | Low-fat normocaloric diet (30% fat, 55% carbohydrates, 15% proteins) Receives: Other: control diet |
| Pistachio diet | Experimental | Diet supplemented with 2 ounces of pistachio (35% fat, 50% carbohydrates adn 15% protein) Receives: Dietary Supplement: Pistachios |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Cpeptide, resistin, IL-6, IL-18, Ghrelin, leptin, adiponectin, GLP-1 and oxidized LDL will be measured.
Measured: 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
Tissue factor, fibrinogen, PAI-1, vWF will be measured.
Measured: 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
Plasmi lipoprotein size will be measured by polycacrylamide gradient gel electrophoresis
Measured: 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
Advanced glycation end products and soluble receptor of advanced glycation-end produtcs will be measured
Measured: 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
RNA from peripheral leukocytes will be isolated for the subsequent measurements of changes in gene expression of toll-like receptors, GLUT-4, C-peptide, resistin adn IL-6, and genes involved in telomere maintenance and oxidation
Measured: 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 cellular glucose uptake according to the intervention arm
Glucose uptake and GLUT4 protein levels will be assessed in peripheral leukocytes
Measured: 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 platelet function according to the intervention arm
Platelet number, mean platelet volume and platelet factor 4 in blood, and urinary levels of 11-dehydro-thromboxane B2 will be assessed.
Measured: 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 telomeric length of leukocytes (LTL)
Telomere lenght will be evaluated as a biomarker of biological age and general health status. Telomere attrition may play an important role in the pathogenesis and severity of type 2 diabetes (T2D) increasing the probability of beta-cell senescence, leading to reduced cell mass and decreased insulin secretion.
Measured: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first intervention arm. Measurements will be not analysed after the second period due to expected carry-over effect.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Western Pistachio Association
- Responsible party
- Principal investigator, Dra Monica Bullo, Institut Investigacio Sanitaria Pere Virgili
- Investigators
- Monica Bullo, Dra., Principal investigator, Institut Investigacio Sanitaria Pere Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441921
- Sponsor's protocol ID
- PV11059S
- Acronym
- EPIRDEM
- Status last verified
- Feb 2019
- First submitted
- 20 Sep 2011
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25791863Hernandez-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.
PubMed 25125505Hernandez-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.
PubMed 28432876Hernandez-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.
PubMed 27383196Canudas 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.
PubMed 31051499
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01441921
- Acronym / sponsor ID
- EPIRDEM / PV11059S
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- pistachio intake, insulin resistance, type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Collaborators
- Western Pistachio Association
- Study start
- Sep 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control diet | Active comparator | Other: control dietLow-fat normocaloric diet (30% fat, 55% carbohydrates, 15% proteins) |
| Pistachio diet | Experimental | Dietary Supplement: PistachiosDiet supplemented with 2 ounces of pistachio (35% fat, 50% carbohydrates adn 15% protein) |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PistachiosParticipants 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. | Dietary supplement | Pistachio diet |
| control dietParticipants 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 |
Primary outcome
Changes from baseline in circulating levels of glucose and insulin according to the intervention arm
Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
Measurement of circulating glucose and insulin levels and cellular glucose uptake
8 secondary outcomes
Changes from baseline in inflammatory, oxidative and metabolic risk markers related to glucose/insulin metabolism according to the intervention arm
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 cellular glucose uptake according to the intervention arm
Time frame: 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 platelet function according to the intervention arm
Time frame: 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 telomeric length of leukocytes (LTL)
Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first intervention arm. Measurements will be not analysed after the second period due to expected carry-over effect.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Background: PubMed 25791863Hernandez-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.
- Results publication: PubMed 25125505Hernandez-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.
- Results publication: PubMed 28432876Hernandez-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.
- Results publication: PubMed 27383196Hernandez-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.
- Derived from this study: PubMed 31051499Canudas 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Bullo, Dra. principal investigator
Institut Investigacio Sanitaria Pere Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pistachios in people with Type 2 Diabetes Mellitus, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in circulating levels of glucose and insulin according to the intervention arm (time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01441921, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019.