Cardiovascular Risk FactorNCT04078919
Effect of a Low Calorie Diet Containing Nuts on Systemic and Vascular Inflammation
A study testing Nut consumption and Low calorie diet in people with Cardiovascular Risk Factor, run by Shahid Beheshti University at 1 site in Iran.
Trial summary
Accumulating evidence from prospective observational studies and a large clinical trial suggests that nut intake lowers the risk of cardiovascular disease (CVD). Tree nuts are rich in unsaturated fats, soluble fiber, antioxidants, and phytosterols. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Nut consumption and Low calorie diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteIran
- Study dates
- 18 Sep 2019to 18 May 2020
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus)
- patients with coronary artery disease
- willing to participation in the study
Who cannot join
- َChronic kidney disease stage 3-5
- Any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation
Trial locations and contacts
1 site in 1 country.
Iran1 site
Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
Tehran, 19395-4741
About this study
Official title: Effect of Low Calorie Diets With and Without Nuts on Systemic and Vascular Inflammation in Patients With Stable Coronary Artery Disease
Accumulating evidence from prospective observational studies and a large clinical trial suggests that nut intake lowers the risk of cardiovascular disease (CVD). Tree nuts are rich in unsaturated fats, soluble fiber, antioxidants, and phytosterols. The purpose of this study is to compare the effects of low calorie diets with a mixture of nuts in comparison with low calorie diets in improving inflammatory markers in patients with stable coronary artery disease.
Read the detailed description
A randomized placebo controlled clinical trial will be conducted in modares hospital in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 66 eligible patients, aged 35-70 years. Intervention group will be received low calories diets as well as 20 percent of daily calories from mixed nuts (peanuts, pistachio and almond) and control group will be received low calories diets for 8 weeks. Fasting blood sample will be taken to measure inflammatory markers (Interleukine-6 [IL-6] and Interleukine-10 [IL-10] and C-Reactive Protein [CRP]).
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Nut consumption, Low calorie diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nut consumptionDietary supplement
Also called Dietary Modification
daily consumption of 20 percent of daily calories intake from nuts (pistachio, almond and peanuts)
Low calorie dietOther
Low calorie diet
| Study group | Role | What they receive |
|---|---|---|
| Low calorie diets with nuts | Active comparator | Low calorie diet in which 20 percent of daily calories will be provided from nuts Receives: Dietary Supplement: Nut consumption; Other: Low calorie diet |
| Low calorie diet | Placebo comparator | Low calorie diet Receives: Other: Low calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
C reactive protein (CRP)
C reactive protein
Measured: 8 week
Secondary outcomes (1)
inflammatory cytokines
Change in plasma level of inflammatory cytokines
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start18 Sep 2019
- Primary completion18 May 2020
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Principal investigator, Javad Nasrollahzadeh, Shahid Beheshti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078919
- Sponsor's protocol ID
- 890
- Status last verified
- May 2020
- First submitted
- 31 Aug 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghanavati M, Nasrollahzadeh J. A calorie-restricted diet enriched with tree nuts and peanuts reduces the expression of CX3CR1 in peripheral blood mononuclear cells in patients with coronary artery disease. Int J Vitam Nutr Res. 2023 Aug;93(4):329-338. doi: 10.1024/0300-9831/a000738. Epub 2021 Nov 19.
PubMed 34794330
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Calorie Diets With and Without Nuts on Systemic and Vascular Inflammation in Patients With Stable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04078919
- Acronym / sponsor ID
- 890
- Conditions
- Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 6 Sep 2019 (actual)
- 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.
Accumulating evidence from prospective observational studies and a large clinical trial suggests that nut intake lowers the risk of cardiovascular disease (CVD). Tree nuts are rich in unsaturated fats, soluble fiber, antioxidants, and phytosterols. The purpose of this study is to compare the effects of low calorie diets with a mixture of nuts in comparison with low calorie diets in improving inflammatory markers in patients with stable coronary artery disease.
Detailed description
A randomized placebo controlled clinical trial will be conducted in modares hospital in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 66 eligible patients, aged 35-70 years. Intervention group will be received low calories diets as well as 20 percent of daily calories from mixed nuts (peanuts, pistachio and almond) and control group will be received low calories diets for 8 weeks. Fasting blood sample will be taken to measure inflammatory markers (Interleukine-6 [IL-6] and Interleukine-10 [IL-10] and C-Reactive Protein [CRP]).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low calorie diets with nuts | Active comparator | Dietary Supplement: Nut consumption, Other: Low calorie dietLow calorie diet in which 20 percent of daily calories will be provided from nuts |
| Low calorie diet | Placebo comparator | Other: Low calorie dietLow calorie diet |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus)
- patients with coronary artery disease
- willing to participation in the study
Key exclusion criteria (2 listed)
- َChronic kidney disease stage 3-5
- Any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation
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 |
|---|---|---|
| Nut consumptionAlso: Dietary Modificationdaily consumption of 20 percent of daily calories intake from nuts (pistachio, almond and peanuts) | Dietary supplement | Low calorie diets with nuts |
| Low calorie dietLow calorie diet | Other | Low calorie diet, Low calorie diets with nuts |
Primary outcome
C reactive protein (CRP)
Time frame: 8 week
C reactive protein
1 secondary outcome
inflammatory cytokines
Time frame: 8 week
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 19 May 2020.
- Derived from this study: PubMed 34794330Ghanavati M, Nasrollahzadeh J. A calorie-restricted diet enriched with tree nuts and peanuts reduces the expression of CX3CR1 in peripheral blood mononuclear cells in patients with coronary artery disease. Int J Vitam Nutr Res. 2023 Aug;93(4):329-338. doi: 10.1024/0300-9831/a000738. Epub 2021 Nov 19.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Risk Factor
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Heart Failure, Cardiovascular Risk Factors
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nut consumption and Low calorie diet in people with Cardiovascular Risk Factor, run by Shahid Beheshti University at 1 site in Iran.
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 2 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 19 May 2020. 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 Iran. 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. Some participants in this study may receive a placebo. 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?
C reactive protein (CRP) (time frame: 8 week). 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 NCT04078919, which also lists 1 linked publication.
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 19 May 2020.