Effect of a Low Calorie Diet Containing Nuts on Systemic and Vascular Inflammation

Study Overview
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Brief Summary
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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
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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]).

Official Title
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Effect of Low Calorie Diets With and Without Nuts on Systemic and Vascular Inflammation in Patients With Stable Coronary Artery Disease

Conditions
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Cardiovascular Risk Factor

Intervention / Treatment
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* Dietary Supplement: Nut consumption
* Other: Low calorie diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: َ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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low calorie diets with nuts<br>Low calorie diet in which 20 percent of daily calories will be provided from nuts | Dietary Supplement: Nut consumption<br>* daily consumption of 20 percent of daily calories intake from nuts (pistachio, almond and peanuts)<br>* Other names: Dietary Modification;Other: Low calorie diet<br>* Low calorie diet<br>|
| Placebo Comparator: Low calorie diet<br>Low calorie diet | Other: Low calorie diet<br>* Low calorie diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C reactive protein (CRP) | C reactive protein | 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory cytokines | Change in plasma level of inflammatory cytokines | 8 week |