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Completed

NCT Number: NCT04078919

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

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.

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Key information

Conditions

Cardiovascular Risk Factor

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute

Tehran, 19395-4741, Iran

About this study

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]).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nut consumption

Dietary Supplement

daily consumption of 20 percent of daily calories intake from nuts (pistachio, almond and peanuts)

Other names: Dietary Modification

low calorie diet

Other

Low calorie diet

Primary outcomes

  1. C reactive protein (CRP)

    Time frame: 8 week

    C reactive protein

Secondary outcomes

  1. inflammatory cytokines

    Time frame: 8 week

    Change in plasma level of inflammatory cytokines

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Collaborators

  • Shahid Beheshti University of Medical Sciences

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 6, 2019
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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