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

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04078919
• Other study ID #: 890
• Status: Completed
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: May 18, 2020

Study information

• Verified date: May 2020
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 18, 2020
• Est. primary completion date: May 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Inflammation

Intervention

Dietary Supplement:
• Nut consumption
daily consumption of 20 percent of daily calories intake from nuts (pistachio, almond and peanuts)

Other:
• Low calorie diet
Low calorie diet

Locations

Country	Name	City	State
Iran, Islamic Republic of	Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Shahid Beheshti University	Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C reactive protein (CRP)	C reactive protein	8 week
Secondary	inflammatory cytokines	Change in plasma level of inflammatory cytokines	8 week