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

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor
• Interventions: Dietary Supplement: Nut consumption; Other: Low calorie diet

• Registration Number: NCT04078919
• Lead Sponsor: Shahid Beheshti University

Brief 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.

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 Timeline

• Study First Submitted: 2019-08-31
• Study First Submitted QC: 2019-08-31
• Study First Posted: 2019-09-06
• Study Start: 2019-09-18
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-17
• Primary Completion: 2020-05-18
• Study Completion: 2020-05-18
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low calorie diets with nuts	Low calorie diet	Low calorie diet in which 20 percent of daily calories will be provided from nuts
Low calorie diets with nuts	Nut consumption	Low calorie diet in which 20 percent of daily calories will be provided from nuts
Low calorie diet	Low calorie diet	Low calorie diet

Primary Outcome Measures

Name	Time	Method
C reactive protein (CRP)	8 week	C reactive protein

Secondary Outcome Measures

Name	Time	Method
inflammatory cytokines	8 week	Change in plasma level of inflammatory cytokines

Trial Locations

Locations (1)

Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute; 🇮🇷 Tehran, Iran, Islamic Republic of