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

Shahid Beheshti University

Status: Completed

Conditions: Cardiovascular Risk Factor

Treatments: Dietary Supplement: Nut consumption; Other: Low calorie diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04078919

890

Details and patient eligibility

About

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.

Full 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]).

Enrollment: 67 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups, including a placebo group

Low calorie diets with nuts

Active Comparator group

Description:

Low calorie diet in which 20 percent of daily calories will be provided from nuts

Treatment:

Other: Low calorie diet

Dietary Supplement: Nut consumption

Low calorie diet

Placebo Comparator group

Description:

Low calorie diet

Treatment:

Other: Low calorie diet