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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04078919

Enrollment

Registered

2019-09-06

Start date

2019-09-18

Completion date

2020-05-18

Last updated

2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor

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 \[CRP\]).

Interventions

DIETARY_SUPPLEMENTNut consumption

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

OTHERLow calorie diet

Low calorie diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
C reactive protein (CRP)	8 week	C reactive protein

Secondary

Measure	Time frame	Description
inflammatory cytokines	8 week	Change in plasma level of inflammatory cytokines

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026