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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-18

Study Completion Date

2020-05-18

Brief Summary

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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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Detailed Description

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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 \[CRP\]).

Conditions

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Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Low calorie diets with nuts

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

Group Type ACTIVE_COMPARATOR

Nut consumption

Intervention Type DIETARY_SUPPLEMENT

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

Low calorie diet

Intervention Type OTHER

Low calorie diet

Group Type PLACEBO_COMPARATOR

Low calorie diet

Intervention Type OTHER

Low calorie diet

Interventions

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Nut consumption

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

Intervention Type DIETARY_SUPPLEMENT

Low calorie diet

Intervention Type OTHER

Other Intervention Names

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Dietary Modification

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No