Trials / Completed
CompletedNCT04078919
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Shahid Beheshti University · Academic / Other
- Sex
- All
- Age
- 35 Years – 70 Years
- Healthy volunteers
- Not accepted
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 \[CRP\]).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2019-09-18
- Primary completion
- 2020-05-18
- Completion
- 2020-05-18
- First posted
- 2019-09-06
- Last updated
- 2020-05-19
Locations
1 site across 1 country: Iran
Source: ClinicalTrials.gov record NCT04078919. Inclusion in this directory is not an endorsement.