Back to resultsEffect of a Low Calorie Diet Containing Nuts on Systemic and Vascular Inflammation
Primary Purpose
Cardiovascular Risk Factor
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Nut consumption
Low calorie diet
Sponsored by
About this trial
This is an interventional supportive care trial for Cardiovascular Risk Factor
Eligibility Criteria
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
Sites / Locations
- Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Low calorie diets with nuts
Low calorie diet
Arm Description
Low calorie diet in which 20 percent of daily calories will be provided from nuts
Low calorie diet
Outcomes
Primary Outcome Measures
C reactive protein (CRP)
C reactive protein
Secondary Outcome Measures
inflammatory cytokines
Change in plasma level of inflammatory cytokines
Full Information
NCT ID
NCT04078919
First Posted
August 31, 2019
Last Updated
May 17, 2020
Sponsor
Shahid Beheshti University
Collaborators
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04078919
Brief Title
Effect of a Low Calorie Diet Containing Nuts on Systemic and Vascular Inflammation
Official Title
Effect of Low Calorie Diets With and Without Nuts on Systemic and Vascular Inflammation in Patients With Stable Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
May 18, 2020 (Actual)
Study Completion Date
May 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University
Collaborators
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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]).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low calorie diets with nuts
Arm Type
Active Comparator
Arm Description
Low calorie diet in which 20 percent of daily calories will be provided from nuts
Arm Title
Low calorie diet
Arm Type
Placebo Comparator
Arm Description
Low calorie diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Nut consumption
Other Intervention Name(s)
Dietary Modification
Intervention Description
daily consumption of 20 percent of daily calories intake from nuts (pistachio, almond and peanuts)
Intervention Type
Other
Intervention Name(s)
Low calorie diet
Intervention Description
Low calorie diet
Primary Outcome Measure Information:
Title
C reactive protein (CRP)
Description
C reactive protein
Time Frame
8 week
Secondary Outcome Measure Information:
Title
inflammatory cytokines
Description
Change in plasma level of inflammatory cytokines
Time Frame
8 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
City
Tehran
ZIP/Postal Code
19395-4741
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34794330
Citation
Ghanavati M, Nasrollahzadeh J. A calorie-restricted diet enriched with tree nuts and peanuts reduces the expression of CX3CR1 in peripheral blood mononuclear cells in patients with coronary artery disease. Int J Vitam Nutr Res. 2023 Aug;93(4):329-338. doi: 10.1024/0300-9831/a000738. Epub 2021 Nov 19.
Results Reference
derived
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Effect of a Low Calorie Diet Containing Nuts on Systemic and Vascular Inflammation
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