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
1 other identifier
interventional
67
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2019
CompletedFirst Posted
Study publicly available on registry
September 6, 2019
CompletedStudy Start
First participant enrolled
September 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2020
CompletedMay 19, 2020
May 1, 2020
8 months
August 31, 2019
May 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
C reactive protein (CRP)
C reactive protein
8 week
Secondary Outcomes (1)
inflammatory cytokines
8 week
Study Arms (2)
Low calorie diets with nuts
ACTIVE COMPARATORLow calorie diet in which 20 percent of daily calories will be provided from nuts
Low calorie diet
PLACEBO COMPARATORLow calorie diet
Interventions
daily consumption of 20 percent of daily calories intake from nuts (pistachio, almond and peanuts)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- َ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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
Tehran, 19395-4741, Iran
Related Publications (1)
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.
PMID: 34794330DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Academic Member
Study Record Dates
First Submitted
August 31, 2019
First Posted
September 6, 2019
Study Start
September 18, 2019
Primary Completion
May 18, 2020
Study Completion
May 18, 2020
Last Updated
May 19, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share