Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Investigation of Effect on Blood Lipid Parameters With Walnut Addition of Diet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04583696
Recruitment Status : Completed
First Posted : October 12, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Sifa University
Information provided by (Responsible Party):
Fatih Cesur, Ege University

Brief Summary:

Introduction There is a strong relationship between eating habits and diseases of the cardiovascular system. It is known that walnut consumption has positive effects on cardiovascular system diseases. However, its effect on small dense LDL (sdLDL) is discussed. Therefore in this study, you participated the effects of walnut consumption on the serum lipids values, especially sdLDL values of healthy volunteers.

Methods Volunteers participating in this study were offered 30 grams of walnuts per day for 21 days. Walnuts were consumed on empty stomach or with breakfast every morning for 21 days. The blood values of subjects were measured at the beginning and the end of the study. The serum was obtained from the taken blood and blood lipid/hemoglobin parameters were measured on routine blood work. Food consumption records and surveys were taken from individuals.


Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Dietary Supplement: The Investigation of effect on Blood Lipid parameters with walnut addition of Diet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Investigation of Effect on Blood Lipid Parameters With Walnut Addition of Diet
Actual Study Start Date : December 12, 2014
Actual Primary Completion Date : March 10, 2015
Actual Study Completion Date : April 24, 2015

Arm Intervention/treatment
Experimental: Walnut Consumption of Healthy Volunteers Dietary Supplement: The Investigation of effect on Blood Lipid parameters with walnut addition of Diet
Participants were asked to consume 30 g of walnuts daily for 21 days. Individuals have consumed walnuts on an empty stomach in the morning or with breakfast.




Primary Outcome Measures :
  1. Blood from the participants was collected before and at the end of the study. Later in this study, sdLDL levels of blood taken from participants were measured by the Elisa method. [ Time Frame: Within research completion, an average of 2 week ]
    It can be said that walnut consumption reduces the risk of CAD. In 30% of patients taking cholesterol-lowering drugs, cholesterol parameters may drop to the desired levels and severe vascular lesions still may occur. Also, individuals with normal LDL values may have cardiovascular diseases. Findings are suggesting that in these individuals, the prevalence of CAD is higher due to sdLDL positivity. sdLDL passes through the endothelial barrier easier and is exposed to oxidation more than LDL, which is larger and lower in density. Therefore is atherogenic.

  2. Blood from the participants was collected before and at the end of the study. Later, the serum lipids of the blood taken from the participants consuming walnuts were measured in the hospital. [ Time Frame: The first day of the research and the end day (3 weeks later) were analyzed. ]
    It can be said that walnut consumption reduces the risk of CAD. The fact that walnuts contain fatty acids can be shown as a reason for their beneficial effect on blood lipid levels. We can attribute this to the fact that walnuts contain high levels of unsaturated and low levels of saturated fatty acids. In various studies, the walnut-enriched diet has been reported to reduce TC, LDL, and TG



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Do not consume any products such as nuts and walnuts (the frequency of consumption should not be more than once a week)
  • Have no allergies to foods such as nuts and walnuts
  • Do not take drugs on a daily and continuous basis

Exclusion Criteria:

  • Obesity
  • Diabetes Mellitus
  • Acoholic and chronic diseases such as kidney
  • Thyroid
  • Hepatitis
  • Cancer etc.
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Fatih Cesur, Principal Investigator, Ege University
ClinicalTrials.gov Identifier: NCT04583696    
Other Study ID Numbers: 227-63
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fatih Cesur, Ege University:
cholesterol
walnut consumption
small dense LDL
blood lipids
dietary fiber