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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04583696
Other study ID # 227-63
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 12, 2014
Est. completion date April 24, 2015

Study information

Verified date October 2020
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 24, 2015
Est. primary completion date March 10, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Ege University Sifa University

References & Publications (5)

Ai M, Otokozawa S, Asztalos BF, Ito Y, Nakajima K, White CC, Cupples LA, Wilson PW, Schaefer EJ. Small dense LDL cholesterol and coronary heart disease: results from the Framingham Offspring Study. Clin Chem. 2010 Jun;56(6):967-76. doi: 10.1373/clinchem.2 — View Citation

Bamberger C, Rossmeier A, Lechner K, Wu L, Waldmann E, Stark RG, Altenhofer J, Henze K, Parhofer KG. A Walnut-Enriched Diet Reduces Lipids in Healthy Caucasian Subjects, Independent of Recommended Macronutrient Replacement and Time Point of Consumption: a — View Citation

Iwamoto M, Imaizumi K, Sato M, Hirooka Y, Sakai K, Takeshita A, Kono M. Serum lipid profiles in Japanese women and men during consumption of walnuts. Eur J Clin Nutr. 2002 Jul;56(7):629-37. — View Citation

Jenkins DJA, Kendall CWC, Lamarche B, Banach MS, Srichaikul K, Vidgen E, Mitchell S, Parker T, Nishi S, Bashyam B, de Souza RJ, Ireland C, Pichika SC, Beyene J, Sievenpiper JL, Josse RG. Nuts as a replacement for carbohydrates in the diabetic diet: a rean — View Citation

Mohammadi-Sartang M, Bellissimo N, Totosy de Zepetnek JO, Bazyar H, Mahmoodi M, Mazloom Z. Effects of walnuts consumption on vascular endothelial function in humans: A systematic review and meta-analysis of randomized controlled trials. Clin Nutr ESPEN. 2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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. Within research completion, an average of 2 week
Primary 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. 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 The first day of the research and the end day (3 weeks later) were analyzed.
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