- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04583696
The Investigation of Effect on Blood Lipid Parameters With Walnut Addition of Diet
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Walnut Consumption of Healthy Volunteers
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within research completion, an average of 2 week
|
|
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
|
The first day of the research and the end day (3 weeks later) were analyzed.
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.2009.137489. Epub 2010 Apr 29.
- 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. doi: 10.1038/sj.ejcn.1601400.
- 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 reanalysis of a randomised controlled trial. Diabetologia. 2018 Aug;61(8):1734-1747. doi: 10.1007/s00125-018-4628-9. Epub 2018 May 23. Erratum In: Diabetologia. 2019 Mar;62(3):549-552.
- 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. 2018 Dec;28:52-58. doi: 10.1016/j.clnesp.2018.07.009. Epub 2018 Sep 1.
- 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 Prospective, Randomized, Controlled Trial. Nutrients. 2017 Oct 6;9(10):1097. doi: 10.3390/nu9101097.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 227-63
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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