NCT04583696

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2015

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

September 22, 2020

Last Update Submit

October 9, 2020

Conditions

Keywords

cholesterolwalnut consumptionsmall dense LDLblood lipidsdietary fiber

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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.

Study Arms (1)

Walnut Consumption of Healthy Volunteers

EXPERIMENTAL
Dietary Supplement: The Investigation of effect on Blood Lipid parameters with walnut addition of Diet

Interventions

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.

Walnut Consumption of Healthy Volunteers

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Obesity
  • Diabetes Mellitus
  • Acoholic and chronic diseases such as kidney
  • Thyroid
  • Hepatitis
  • Cancer etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 12080402BACKGROUND
  • 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.

  • 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.

  • 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 Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2020

First Posted

October 12, 2020

Study Start

December 12, 2014

Primary Completion

March 10, 2015

Study Completion

April 24, 2015

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share