Cardiovascular Risk FactorNCT04583696
The Investigation of Effect on Blood Lipid Parameters With Walnut Addition of Diet
A study testing The Investigation of effect on Blood Lipid parameters with walnut addition of Diet in people with Cardiovascular Risk Factor, run by Ege University.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- The Investigation of effect on Blood Lipid parameters with walnut addition of Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2014to 24 Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Obesity
- Diabetes Mellitus
- Acoholic and chronic diseases such as kidney
- Thyroid
- Hepatitis
- Cancer etc.
About this study
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.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- The Investigation of effect on Blood Lipid parameters with walnut addition of Diet
- Keywords
- cholesterol, walnut consumption, small dense LDL, blood lipids, dietary fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Investigation of effect on Blood Lipid parameters with walnut addition of DietDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Walnut Consumption of Healthy Volunteers | Experimental | Not described Receives: Dietary Supplement: The Investigation of effect on Blood Lipid parameters with walnut addition of Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: The first day of the research and the end day (3 weeks later) were analyzed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start12 Dec 2014
- Primary completion10 Mar 2015
- Study completion24 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Sifa University
- Responsible party
- Principal investigator, Fatih Cesur, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583696
- Sponsor's protocol ID
- 227-63
- Status last verified
- Oct 2020
- First submitted
- 22 Sep 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12080402Jenkins 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.
PubMed 29789878Ai 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.
PubMed 20431054Mohammadi-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.
PubMed 30390893Bamberger 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.
PubMed 28984822
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Effect on Blood Lipid Parameters With Walnut Addition of Diet
- ClinicalTrials.gov ID
- NCT04583696
- Acronym / sponsor ID
- 227-63
- Conditions
- Cardiovascular Risk Factor
- Keywords
- cholesterol, walnut consumption, small dense LDL, blood lipids, dietary fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Sifa University
- Study start
- 12 Dec 2014 (actual)
- Primary completion
- 10 Mar 2015 (actual)
- Study completion
- 24 Apr 2015 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Walnut Consumption of Healthy Volunteers | Experimental | Dietary Supplement: The Investigation of effect on Blood Lipid parameters with walnut addition of Diet |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Obesity
- Diabetes Mellitus
- Acoholic and chronic diseases such as kidney
- Thyroid
- Hepatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Investigation of effect on Blood Lipid parameters with walnut addition of DietParticipants 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. | Dietary supplement | Walnut Consumption of Healthy Volunteers |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 12080402Iwamoto 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.
- Results publication: PubMed 29789878Jenkins 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.
- Results publication: PubMed 20431054Ai 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.
- Results publication: PubMed 30390893Mohammadi-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.
- Results publication: PubMed 28984822Bamberger 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.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Risk Factor
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Heart Failure, Cardiovascular Risk Factors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The Investigation of effect on Blood Lipid parameters with walnut addition of Diet in people with Cardiovascular Risk Factor, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04583696, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.