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Effects Of Walnut-Enriched Diet On Blood Lipids And Glucose Profiles In Hyperlipidemic Subjects

Primary Purpose

Hyperlipidemias

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Walnut-enriched Group

About this trial

This is an interventional treatment trial for Hyperlipidemias focused on measuring Serum lipids, Hyperlipidemia, Walnut

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Hyperlipidemic patients who are not using any lipid lowering medications
Non-smoker
No alcohol consumption
Individuals who are having ≤30kg/m2
Individuals who do not have any allergy for nut consumption
Female participants who are not pregnant or breastfeeding
Individuals should not be in a weight loss programme
Having not consumed regular nuts for the last 1 month,
Except hypertension, they should not have other chronic diseases (such as diabetes, chronic renal failure)
No intense exercise

Exclusion Criteria:

Failure to meet the criteria for inclusion criteria.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Interventional Group

Arm Description

In 'Control group' participants had 6 week follow-up without any intervention.

In 'Interventional group' participants had 6 week follow-up and during that period of time, they were asked to consume 40g/day walnut. Participants in intervention group was ensured to consume all 40g of walnut every day, during their snack times for 6 weeks.

Outcomes

Primary Outcome Measures

Reduction in serum lipids and fasting glucose levels

In both group, participants have decreased serum total cholesterol and LDL-cholesterol.However especially walnut-enrcihed group significantly changed fasting glucose and insulin levels.

Secondary Outcome Measures

Full Information

NCT ID

NCT03680027

First Posted

September 19, 2018

Last Updated

September 21, 2018

Sponsor

Eastern Mediterranean University

1. Study Identification

Unique Protocol Identification Number

NCT03680027

Brief Title

Effects Of Walnut-Enriched Diet On Blood Lipids And Glucose Profiles In Hyperlipidemic Subjects

Official Title

Effects Of Walnut-Enriched Diet On Blood Lipids And Glucose Profiles In Hyperlipidemic Subjects: A Randomized-Controlled Trial: A Randomized-Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

July 10, 2015 (Actual)

Primary Completion Date

August 27, 2015 (Actual)

Study Completion Date

September 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Eastern Mediterranean University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Walnuts have been shown to reduce serum lipids in hyperlipidemic individuals with a well-controlled feeding trials. Current study have been determined the effects of daily walnut consumption on serum lipids, fasting glucose and insulin levels in hyperlipidemic individuals.

Detailed Description

In this, randomized controlled trial, mild to moderate hyperlipidemic subjects were randomly divided into 2 groups as walnut-enriched (n=20) and control (n=17) groups for 6 weeks. All subjects adhered to a medical nutrition therapy as low-fat and low-cholesterol diet. The walnut-enriched group was supplemented with 40 g/day of walnuts added to their diets. In order to follow nutritional status of subjects, they were visited every 15 days (in total 4 times). Anthropometric measurements of the subjects were taken and were monitored at each visit during the study. Blood samples were measured at the beginning and again at the end of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemias

Keywords

Serum lipids, Hyperlipidemia, Walnut

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

In 'Control group' participants had 6 week follow-up without any intervention.

Arm Title

Interventional Group

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Walnut-enriched Group

Intervention Description

All subjects supplemented with 40 g/day of walnuts for 6 weeks.

Primary Outcome Measure Information:

Title

Reduction in serum lipids and fasting glucose levels

Description

In both group, participants have decreased serum total cholesterol and LDL-cholesterol.However especially walnut-enrcihed group significantly changed fasting glucose and insulin levels.

Time Frame

Six weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hyperlipidemic patients who are not using any lipid lowering medications Non-smoker No alcohol consumption Individuals who are having ≤30kg/m2 Individuals who do not have any allergy for nut consumption Female participants who are not pregnant or breastfeeding Individuals should not be in a weight loss programme Having not consumed regular nuts for the last 1 month, Except hypertension, they should not have other chronic diseases (such as diabetes, chronic renal failure) No intense exercise Exclusion Criteria: Failure to meet the criteria for inclusion criteria.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gözde Okburan

Organizational Affiliation

Eastern Mediterranean University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Effects Of Walnut-Enriched Diet On Blood Lipids And Glucose Profiles In Hyperlipidemic Subjects

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