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

September 21, 2018 updated by: Gözde Okburan, Eastern Mediterranean University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
In 'Control group' participants had 6 week follow-up without any intervention.
Experimental: Interventional Group
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.
Dietary supplement: Walnut-enriched Group
All subjects supplemented with 40 g/day of walnuts for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in serum lipids and fasting glucose levels
Time Frame: Six weeks
In both group, participants have decreased serum total cholesterol and LDL-cholesterol.However especially walnut-enrcihed group significantly changed fasting glucose and insulin levels.
Six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Mediterranean University

Investigators

  • Principal Investigator: Gözde Okburan, Eastern Mediterranean University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2015

Primary Completion (Actual)

August 27, 2015

Study Completion (Actual)

September 30, 2015

Study Registration Dates

First Submitted

September 19, 2018

First Submitted That Met QC Criteria

September 19, 2018

First Posted (Actual)

September 21, 2018

Study Record Updates

Last Update Posted (Actual)

September 24, 2018

Last Update Submitted That Met QC Criteria

September 21, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/13-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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