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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03680027
Other study ID # 2015/13-04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 10, 2015
Est. completion date September 30, 2015

Study information

Verified date September 2018
Source Eastern Mediterranean University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date September 30, 2015
Est. primary completion date August 27, 2015
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Walnut-enriched Group
All subjects supplemented with 40 g/day of walnuts for 6 weeks.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eastern Mediterranean University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Six weeks
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