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

NCT ID: NCT03680027

Last Updated: 2018-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-10
• Study Completion Date: 2015-09-30

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.

Conditions

Hyperlipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Walnut-enriched Group

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Walnut-enriched Group

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Mediterranean University

OTHER

Sponsor Role: lead

Responsible Party

Gözde Okburan

Senior Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gözde Okburan

Role: PRINCIPAL_INVESTIGATOR

Eastern Mediterranean University

Other Identifiers

2015/13-04

Identifier Type: -

Identifier Source: org_study_id