NCT03680027

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
Last Updated

September 24, 2018

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

September 19, 2018

Last Update Submit

September 21, 2018

Conditions

Hyperlipidemias

Keywords

Serum lipidsHyperlipidemiaWalnut

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control Group

NO INTERVENTION

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

Interventional Group

EXPERIMENTAL

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

Interventions

Walnut-enriched GroupDIETARY_SUPPLEMENT

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

Interventional Group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Gözde Okburan

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Instructor

Study Record Dates

First Submitted

September 19, 2018

First Posted

September 21, 2018

Study Start

July 10, 2015

Primary Completion

August 27, 2015

Study Completion

September 30, 2015

Last Updated

September 24, 2018

Record last verified: 2018-09