NCT06190587

Brief Summary

Goji Berry as a functional food have been shown to reduce risk of hyperlipidemia, type 2 diabetes, etc. However, human studies are limited in this area. In this study, it has been aimed to evaluate the effect of goji berry consumption on some biochemical parameters in healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started May 2022

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

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

May 15, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

November 1, 2023

Last Update Submit

January 2, 2024

Conditions

HealthyHyperlipidemias

Keywords

Functional FoodGoji BerrySerum LipidsSerum Fasting Glucose

Outcome Measures

Primary Outcomes (3)

  • serum lipids

    change in serum lipids level in interventional group.

    8 weeks

  • fasting glucose

    change in fasting glucose levels in interventional group.

    8 weeks

  • serum insulin

    change in serum insulin levels in interventional group.

    8 weeks

Study Arms (2)

Control Group

NO INTERVENTION

In control group participants had 8-weeks follow-up without any intervention.

Interventional Group

EXPERIMENTAL

In interventional group participants had 8-weeks follow-up with 20 g/day goji berry consumption intervention.

Dietary Supplement: Goji Berry

Interventions

Goji BerryDIETARY_SUPPLEMENT

As a functional food goji berry contains 19 amino acids, 21 minerals, a wide range of carotenoids (β-Carotene, Neoxanthin, Cryptoxanthin, Zeaxanthin), polysaccharides, flavonoids, phytosterols, vitamin A, C and E.

Interventional Group

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 20-25 kg/m²
  • Female individuals are not in the period of lactation and menopause,
  • Absence of any chronic or acute disease diagnosed by a physician,
  • No allergies to Goji Berry
  • Not consuming goji berry and similar fruits regularly for the last 1 month.
  • Not being in the process of body weight loss
  • Not doing strenuous physical activity
  • Not taking any medication or antioxidant vitamin support
  • Not smoking
  • Not consuming alcohol (moderate alcohol consumption)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, Turkish Republic of Northern Cyprus, Cyprus

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2023

First Posted

January 5, 2024

Study Start

May 15, 2022

Primary Completion

October 1, 2023

Study Completion

October 30, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

CY(1)