Effect of Goji Berry Consumption on Biochemical Parameters

January 2, 2024 updated by: Eastern Mediterranean University

The Evaluation of the Impact of Goji Berry Consumption Some Biochemical Parameters in Healthy Individuals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthy individuals have been divided into control and study groups. Individuals in both group have same characteristics such as age, gender, and body mass index (Control Group: 35 individuals - Study Group: 35 individuals). Both group were asked to maintain their normal diets. In addition, the study group consume 20 g of dried goji berry per day and did not consume any fruit with a similar antioxidant content during the 8 weeks study period. The control group was asked to exclude goji berry and similar fruits with high antioxidant content from their diet during the 8 weeks study period. The 20 g goji berry for per day was given weekly to each individual in a study group in transparent bags. At the beginning of the study and every 15 days, food consumption record for 3 consecutive days (2 weekdays and 1 weekend), a 3-day physical activity record, and anthropometric measurements (weight, height, waist and hip circumferences, body composition analysis) were taken. Blood parameters (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), very low density lipoprotein (VLDL), triglyceride, glucose, insulin, homeostatic model assessment of insulin resistance (HOMA-IR), HbA1c) of individuals were taken at the beginning and the end of the study.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
    • Turkish Republic Of Northern Cyprus
      • Famagusta, Turkish Republic Of Northern Cyprus, Cyprus
        • Eastern Mediterranean University

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

Not meeting the criteria for inclusion in the study

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
In control group participants had 8-weeks follow-up without any intervention.
Experimental: Interventional Group
In interventional group participants had 8-weeks follow-up with 20 g/day goji berry consumption intervention.
Dietary supplement: Goji Berry
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum lipids
Time Frame: 8 weeks
change in serum lipids level in interventional group.
8 weeks
fasting glucose
Time Frame: 8 weeks
change in fasting glucose levels in interventional group.
8 weeks
serum insulin
Time Frame: 8 weeks
change in serum insulin levels in interventional group.
8 weeks

Collaborators and Investigators

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

Sponsor

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)

May 15, 2022

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-22/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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