Effect of Goji Berry Consumption on Biochemical Parameters

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06190587
• Other study ID #: 2022-22/01
• Status: Completed
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: January 2024
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 30, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Hyperlipidemias

Intervention

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

Locations

Country	Name	City	State
Cyprus	Eastern Mediterranean University	Famagusta	Turkish Republic Of Northern Cyprus

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum lipids	change in serum lipids level in interventional group.	8 weeks
Primary	fasting glucose	change in fasting glucose levels in interventional group.	8 weeks
Primary	serum insulin	change in serum insulin levels in interventional group.	8 weeks