Effect of Goji Berry Consumption on Biochemical Parameters

NCT ID: NCT06190587

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2023-10-30

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.

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.

Conditions

Healthy; Hyperlipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventional Group

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

Group Type: EXPERIMENTAL

Goji Berry

Intervention Type: DIETARY_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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eastern Mediterranean University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eastern Mediterranean University

Famagusta, Turkish Republic of Northern Cyprus, Cyprus

Countries

Cyprus

Other Identifiers

2022-22/01

Identifier Type: -

Identifier Source: org_study_id