Clinical trial NCT06190587: Effect of Goji Berry Consumption on Biochemical Parameters
Official title: The Evaluation of the Impact of Goji Berry Consumption Some Biochemical Parameters in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Hyperlipidemias
Keywords: Functional Food
Goji Berry
Serum Lipids
Serum Fasting Glucose
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: serum lipids
timeFrame: 8 weeks
measure: fasting glucose
timeFrame: 8 weeks
measure: serum insulin
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
state: Turkish Republic Of Northern Cyprus
Study officials:
References: