HealthyNCT06190587
Effect of Goji Berry Consumption on Biochemical Parameters
A study testing Goji Berry in people with Healthy and Hyperlipidemias, run by Eastern Mediterranean University at 1 site in Cyprus.
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. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hyperlipidemias
- What is being tested?
- Goji Berry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCyprus
- Study dates
- 15 May 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- Not doing strenuous physical activity
- Not taking any medication or antioxidant vitamin support
- Not smoking
- Not consuming alcohol (moderate alcohol consumption)
Who cannot join
- Not meeting the criteria for inclusion in the study
Trial locations and contacts
1 site in 1 country.
Cyprus1 site
Eastern Mediterranean University
Famagusta, Turkish Republic of Northern Cyprus
About this study
Official title: 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.
Read the 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
- Being tested
- Goji Berry
- Keywords
- Functional Food, Goji Berry, Serum Lipids, Serum Fasting Glucose
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Goji Berry |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum lipids
change in serum lipids level in interventional group.
Measured: 8 weeks
fasting glucose
change in fasting glucose levels in interventional group.
Measured: 8 weeks
serum insulin
change in serum insulin levels in interventional group.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start15 May 2022
- Primary completion1 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190587
- Sponsor's protocol ID
- 2022-22/01
- Status last verified
- Jan 2024
- First submitted
- 1 Nov 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Impact of Goji Berry Consumption Some Biochemical Parameters in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06190587
- Acronym / sponsor ID
- 2022-22/01
- Conditions
- Healthy, Hyperlipidemias
- Keywords
- Functional Food, Goji Berry, Serum Lipids, Serum Fasting Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –In control group participants had 8-weeks follow-up without any intervention. |
| Interventional Group | Experimental | Dietary Supplement: Goji BerryIn interventional group participants had 8-weeks follow-up with 20 g/day goji berry consumption intervention. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (1 listed)
- Not meeting the criteria for inclusion in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goji BerryAs 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. | Dietary supplement | Interventional Group |
Primary outcome
serum lipids
Time frame: 8 weeks
change in serum lipids level in interventional group.
fasting glucose
Time frame: 8 weeks
change in fasting glucose levels in interventional group.
serum insulin
Time frame: 8 weeks
change in serum insulin levels in interventional group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goji Berry in people with Healthy and Hyperlipidemias, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum lipids (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.