- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07268976
Jackfruit Effects on Adipokines and Cognition in Boxers
Effect of Jackfruit Consumption on Adipokine, Cerebral Response, Cognitive Performance and Anthropometric Parameters in Boxers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This interventional study evaluates the effects of different doses of jackfruit oil extract on healthy young boxers aged 18-25. Participants were randomly assigned to four groups and followed for 30 days.
Saliva samples were collected to measure irisin, omentin-1, and BDNF levels. Cognitive performance was assessed using the Wisconsin Card Sorting Test and the Trail Making Test. Anthropometric parameters including weight, BMI, waist, hip, chest, limb circumferences, and body composition were measured at baseline and on day 30.
Statistical analyses were performed using SPSS version 26. ANOVA, Duncan, and Pearson correlation tests were used to determine significant differences and relationships between variables.
This study is randomized and controlled. Participants receive either one of three doses of jackfruit oil extract or no supplement. The follow-up period is 30 days.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merkez
-
Bayburt, Merkez, Turkey (Türkiye), 69000
- Bayburt Gençlik Merkezi Kapali Spor Salonu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male boxers aged 18-25 years
- Healthy individuals without any diagnosed chronic disease
- Participating in regular weekly boxing training
- Able to continue training throughout the study period
- Willing to voluntarily participate in the study
- Able to provide written and/or verbal informed consent
Exclusion Criteria:
- Presence of chronic diseases (e.g., diabetes, cardiovascular disorders)
- Any injury or musculoskeletal condition preventing continuation of training
- Known allergy or hypersensitivity to jackfruit or its components
- Use of medications or supplements that could interfere with study outcomes
- Individuals who refuse to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: J0 - Kontrol Grubu
Katılımcılar hiçbir jackfruit yağı ekstresi almadı.
Sadece normal diyet ve antrenman programlarını sürdürdüler.
|
|
|
Experimental: J100
Katılımcılara 100 mg/kg jackfruit yağı ekstresi oral olarak 500 ml su içinde verildi.
Müdahale 30 gün boyunca günlük olarak uygulandı.
|
Participants in the experimental group will receive a daily dose of jackfruit supplement during the study period.
The supplement is administered orally and standardized for bioactive components.
Participants in the control group will not receive any jackfruit supplement.
|
|
Experimental: J200
Katılımcılara 200 mg/kg jackfruit yağı ekstresi oral olarak 500 ml su içinde verildi.
Müdahale 30 gün boyunca günlük olarak uygulandı.
|
Participants in the experimental group will receive a daily dose of jackfruit supplement during the study period.
The supplement is administered orally and standardized for bioactive components.
Participants in the control group will not receive any jackfruit supplement.
|
|
Experimental: J300
Katılımcılara 300 mg/kg jackfruit yağı ekstresi oral olarak 500 ml su içinde verildi.
Müdahale 30 gün boyunca günlük olarak uygulandı.
|
Participants in the experimental group will receive a daily dose of jackfruit supplement during the study period.
The supplement is administered orally and standardized for bioactive components.
Participants in the control group will not receive any jackfruit supplement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Salivary Irisin Level
Time Frame: Day 0 and Day 30
|
Irisin levels measured from saliva samples collected from participants using the ELISA method.
|
Day 0 and Day 30
|
|
Salivary Omentin-1 Level
Time Frame: Day 0 and Day 30.
|
Omentin-1 levels measured from saliva samples collected from participants using the ELISA method.
|
Day 0 and Day 30.
|
|
Salivary BDNF Level
Time Frame: Day 0 and Day 30.
|
BDNF levels measured from saliva samples collected from participants using the ELISA method.
|
Day 0 and Day 30.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Weight (kg)
Time Frame: Day 0 and Day 30
|
Body weight measured using Tanita BC-418 bioimpedance device.
|
Day 0 and Day 30
|
|
Height (cm)
Time Frame: Day 0 and Day 30
|
Height measured using a standard stadiometer.
|
Day 0 and Day 30
|
|
Body Mass Index (kg/m²)
Time Frame: Day 0 and Day 30
|
BMI calculated using the formula weight (kg)/height (m²).
|
Day 0 and Day 30
|
|
Waist Circumference (cm)
Time Frame: Day 0 and Day 30
|
Waist circumference measured with a flexible tape measure.
|
Day 0 and Day 30
|
|
Hip Circumference (cm)
Time Frame: Day 0 and Day 30
|
Hip circumference measured with a flexible tape measure.
|
Day 0 and Day 30
|
|
Chest Circumference (cm)
Time Frame: Day 0 and Day 30
|
Chest circumference measured using a flexible tape measure.
|
Day 0 and Day 30
|
|
Upper Arm Circumference (Right/Left, cm)
Time Frame: Day 0 and Day 30
|
Right and left upper arm circumferences measured with a flexible tape measure.
|
Day 0 and Day 30
|
|
Wrist Circumference (Right/Left, cm)
Time Frame: Day 0 and Day 30
|
Right and left wrist circumferences measured with a flexible tape measure.
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Day 0 and Day 30
|
|
Thigh Circumference (Right/Left, cm)
Time Frame: Day 0 and Day 30
|
Right and left thigh circumferences measured with a flexible tape measure.
|
Day 0 and Day 30
|
|
Calf Circumference (Right/Left, cm)
Time Frame: Day 0 and Day 30
|
Right and left calf circumferences measured with a flexible tape measure.
|
Day 0 and Day 30
|
|
Total Body Fat Mass (kg)
Time Frame: Day 0 and Day 30
|
Total body fat mass measured using Tanita BC-418.
|
Day 0 and Day 30
|
|
Total Body Fat Percentage (%)
Time Frame: Day 0 and Day 30
|
Total body fat percentage measured using Tanita BC-418.
|
Day 0 and Day 30
|
|
Abdominal Fat Mass (kg)
Time Frame: Day 0 and Day 30
|
Abdominal fat mass measured using Tanita BC-418.
|
Day 0 and Day 30
|
|
Regional Fat Percentages (Right/Left Arm & Leg)
Time Frame: Day 0 and Day 30
|
Regional fat percentages for arms and legs measured by Tanita BC-418.
|
Day 0 and Day 30
|
|
Total Muscle Mass (kg)
Time Frame: Day 0 and Day 30
|
Total muscle mass assessed using Tanita BC-418.
|
Day 0 and Day 30
|
|
Regional Muscle Mass (Right/Left Arm & Leg, kg)
Time Frame: Day 0 and Day 30
|
Regional muscle mass of arms and legs measured by Tanita BC-418.
|
Day 0 and Day 30
|
|
Basal Metabolic Rate (BMR)
Time Frame: Day 0 and Day 30
|
Basal metabolic rate calculated by Tanita BC-418.
|
Day 0 and Day 30
|
|
Metabolic Age
Time Frame: Day 0 and Day 30
|
Metabolic age estimated using Tanita BC-418 device.
|
Day 0 and Day 30
|
|
Total Body Water (kg)
Time Frame: Day 0 and Day 30
|
Total body water measured via bioimpedance analysis.
|
Day 0 and Day 30
|
|
Total Body Water Percentage (%)
Time Frame: Day 0 and Day 30
|
Total Body Water Percentage (%)
|
Day 0 and Day 30
|
|
WCST Total Correct Responses
Time Frame: Day 0 and Day 30
|
Total correct responses obtained from the Wisconsin Card Sorting Test.
|
Day 0 and Day 30
|
|
WCST Total Incorrect Responses
Time Frame: Day 0 and Day 30
|
Total incorrect responses measured using the Wisconsin Card Sorting Test.
|
Day 0 and Day 30
|
|
WCST Perseverative Error Count
Time Frame: Day 0 and Day 30
|
Perseverative errors recorded during the Wisconsin Card Sorting Test.
|
Day 0 and Day 30
|
|
WCST Total Time (seconds)
Time Frame: Day 0 and Day 30
|
Total time required to complete the Wisconsin Card Sorting Test.
|
Day 0 and Day 30
|
|
Trail Making Test A Completion Time (seconds)
Time Frame: Day 0 and Day 30
|
Completion time for Trail Making Test Part A.
|
Day 0 and Day 30
|
|
Trail Making Test B Completion Time (seconds)
Time Frame: Day 0 and Day 30
|
Completion time for Trail Making Test Part B.
|
Day 0 and Day 30
|
|
Biomarker Correlations (Irisin-Omentin-BDNF vs. Dose/Day)
Time Frame: Based on Day 30 measurements
|
Pearson correlation analysis examining relationships between biomarkers and intervention dose/day.
|
Based on Day 30 measurements
|
|
Safety Outcomes (Adverse Event Monitoring)
Time Frame: Continuous monitoring throughout 30 days
|
Monitoring of potential adverse events related to 300 mg/kg JOE administration.
|
Continuous monitoring throughout 30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: BÜLENT BAYRAKTAR, BAYBURT ÜNİVERSİTESİ
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BU-2025-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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