- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07313423
Sea Buckthorn Aqueous Infusion Impact (Sbaii)
December 17, 2025 updated by: Qaisar Raza, University of Veterinary and Animal Sciences, Lahore - Pakistan
Sea Buckthorn Aqueous Infusion Impact on Body Composition Metrics Among Overweight Female Adults.
- A total of 60 overweight women (BMI 25-29.9 kg/m²), aged 18-50years, will be enrolled and randomized equally into intervention and control groups. The intervention group will consume a 5 g freshly prepared seabuckthorn aqueous infusion daily for 12 weeks, while controls maintain usual habits without supplementation.
- The seabuckthorn aqueous infusion will be prepared by using 250mL of potable boiled water and then cooled to a lukewarm temperature (around 40-45°C). At this point, 5 g of seabuckthorn powder will be added, stirred thoroughly until fully dispersed, and consumed immediately. The infusion will be freshly prepared once daily and administered in the morning after breakfast.
Measurements will be conducted using the InBody 270, a validated bioelectrical impedance analyzer employed in this study to obtain accurate assessments of body weight, body mass index (BMI), waist-hip ratio, and visceral fat levels. The device offers segmental analysis and visceral fat estimation through non-invasive, standardized procedures, ensuring consistency and reliability in longitudinal tracking.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Background: Overweight and obesity have become major public health challengesdisproportionately affecting adult women worldwide, including Pakistan.
Functional foodsare gaining attention for their preventive and therapeutic potential, with Sea buckthornemerging as a promising option due to its rich bioactive composition which exhibit antioxidant, anti-inflammatory, and lipid-regulating properties.
This research, therefore, seeks to evaluate the effects of sea buckthorn consumption on female body composition, exploring its role as a nutritional intervention for weight management and metabolic health.
Hypothesis: Participants consuming sea buckthorn aqueous infusion showsignificant declines in BMI, body weight, visceral fat, and waist-hip ratio.
Methodology : A total of 60 overweight women (BMI 25-29.9
kg/m²), aged 18-50years, will be enrolled and will be randomly allocated to intervention and control groups.
Theintervention group will consume freshly prepared seabuckthorn aqueous infusion dailyfor12 weeks, while controls maintain usual habits without supplementation.
Data analysis : Data will be analyzed using SPSS version 25.
Baseline characteristicsbetween groups will be compared using Descriptive statistics (mean ± SD) as appropriate.
Between-group comparisons differences will be analyzed using ANOVA.
Statistical significance will be set at p < 0.05.
Outcome : Supplementation with seabuckthorn aqueous infusion over a 12-weekperiodwill result in notable improvements in body composition measures among overweight female adults.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eesha Naeem, Post graduate
- Phone Number: +923264095787
- Email: eeshanaeem22@gamil.com
Study Contact Backup
- Name: Dr. Qaisar Raza, Phd
- Phone Number: +923002479044
- Email: qaisar.raza@uvas.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 5400
- Recruiting
- University of veterinary and animal sciences, Lahore
-
Contact:
- Dr. Qaisar Raza, Phd
- Phone Number: +923002479044
- Email: qaisar.raza@gmail.com
-
Principal Investigator:
- Dr. Qaisar Raza, Phd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion criteria females, age 18-50, bmi greater or equal to 25. exclusion criteria current pregnancy or lactation, a history of chronic metabolic or gastrointestinal diseases, use of weight management drugs or supplements, known allergies to sea buckthorn or other documented intolerances, smoking or alcohol consumption, a physical activity level exceeding 1.4, and prior participation in weight loss research programs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 1
The participants in the control group will consume placebo that will match in appearance to the supplement and is used to maintain blinding.
Participants will consume freshly prepared sea buckthorn aqueous infusion daily for 12 weeks.
|
Sea buckthorn aqueous infusion prepared by using 5g powder in 250 ml water.
|
|
Experimental: 2
Drug (Sea buckthorn aqueous infusion) The participants will consume Sea buckthorn aqueous infusion supplementation daily for 12 weeks.
it will be prepared by using 5g sb powder in 250 ml of water.
|
Sea buckthorn aqueous infusion prepared by using 5g powder in 250 ml water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body weight
Time Frame: 12 weeks
|
unit of measurement in kilograms will be measured by weight machine
|
12 weeks
|
|
Body mass index
Time Frame: at the end of intervention (12 week)
|
body mass index will be measured using body mass index calculator
|
at the end of intervention (12 week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visceral fat
Time Frame: at the end of intervention period (12 week)
|
visceral fat will be measured using bioelectric impedance analysis
|
at the end of intervention period (12 week)
|
|
waist-hip ratio
Time Frame: at the end of intervention period ( 12 week)
|
waist hip ratio will be measured using measuring tape
|
at the end of intervention period ( 12 week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2026
Primary Completion (Estimated)
March 30, 2026
Study Completion (Estimated)
April 15, 2026
Study Registration Dates
First Submitted
December 17, 2025
First Submitted That Met QC Criteria
December 17, 2025
First Posted (Estimated)
January 2, 2026
Study Record Updates
Last Update Posted (Estimated)
January 2, 2026
Last Update Submitted That Met QC Criteria
December 17, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- UVAS2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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