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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 5400
        • Recruiting
        • University of Veterinary and Animal Sciences, Lahore
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Dietary supplement: Sea buckthorn aqueous infusion
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.
Dietary supplement: Sea buckthorn aqueous infusion
Sea buckthorn aqueous infusion prepared by using 5g powder in 250 ml water.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Veterinary and Animal Sciences, Lahore - Pakistan

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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