Sea Buckthorn Aqueous Infusion Impact (Sbaii)

University of Veterinary and Animal Sciences, Lahore - Pakistan

Status: Enrolling

Conditions: Body Compostition

Treatments: Dietary Supplement: Sea buckthorn aqueous infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT07313423

UVAS2

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Sea buckthorn aqueous infusion

2

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Sea buckthorn aqueous infusion