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Effect of shallot supplementation on overweight and obesity

Effects of Persian Shallot supplementation and lifestyle intervention on cardio-metabolic risk factors in overweight or obese children and adolescents: a randomized, double-blind, placebo-controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240213060993N2
Enrollment
100
Registered
2024-02-20
Start date
2024-03-05
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and obesity. Overweight and obesity

Interventions

Intervention 1: Intervention group: participants will receive 500 mg Persian shallot daily, for 8 weeks. participants will take part in a free online preventive intervention with the aim of promoting

Sponsors

National Institute of Medical Research Development of Iran
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: Children and adolescents aged 10-18 years Body Mass Index equal to or higher than the age- and sex-specific 85th percentile

Exclusion criteria

Exclusion criteria: Subjects with endocrine disorders Individuals with any physical disability Those using mineral and/or vitamin supplements History of chronic diseases and/or chronic medication use Individuals under special diets History of smoking, alcohol, and drug abuse

Design outcomes

Primary

MeasureTime frame
Total antioxidant capacities. Timepoint: At the beginning of the intervention to 8 weeks after intervention. Method of measurement: Human Total antioxidant capacity (TAOC)ELISA Kit.;Reactive oxygen species. Timepoint: At the beginning of the intervention to 8 weeks after intervention. Method of measurement: ROS assay kit and DCFDA fluorimetry.

Secondary

MeasureTime frame
Anthropometric indices. Timepoint: At the beginning of the intervention to 8 weeks after intervention. Method of measurement: Height will be measured by trained nutritionist to the nearest 0.1 cm with a portable stadiometer (SECA, Hamburg, Germany) without shoes. Weight will be measured to the nearest 0.1 kg with a balanced portable digital weight scale (SECA, Hamburg, Germany) with light indoor clothing and no shoes. Body mass index (BMI) will be calculated as weight (kg)/height2 (m). Waist circumference (WC) will be measured over the unclothed abdomen at the narrowest point between the rib cage and the superior border of the iliac crest using a nonelastic flexible tape to the nearest 0.1 cmHip circumference (HC) will be measured at the widest part of the hip at the level of the greater trochanter to the nearest 0.1 cm. Wrist circumference (WrC) will be measured to the nearest 0.1 cm on the dominant arm using a tape meter. Neck circumference (NC) will be measured with the most prominent portion of the thyroid cartilage taken as a landmark to the nearest 0.1 cm. Waist-Height Ratio (WHtR), and Waist-hip ratio (WHR), Abdominal Volume Index (AVI), Conicity Index (CI), and A Body Shape Index (ABSI) will be calculated using the following formulas:WHR: WC (cm) / HC (cm)WHtR: WC (cm) / Height (cm)AVI: (2 × WC2 (cm2) + 0.7 × [WC (cm) – HC (cm)]2) / 1000CI: WC (m) / 0.109 × v(Weight(kg) )/v(Height(m) )ABSI: WC/(BMI 2/3 Height 1/2).;Body composition. Timepoint: At the beginning of the intervention to 8 weeks after intervention. Method of measurement: Bioelectrical impedance analysis will be perfumed by InBody 720 Body Composition Analyzer (BioSpace Co., Ltd., Seoul, Korea). Sex, age, and height will be entered directly into the instrument prior to the impedance measure. Bare feet will be placed on the metal plates of the scale and the participant firmly grasp the hand grips while placing the thumb and fingers in the standard location as indicated in the operation manual. Th

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMotahar Heidari-Beni

Esfahan University of Medical Sciences

heidari.motahar@gmail.com+98 31 3792 5280

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026