A 12-week randomized, double-blind, placebo-controlled clinical study for the evaluation of the body fat reduction efficacy and safety Salacilean from Salacia reticulata extract.

ADL Holdings1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2025年12月6日最近更新: 2026年2月23日

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 100
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

Obesity is a chronic and progressive disease with serious health consequences, but weight loss brings significant improvements in metabolic markers and overall health. Even small amounts of weight loss yield improvements in metabolic markers, with greater benefits observed as weight loss increases. Overweight and obesity, and a static body mass index (BMI) commonly conceal sarcopenia (gain in body fat but loss of muscle mass and functional capacity) in older people, aggravated by inactivity.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 19.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Adults aged between 19 and 65 who are healthy and capable of normal physical activity.
•Adults who belong to the range of BMI 25 – 34.9 kg per m2 and do not take drugs.
•Adults who voluntarily decide to participate and agree in writing to abide by the precautions after hearing a detailed explanation of the clinical study and fully understand it.

排除标准

•Clinical Study
•Adults who did not sign the research subject consent form
•Adults who participated in other clinical studies within 2 months before the screening test B.
•Subjects whose body weight has changed by 5-10 percent and whose weight gain or loss is 5kg or more within 3 months.
•Disease Status
•Subjects who have undergone obesity surgery within the last year
•Subjects who have undergone surgery within the last 6 months
•Subjects who are receiving or received psychotropic drug treatment and psychological treatment due to mental disorders (depression, schizophrenia)
•Patients with cardiovascular disease, arrhythmia, heart failure, myocardial infarction, cerebrovascular disease, and those with a history of using a cardiac pacemaker
•Patients with diabetes who are under medication or cannot be controlled 9.Gastrointestinal disease (Crohn’s disease)/gastric resection/irritable bowel syndrome
•Chronic inflammation (kidney, liver, pancreas) and infectious diseases, hypertension (systolic/diastolic 160/100mmHg or more)
•Patients with a history of heart disease or cancer
•Patients with thyroid disease or those taking thyroid drug substitutes
•Patients with malabsorption syndrome/ autoimmune disease
•Patients with liver and kidney failure
•Subjects taking dietary supplements or drugs that may affect blood sugar and lipid metabolism, body composition, and eicosanoid production (e.g., salicylates, dairy products)
•Patients with anaemia/ porphyria)
•Subjects suffering from pancreatic disease, those with a history of eating disorders.
•Physiological status
•Women who are pregnant or lactating
•Women within 6 months of giving birth E.
•Medication and health functional food products
•Subjects taking anti-obesity drugs
•Drug addicted subjects
•Subjects who are taking blood sugar lowering drugs, insulin, or diabetes medications
•Subjects who are taking drugs that affect energy metabolism, blood sugar, appetite, and gastrointestinal activity
•Subjects taking immunosuppressants, proton pump inhibitors (PPI), H2 blockers, and non steroidal anti-inflammatory drugs
•Subjects who are taking health functional food products for reducing body fat F.
•Life Habit
•Subjects who have been on weight management for the past few years
•Subjects who consume excessive alcohol (exceeding 2g per day MFDS Guidelines) Ingested alcohol content (g): Intake (ml) x alcohol content (%) x 0.8 (alcohol specific gravity)/
•Excessive smokers (more than 25 cigarettes per day) G.
•Allergy 32 Subjects with allergies/ side effects to the test substance excluded from the study H.
•Subjects with serum creatinine 1.5mg/dL or higher
•Subject whose AST (aspartate aminotransferase) and ALT (alanine aminotransferase) level is three times or more than the maximum normal level
•Subject who is judged unsuitable for the human application test by the researcher
•Hepatitis B or C carriers.
•Subjects who are judged unfit to participate in the research by the research director due to other reasons.

研究者

发起方

ADL Holdings

申办方类型

Other [Nutraceutical supplement company]

责任方

Principal Investigator

主要研究者

Dr Lokesh S

The Oxford Medical College, Hospital and Research Centre

研究点 (1)

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