Effect of Double Nutri® Liposomal Encapsulation Technology on Human Absorption of Glucosamine Supplements
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Plasma glucosamine level (ng/mL)
研究概览
简要总结
The objective of this study is to evaluate the effects of liposomal encapsulation using different ratios of gum arabic and lecithin on the bioavailability of a liquid glucosamine supplement in humans.
详细描述
This study is a single-center, self-controlled crossover human trial designed to evaluate the differences in blood concentration changes and bioavailability following a single oral dose of glucosamine supplements.
Healthy adult participants aged 18 years and older will be enrolled. Each participant will complete four study sessions, with a minimum washout period of 7 days between sessions. On each study day, venous blood samples will be collected prior to test product administration (0 minutes) to assess glucosamine levels, complete blood count, blood lipids, blood glucose, and liver and kidney function indicators.
After baseline blood collection, a standardized breakfast will be provided and consumed within 10 minutes, followed by administration of the test product. Venous blood samples will then be collected at 0.5, 1, 2, 4, 8, and 24 hours post-intake to measure glucosamine concentrations. Lunch will be provided after the 4-hour blood draw, and dinner will be provided after the 8-hour blood draw. Identical meals will be provided on four study sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged ≥18 years, regardless of sex, who are willing to sign the informed consent form and are able to fully comply with all study procedures.
排除标准
- •Pregnant or breastfeeding women, or individuals who are unwilling to use a physical method of contraception during the study period, such as condoms or an intrauterine device.
- •Employees of TCI Co., Ltd. and their family members.
- •Individuals who have regularly taken any supplements or medications containing glucosamine or N-acetylglucosamine (N-acetyl-glucosamine) within 14 days prior to study initiation, defined as use for ≥7 consecutive days.
- •Individuals with a history of chronic gastrointestinal disorders, including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), chronic diarrhea, Crohn's disease, celiac disease, bowel control problems/fecal incontinence, pancreatitis, peptic ulcer disease, colorectal cancer, short bowel syndrome, or ulcerative colitis; a history of epilepsy or seizures; liver or kidney disease; malignancy; endocrine disorders; psychiatric disorders; alcohol or substance abuse; or other significant organic diseases, as determined based on medical history.
- •Individuals with a history of gastrointestinal surgery, organ transplantation, or other major surgery.
- •Individuals who have experienced acute gastroenteritis within 2 weeks prior to study initiation.
- •Individuals with a history of allergy to any ingredient in the investigational products. The investigational products contain shrimp- and soy-derived ingredients.
- •Vegetarians, as the glucosamine used in this study is derived from shrimp.
研究组 & 干预措施
High-Emulsified Liposomal Glucosamine Liquid
One sachet will be administered per dose, with each sachet containing 1,500 mg of glucosamine.
干预措施: High-Emulsified Liposomal Glucosamine Liquid (Dietary Supplement)
Low-Emulsified Liposomal Glucosamine Liquid
One sachet will be administered per dose, with each sachet containing 1,500 mg of glucosamine.
干预措施: Low-Emulsified Liposomal Glucosamine Liquid (Dietary Supplement)
Glucosamine Liquid without Liposomal
One sachet will be administered per dose, with each sachet containing 1,500 mg of glucosamine.
干预措施: Glucosamine Liquid without Liposomal (Dietary Supplement)
Glucosamine tablet without Liposomal
Three tablets will be administered per dose, with each tablet containing 500 mg of glucosamine.
干预措施: Glucosamine Tablet without Liposomal (Dietary Supplement)
结局指标
主要结局
Plasma glucosamine level (ng/mL)
时间窗: at 24 hours after taking test sample
Plasma glucosamine levels will be measured at fasting and at 0.5, 1, 2, 4, 8, and 24 hours post-intake.
次要结局
未报告次要终点