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临床试验/NCT06227260
NCT06227260已完成2 期

Development and Evaluation of Body Massage Oil, Facial Mask, and Ready-to-drink Jelly From Snake Fruit (Salacca Edulis Reinw.)

Burapha University2 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2023年3月20日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
178
试验地点
2
主要终点
Level of skin elasticity

研究概览

简要总结

This study consisted of three sub-studies including 1) development and evaluation of body massage oil from Snake fruit on skin moisture, elasticity, oiliness, and melanin in healthy participants 2) development and evaluation of facial mask from Snake fruit on skin moisture, elasticity, oiliness, and melanin in healthy participants and 3) development and evaluation of ready-to-drink jelly from Snake fruit on controlling blood glucose and endurance time in healthy participants.

详细描述

Study 1: senventy-one male and female participants, aged 23.99 ± 5.68 years were randomly assigned into 3 groups including 1) control group (n = 23): participants received Thai massage without any oil for 1 hour/day, 1 day/week for 12 weeks 2) treatment-1 group (n = 23): participants received Thai massage with pure coconut oil which is a popular oil used in spa for 1 hour/day, 1 day/week for 12 weeks and 3) treatment-2 group (n = 25): participants received Thai massage with oil mixed with Snake fruit extract for 1 hour/day, 1 day/week for 12 weeks.

Study 2: fifty-nine male and female participants, aged 23.39 ± 4.84 years were randomly assigned into 2 groups including 1) control group (n = 29): participants did not receive any facial mask for 12 weeks and 2) treatment group (n = 30): participants received home-based program facial mask with Snake fruit extract for 30 min/day, 2 days/week for 12 weeks.

Study 3: this study was divided into 2 sub-stidies. Study 3.1: twenty-five male and female participants, aged 22.60 ± 3.33 years were randomly consumed with either control jelly or jelly with Snake fruit juice at 3.5 g/kg body weight. All participants were analyzed for blood glucose level before consumption and after consumption at 30, 60, 90, and 120 min. Study 3.2: twenty-three male and female participants, aged 21.57 ± 1.88 years were randomly consumed with either control jelly or jelly with Snake fruit juice at 3.5 g/kg body weight. After each consumption, all participants performed leg cycling at intensity 60% of maximal oxygen consumption as long as tolerance (time to exhaustion test).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Man or woman
  • Aged between 18 to 35 years
  • Interested in body massage with oil or facial mask or jelly from Snake fruit

排除标准

  • History of adverse effects from body massage
  • Skin allergy
  • Skin disorders
  • Skin wounds
  • History of allergy to coconut or plant oil
  • History of allergy to facial mask, i.e., mask from fruit
  • History of allergy to Snake fruit or gelatin
  • Signs or symptoms of fever or infection
  • Abnormal body mass index
  • Regular smokers or alcohol drinkers (>2 times per week)
  • Regular exerciser (>2 times per week or >150 min per week)
  • Regular intake of dietary supplements, i.e., vitamins, antioxidants
  • Hypertension, diabetes, cardiovascular disease, respiratory disease, endocrine disease, neuromuscular disease, musculoskeletal disease, liver disease, renal disease, immune disease, infectious disease, or cancer

结局指标

主要结局

Level of skin elasticity

时间窗: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12

Study 1 and 2 determined level of skin elasticity in arbitrary unit (no unit) using Multiprobe Adapter System with Cutometer® 580 probe

Level of skin moisture

时间窗: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12

Study 1 and 2 determined level of skin moisture in arbitrary unit (no unit) using Multiprobe Adapter System with Corneometer® CM 825 probe

Level of skin melanin

时间窗: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12

Study 1 and 2 determined level of skin melanin in arbitrary unit (no unit) using Multiprobe Adapter System with Mexameter® MX18 probe

Endurance time

时间窗: After jelly consumption for 30 minutes

Study 3.2 determined endurance time by cycling at 60% of maximum oxygen consumption as long as possible (time to exhaustion test)

Concentration of tumor necrosis factor-alpha

时间窗: Before and immediately after endurance time test

Study 3.2 determined concentration of tumor necrosis factor-alpha in serum in pg (picogram)/mL unit

Level of skin oiliness

时间窗: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12

Study 1 and 2 determined level of skin oiliness in arbitrary unit (no unit) using Multiprobe Adapter System with Sebumeter® SM 815 probe

Concentration of interferon-gamma

时间窗: Before and immediately after endurance time test

Study 3.2 determined concentration of interferon-gamma in serum in pg (picogram)/mL unit

Level of blood glucose

时间窗: Before jelly consumption and after jelly consumption at 30, 60, 90, and 120 minutes

Study 3.1 determined level of blood glucose in mg/dL unit

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Piyapong Prasertsri

Associate Professor Dr.

Burapha University

研究点 (2)

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