Clinical trial NCT06227260: Body Massage Oil, Facial Mask, and Ready-to-drink Jelly From Snake Fruit
Official title: Development and Evaluation of Body Massage Oil, Facial Mask, and Ready-to-drink Jelly From Snake Fruit (Salacca Edulis Reinw.)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Body Massage Oil From Snake Fruit
Facial Mask From Snake Fruit
Jelly From Snake Fruit
Lead sponsor: Burapha University
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study 1 and 2 were parallel model, study 3 was crossover model.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Level of skin moisture
timeFrame: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12
measure: Level of skin elasticity
timeFrame: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12
measure: Level of skin oiliness
timeFrame: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12
measure: Level of skin melanin
timeFrame: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12
measure: Level of blood glucose
timeFrame: Before jelly consumption and after jelly consumption at 30, 60, 90, and 120 minutes
measure: Endurance time
timeFrame: After jelly consumption for 30 minutes
measure: Concentration of interferon-gamma
timeFrame: Before and immediately after endurance time test
measure: Concentration of tumor necrosis factor-alpha
timeFrame: Before and immediately after endurance time test
Secondary outcomes:
Other outcomes:
Locations:
city: Mueang
country: Thailand
facility: Faculty of Allied Health Sciences, Burapha University
state: ChonBuri
Study officials:
affiliation: Burapha University
name: Piyapong Prasertsri, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: