- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06227260
Body Massage Oil, Facial Mask, and Ready-to-drink Jelly From Snake Fruit
Development and Evaluation of Body Massage Oil, Facial Mask, and Ready-to-drink Jelly From Snake Fruit (Salacca Edulis Reinw.)
Study Overview
Status
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).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
ChonBuri
-
Mueang, ChonBuri, Thailand, 20131
- Faculty of Allied Health Sciences, Burapha University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Study 1: Thai massage
Participants were randomized to receive an arm.
In this arm, participants received Thai massage without any oil for 1 hour/day, 1 day/week for 12 weeks.
Massage was performed at Burapha University by an expert.
|
Interventions among the 3 studies were categorized as other.
|
|
Active Comparator: Study 1: Thai massage with pure coconut oil
Participants were randomized to receive an arm.
In this arm, 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.
Massage was performed at Burapha University by an expert.
|
Interventions among the 3 studies were categorized as other.
|
|
Experimental: Study 1: Thai massage with oil mixed with Snake fruit extract
Participants were randomized to receive an arm.
In this arm, participants received Thai massage with oil mixed with Snake fruit extract for 1 hour/day, 1 day/week for 12 weeks.
Massage was performed at Burapha University by an expert.
|
Interventions among the 3 studies were categorized as other.
|
|
Experimental: Study 2: Facial mask with Snake fruit extract
Participants were randomized to receive an arm.
In this arm, participants received home-based program facial mask with Snake fruit extract for 30 min/day, 2 days/week for 12 weeks.
|
Interventions among the 3 studies were categorized as other.
|
|
Active Comparator: Study 3: Control jelly
Participants were randomized to receive an arm.
In this arm, participants consumed with control jelly at 3.5 g/kg body weight.
Consumption was taken at Burapha University.
|
Interventions among the 3 studies were categorized as other.
|
|
Experimental: Study 3: Jelly with Snake fruit juice
Participants were randomized to receive an arm.
In this arm, participants consumed with jelly with Snake fruit juice at 3.5 g/kg body weight.
Consumption was taken at Burapha University.
|
Interventions among the 3 studies were categorized as other.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of skin moisture
Time Frame: 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
|
Before intervention, immediately after intervention, ends of week 4, week 8, and week 12
|
|
Level of skin elasticity
Time Frame: 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
|
Before intervention, immediately after intervention, ends of week 4, week 8, and week 12
|
|
Level of skin oiliness
Time Frame: 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
|
Before intervention, immediately after intervention, ends of week 4, week 8, and week 12
|
|
Level of skin melanin
Time Frame: 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
|
Before intervention, immediately after intervention, ends of week 4, week 8, and week 12
|
|
Level of blood glucose
Time Frame: 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
|
Before jelly consumption and after jelly consumption at 30, 60, 90, and 120 minutes
|
|
Endurance time
Time Frame: 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)
|
After jelly consumption for 30 minutes
|
|
Concentration of interferon-gamma
Time Frame: Before and immediately after endurance time test
|
Study 3.2 determined concentration of interferon-gamma in serum in pg (picogram)/mL unit
|
Before and immediately after endurance time test
|
|
Concentration of tumor necrosis factor-alpha
Time Frame: Before and immediately after endurance time test
|
Study 3.2 determined concentration of tumor necrosis factor-alpha in serum in pg (picogram)/mL unit
|
Before and immediately after endurance time test
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Piyapong Prasertsri, Ph.D., Burapha University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB1-028/2566
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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