Body Massage Oil, Facial Mask, and Ready-to-drink Jelly From Snake Fruit

Phase 2

Completed

• Conditions: Facial Mask From Snake Fruit; Body Massage Oil From Snake Fruit; Jelly From Snake Fruit
• Interventions: Other: Thai massage, Thai massage with pure coconut oil, Thai massage with oil mixed with Snake fruit extract, Control, Facial mask with Snake fruit extract, Control jelly, Jelly with Snake fruit juice

• Registration Number: NCT06227260
• Lead Sponsor: Burapha University

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).

Study Timeline

• Study Start: 2023-03-20
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-31
• Study First Submitted: 2023-12-21
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-17
• Last Update Submitted: 2024-01-17
• Study First Posted: 2024-01-26
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study 3: Jelly with Snake fruit juice	Thai massage, Thai massage with pure coconut oil, Thai massage with oil mixed with Snake fruit extract, Control, Facial mask with Snake fruit extract, Control jelly, 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.
Study 1: Thai massage with pure coconut oil	Thai massage, Thai massage with pure coconut oil, Thai massage with oil mixed with Snake fruit extract, Control, Facial mask with Snake fruit extract, Control jelly, Jelly with Snake fruit juice	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.
Study 3: Control jelly	Thai massage, Thai massage with pure coconut oil, Thai massage with oil mixed with Snake fruit extract, Control, Facial mask with Snake fruit extract, Control jelly, Jelly with Snake fruit juice	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.
Study 1: Thai massage	Thai massage, Thai massage with pure coconut oil, Thai massage with oil mixed with Snake fruit extract, Control, Facial mask with Snake fruit extract, Control jelly, Jelly with Snake fruit juice	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.
Study 1: Thai massage with oil mixed with Snake fruit extract	Thai massage, Thai massage with pure coconut oil, Thai massage with oil mixed with Snake fruit extract, Control, Facial mask with Snake fruit extract, Control jelly, Jelly with Snake fruit juice	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.
Study 2: Facial mask with Snake fruit extract	Thai massage, Thai massage with pure coconut oil, Thai massage with oil mixed with Snake fruit extract, Control, Facial mask with Snake fruit extract, Control jelly, Jelly with Snake fruit juice	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.

Primary Outcome Measures

Name	Time	Method
Level of skin elasticity	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	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	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	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	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	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	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	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

Trial Locations

Locations (1)

Faculty of Allied Health Sciences, Burapha University; 🇹🇭 Mueang, ChonBuri, Thailand