Development and Effectiveness Evaluation of Facial Serum and Mask and Ready-to-drink Jelly From Thai Rice (Oryza Sativa L.)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Burapha University
- Enrollment
- 104
- Locations
- 2
- Primary Endpoint
- Concentration of interferon-gamma
Study Overview
Brief Summary
This study consisted of three sub-studies including 1) development and evaluation of facial serum from Thai rice on skin moisture, elasticity, oiliness, and melanin in healthy participants 2) development and evaluation of facial mask from Thai rice on skin moisture, elasticity, oiliness, and melanin in healthy participants and 3) development and evaluation of ready-to-drink jelly from Thai rice on controlling blood glucose and endurance time in healthy participants.
Detailed Description
Study 1: 30 male and female participants, age 30-50 years will be randomly applied with facial serum producing from either 2% alpha albutin (standard facial serum) or Tubtim Chumphae rice extract on either right side or left side of their face daily for 12 weeks.
Study 2: 60 male and female participants, age 30-50 years will be randomly assigned into 2 groups including 1) control group (n = 30): participants will not receive any facial mask for 12 weeks and 2) treatment group (n = 30): participants will be applied with home-based program facial mask with Hom Pathum rice extract for 30 min/day, 2 days/week for 12 weeks.
Study 3: this study consists of 2 sub-studies. Study 3.1: 25 male and female participants, age 18-35 years will be randomly consumed with control jelly, jelly with Tubtim Chumphae rice, and jelly with Hom Pathum rice at 3.5 g/kg body weight. All participants will be measured for blood glucose levels before consumption and after consumption at 30, 60, 90, and 120 min. Study 3.2: 25 male and female participants, age 18-35 years will be randomly consumed with control jelly, jelly with Tubtim Chumphae rice, and jelly with Hom Pathum rice at 3.5 g/kg body weight. After each consumption, all participants will perform walking or running on treadmill at intensity of 80% maximal heart rate to measure maximal oxygen consumption.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female
- •Age between 18 to 50 years
- •Interested in facial serum with Thai rice extract or facial mask with Thai rice extract or jelly from with Thai rice
Exclusion Criteria
- •History of adverse effects from facial serum or mask application or jelly consumption
- •Skin allergy
- •Skin disorders
- •Skin wounds
- •History of allergy to Thai rice, particularly in Tubtim Chumpae and Hom Pathum
- •History of allergy to facial serum or mask, i.e., serum or mask from rice
- •History of allergy to 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
Outcomes
Primary Outcomes
Concentration of interferon-gamma
Time Frame: Before and immediately after maximal oxygen consumption test
Study 3.2 determines concentration of interferon-gamma in serum in pg (picogram)/mL unit
Level of skin elasticity
Time Frame: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12]
Studies 1 and 2 determine level of skin elasticity in arbitrary unit (no unit) using Multiprobe Adapter System with Cutometer® 580 probe.
Level of skin moisture
Time Frame: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12]
Studies 1 and 2 determine level of skin moisture in arbitrary unit (no unit) using Multiprobe Adapter System with Corneometer® CM 825 probe.
Concentration of interleukin-10
Time Frame: Before and immediately after maximal oxygen consumption test
Study 3.2 determines concentration of interleukin-10 in serum in pg (picogram)/mL unit
Level of skin oiliness
Time Frame: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12]
Studies 1 and 2 determine level of skin oiliness in arbitrary unit (no unit) using Multiprobe Adapter System with Sebumeter® SM 815 probe.
Level of skin melanin
Time Frame: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12]
Studies 1 and 2 determine level of skin melanin in arbitrary unit (no unit) using Multiprobe Adapter System with Mexameter® MX18 probe.
Level of blood glucose
Time Frame: Before jelly consumption and after jelly consumption at 30, 60, 90, and 120 minutes
Study 3.1 determines level of blood glucose in mg/dL unit
Level of maximal oxygen consumption
Time Frame: After jelly consumption for 30 minutes
Study 3.2 determines level of maximal oxygen consumption in mL/kg/min unit by walking or running on treadmill at intensity of 80% maximal heart rate.
Concentration of tumor necrosis factor-alpha
Time Frame: Before and immediately after maximal oxygen consumption test
Study 3.2 determines concentration of tumor necrosis factor-alpha in serum in pg (picogram)/mL unit
Level of superoxide dismutase activity
Time Frame: Before and immediately after maximal oxygen consumption test
Study 3.2 determines level of superoxide dismutase activity in percentage (%) unit
Concentration of malondialdehyde
Time Frame: Before and immediately after maximal oxygen consumption test
Study 3.2 determines concentration of malondialdehyde in micromolar (uM) unit
Secondary Outcomes
No secondary outcomes reported
Investigators
Piyapong Prasertsri
Associate Professor Dr.
Burapha University