Clinical trial NCT06475222: Facial Serum and Mask and Ready-to-drink Jelly From Thai Rice
Official title: Development and Effectiveness Evaluation of Facial Serum and Mask and Ready-to-drink Jelly From Thai Rice (Oryza Sativa L.)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rice Serum
Rice Mask
Rice Jelly
Keywords: Thai rice
Lead sponsor: Burapha University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Study 1 is single group model, study 2 is parallel model, and study 3 is crossover model.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Age between 18 to 50 years
* Healthy
* 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

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: Level of maximal oxygen consumption
timeFrame: After jelly consumption for 30 minutes
measure: Concentration of interferon-gamma
timeFrame: Before and immediately after maximal oxygen consumption test
measure: Concentration of tumor necrosis factor-alpha
timeFrame: Before and immediately after maximal oxygen consumption test
measure: Concentration of interleukin-10
timeFrame: Before and immediately after maximal oxygen consumption test
measure: Level of superoxide dismutase activity
timeFrame: Before and immediately after maximal oxygen consumption test
measure: Concentration of malondialdehyde
timeFrame: Before and immediately after maximal oxygen consumption test
Secondary outcomes:
Other outcomes:
Locations:
city: Mueang
country: Thailand
facility: Piyapong Prasertsri
state: Chonburi
Study officials:
affiliation: Burapha University
name: Piyapong Prasertsri, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: