Facial Serum and Mask and Ready-to-drink Jelly From Thai Rice

Development and Effectiveness Evaluation of Facial Serum and Mask and Ready-to-drink Jelly From Thai Rice (Oryza Sativa L.)

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.

Study Overview

• Status: Completed
• Conditions: Rice Serum; Rice Mask; Rice Jelly
• Intervention / Treatment: Other: Study 1: Facial serum with alpha albutin; Other: Study 1: Facial serum with Tubtim Chumpae rice extract; Other: Study 2: Facial mask with Hom Pathum rice extract; Other: Study 3: Control jelly; Other: Study 3: Jelly with Tubtim Chumpae rice; Other: Study 3: Jelly with Hom Pathum rice

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chonburi
    • Mueang, Chonburi, Thailand, 20131
      • Piyapong Prasertsri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study 1: Facial serum with alpha albutin; Participants will be randomly applied with home-based program of facial serum producing from 2% alpha albutin (standard facial serum) on either right side or left side of their face daily for 12 weeks.	Other: Study 1: Facial serum with alpha albutin; Applying with facial serum with 2% alpha albutin as active comparator daily for 12 weeks.
Experimental: Study 1: Facial serum with Tubtim Chumpae rice extract; Participants will be randomly applied with home-based program of facial serum producing from Tubtim Chumpae rice extract on either right side or left side of their face daily for 12 weeks.	Other: Study 1: Facial serum with Tubtim Chumpae rice extract; Applying with facial serum with Tubtim Chumpae rice extract as experimental intervention daily for 12 weeks.
Experimental: Study 2: Facial mask with Hom Pathum rice extract; Participants will receive home-based program of facial mask with Hom Pathum rice extract for 30 min/day, 2 days/week for 12 weeks.	Other: Study 2: Facial mask with Hom Pathum rice extract; Applying with facial mask with Hom Pathum rice extract as experimental intervention for 30 min/day, 2 days/week for 12 weeks.
Active Comparator: Study 3: Control jelly; Participants will consume with control jelly at 3.5 g/kg body weight. Consumption will be taken at Burapha University.	Other: Study 3: Control jelly; Consumption with control jelly as active comparator at 3.5 g/kg body weight.
Experimental: Study 3: Jelly with Tubtim Chumpae rice; Participants will consume with Tubtim Chumpae rice jelly at 3.5 g/kg body weight. Consumption will be taken at Burapha University.	Other: Study 3: Jelly with Tubtim Chumpae rice; Consumption with jelly with Tubtim Chumpae rice as experimental intervention at 3.5 g/kg body weight.
Experimental: Study 3: Jelly with Hom Pathum rice; Participants will consume with Hom Pathum rice jelly at 3.5 g/kg body weight. Consumption will be taken at Burapha University.	Other: Study 3: Jelly with Hom Pathum rice; Consumption with jelly with Hom Pathum rice as experimental intervention at 3.5 g/kg body weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of skin moisture	Studies 1 and 2 determine 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	Studies 1 and 2 determine 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	Studies 1 and 2 determine 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	Studies 1 and 2 determine 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	Study 3.1 determines level of blood glucose in mg/dL unit	Before jelly consumption and after jelly consumption at 30, 60, 90, and 120 minutes
Level of maximal oxygen consumption	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.	After jelly consumption for 30 minutes
Concentration of interferon-gamma	Study 3.2 determines concentration of interferon-gamma in serum in pg (picogram)/mL unit	Before and immediately after maximal oxygen consumption test
Concentration of tumor necrosis factor-alpha	Study 3.2 determines concentration of tumor necrosis factor-alpha in serum in pg (picogram)/mL unit	Before and immediately after maximal oxygen consumption test
Concentration of interleukin-10	Study 3.2 determines concentration of interleukin-10 in serum in pg (picogram)/mL unit	Before and immediately after maximal oxygen consumption test
Level of superoxide dismutase activity	Study 3.2 determines level of superoxide dismutase activity in percentage (%) unit	Before and immediately after maximal oxygen consumption test
Concentration of malondialdehyde	Study 3.2 determines concentration of malondialdehyde in micromolar (uM) unit	Before and immediately after maximal oxygen consumption test

Collaborators and Investigators

• Sponsor: Burapha University
• Investigators: Principal Investigator: Piyapong Prasertsri, Ph.D., Burapha University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Thai rice
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: IRB1-047/2567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No