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

Not Applicable

Completed

• Conditions: Rice Mask; Rice Serum; Rice Jelly

• Registration Number: NCT06475222
• Lead Sponsor: Burapha University

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 Timeline

• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-06-20
• Study First Posted: 2024-06-26
• Study Start: 2024-09-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Concentration of interferon-gamma	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	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	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	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	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	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	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	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	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	Before and immediately after maximal oxygen consumption test	Study 3.2 determines level of superoxide dismutase activity in percentage (%) unit
Concentration of malondialdehyde	Before and immediately after maximal oxygen consumption test	Study 3.2 determines concentration of malondialdehyde in micromolar (uM) unit

Trial Locations

Locations (1)

Piyapong Prasertsri; 🇹🇭 Mueang, Chonburi, Thailand