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

NCT06475222 | Completed DMC

• 1 other identifier: IRB1-047/2567
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Rice Serum; Rice Mask; Rice Jelly

Keywords

Thai rice

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (6)

Study 1: Facial serum with alpha albutin

ACTIVE COMPARATOR

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

Study 1: Facial serum with Tubtim Chumpae rice extract

EXPERIMENTAL

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

Study 2: Facial mask with Hom Pathum rice extract

EXPERIMENTAL

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

Study 3: Control jelly

ACTIVE COMPARATOR

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

Study 3: Jelly with Tubtim Chumpae rice

EXPERIMENTAL

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

Study 3: Jelly with Hom Pathum rice

EXPERIMENTAL

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

Interventions

Study 1: Facial serum with alpha albutin OTHER

Applying with facial serum with 2% alpha albutin as active comparator daily for 12 weeks.

Study 1: Facial serum with alpha albutin

Study 1: Facial serum with Tubtim Chumpae rice extract OTHER

Applying with facial serum with Tubtim Chumpae rice extract as experimental intervention daily for 12 weeks.

Study 1: Facial serum with Tubtim Chumpae rice extract

Study 2: Facial mask with Hom Pathum rice extract OTHER

Applying with facial mask with Hom Pathum rice extract as experimental intervention for 30 min/day, 2 days/week for 12 weeks.

Study 2: Facial mask with Hom Pathum rice extract

Study 3: Control jelly OTHER

Consumption with control jelly as active comparator at 3.5 g/kg body weight.

Study 3: Control jelly

Study 3: Jelly with Tubtim Chumpae rice OTHER

Consumption with jelly with Tubtim Chumpae rice as experimental intervention at 3.5 g/kg body weight.

Study 3: Jelly with Tubtim Chumpae rice

Study 3: Jelly with Hom Pathum rice OTHER

Consumption with jelly with Hom Pathum rice as experimental intervention at 3.5 g/kg body weight.

Study 3: Jelly with Hom Pathum rice

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Burapha University: lead

Study Sites (1)

Piyapong Prasertsri

Mueang, Changwat Chon Buri, 20131, Thailand

Location

Study Officials

• Piyapong Prasertsri, Ph.D.

  Burapha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Model Details: Study 1 is single group model, study 2 is parallel model, and study 3 is crossover model.

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: September 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)