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Completed

NCT Number: NCT06475222

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

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.

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Key information

Conditions

Rice Serum Rice Jelly Rice Mask

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Piyapong Prasertsri

Mueang, Changwat Chon Buri, 20131, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 Tubtim Chumpae rice extract

Other

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

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 3: Control jelly

Other

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

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 Hom Pathum rice

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

  11. Concentration of malondialdehyde

    Time frame: Before and immediately after maximal oxygen consumption test

    Study 3.2 determines concentration of malondialdehyde in micromolar (uM) unit

Sponsors and collaborators

Lead sponsor

Burapha University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.