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IRCT20201226049840N1 IRCT 2021-04-13 Shahid Beheshti University of Medical Sciences Designing a Dietary Supplement to Promote Skin Health Formulation of ِDietary Supplement Using Collagen, Ornithine and Probiotic and its Evaluation on Skin Health Factors in Healthy People: A Double-Blind Randomized Controlled Trial 2021-06-22 anticipated 70 Complete https://irct.ir/trial/55412 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization: Individuals will be assigned to intervention and placebo groups using cards marked 'A' or 'B'. Codes A and B will be written in 70 numbers. So there will be 35 cards A and 35 cards B. After visiting each volunteer, one of these cards will be randomly selected, which will be indicated on the volunteer number card and its group type, Blinding description: None of the people involved in the study, nor any of the interveners, will be aware of the type of intervention being performed on the individuals.The placebo will be completely similar to the formulated powder in terms of appearance, texture and taste, because the same essential oil and color will be used in the placebo and the optimized formula. 3 Healthy subjects. Intervention 1: Intervention group: In this group, on the first day, skin health indicators such as moisture, pH, elasticity, pigment and water loss through the epidermis will be measured. Then, the participants will be trained which dissolve 1 sachet containing collagen, ornithine and probiotic compounds in 200 ml of milk or water daily and eat it as a snack. One sachet will be consumed daily for 60 days during the intervention. Then, at the end of the study, the mentioned skin health indicators will be measured again. Intervention 2: Control group: In this group, on the first day, skin health indicators such as moisture, pH, elasticity, pigment and water loss through the epidermis will be measured. Then, the participants will be trained which dissolve 1 sachet of maltodextrin compounds (22 g) in 200 ml of milk or water daily and eat it as a snack. One sachet will be consumed daily for 60 days during the intervention. Then, at the end of the study, the mentioned skin health indicators will be measured again. Yes - There is a plan to make this available What will be shared: The data will be provided to researchers after analysis and summarization When: Starting access to results after publication To whom: Academic researchers Conditions: There are no restrictions on the use of data Where to obtain: They should contact with email address: f.javanmardy@gmail.com How to obtain: There is no time limitation Comments:
public Fardin Javanmardi
Qods Town( the West ), Shahid Farahzadi Blvd., Shahid Hafezi St
Tehran Iran (Islamic Republic of) 1981619573 +98 21 6688 0696 f.javanmardy@gmail.com Shahid Beheshti University of Medical Sciences scientific Fardin Javanmardi
National Nutrition and Food Technology Research Institute (NNFTRI), West Arghavan St. Farahzadi Blvd., Sharake Qods, Tehran, Iran
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 f.javanmardy@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age range 20-60 years Lack of any allergies Desire to include the study Do not take supplements at 6 months ago 20 years 60 years Female Suffering from any chronic disease Having any allergies (food or non-food) People with digestive problems Prevention Prevention Intervention group: In this group, on the first day, skin health indicators such as moisture, pH, elasticity, pigment and water loss through the epidermis will be measured. Then, the participants will be trained which dissolve 1 sachet containing collagen, ornithine and probiotic compounds in 200 ml of milk or water daily and eat it as a snack. One sachet will be consumed daily for 60 days during the intervention. Then, at the end of the study, the mentioned skin health indicators will be measured again. Control group: In this group, on the first day, skin health indicators such as moisture, pH, elasticity, pigment and water loss through the epidermis will be measured. Then, the participants will be trained which dissolve 1 sachet of maltodextrin compounds (22 g) in 200 ml of milk or water daily and eat it as a snack. One sachet will be consumed daily for 60 days during the intervention. Then, at the end of the study, the mentioned skin health indicators will be measured again. Skin PH. Timepoint: Before and after 60 days intervention. Method of measurement: PH meter. Elasticity. Timepoint: Before and after 60 days of the intervention. Method of measurement: Cotometer. Skin moisture. Timepoint: Before and after 60 days of the intervention. Method of measurement: Cornimeter. Trans-epidermal water loss. Timepoint: Before and after 60 days of intervention. Method of measurement: Tonometer. Skin pigments. Timepoint: Before and after 60 days of the intervention. Method of measurement: Mexameter. Body Mass Index. Timepoint: Before and after 60 days of intervention. Method of measurement: Scale and meter. Shahid Beheshti University of Medical Sciences Approved 2021-01-27 Ethics Committee of the Institute of Nutritional Research and Food Industry Qods Town( the West ), Shahid Farahzadi Blvd, Shahid Hafezi St Tehran Tehran Iran (Islamic Republic of)