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IRCT20171224038033N1 IRCT 2018-06-05 Shahid Beheshti University of Medical Sciences A Comparative Study on the Comparison of Current Infant formula in Iranian Market A Comparative Study on the Comparison of Current Infant formula in Iranian Market 2018-06-05 anticipated 10 Complete https://irct.ir/trial/29594 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: At the first, the participants are divided into two groups of four and a group of two randomly into a draw method, Blinding description: The participants in the study did not know the type of tested milk (between the three studied types). N/A Dental caries. Intervention 1: The first itervention is Aptamil 3 infant formula. At first, the participants are divided into two groups of four and two using simple random method and the interval of one week is considered as washout. In this way, each group randomly uses one of the products per week. Intervention is performed with 10 cc of one of the Infant formulas of Aptamil 3, NAN 3 and Bebelac 3 with one-week interval. The Aptamil 3 Infant formula is manufactured by Nutrition Company, NAN 3 made by Milupa, and Bebelac 3 is made by Nestle Corporation. The ingredients of the products studied are based on the information on the packaging, including protein, energy, casein, fat, linoleic acid, AA, DHA, carbohydrate, lactose, etc., as described in the table. In each session, the pH of the dental plaque base is measured by the testator at the site, in the area between the distal surface of the first premolar and the second mesenteric surface of the premolars, in all four quadrants of the mouth. The person tested then holds ten cubic meters of the infant formula in mouth for two minutes and then swallows. The pH of the plaque at designated sites of all four quadrants is measured at five, ten, twenty and sixty minutes after the application of the solution using Metrohm Microelectrode (Ω Metrohm Switzerland LL micro glass electrode) connected to the digital PH Meter (Swiss- Metrohm). It should be noted that the microelectrode is washed prior to the start of each test and at intervals of each reading with a solution 3 KCL model (pH = 7) calibrated with distilled water flow. Meanwhile, for disinfection of the electrode for intervals between the subjects, 2% glutaraldehyde solution is used for 20 minutes. The average pH at the time of the examination, separately the three materials tested in the all quadrants are determined. The results of the study were analyzed by Repeated measure ANOVA with a significance level of p <0.05. In evry 100gr of Apyamil 3 infant formula: Energy : 460 Kcal - Protein : 15.4 gr - Whey protein : 5.8 gr - Casein : 9.5 gr - Fat : 20.3 gr - Linoleic acid : 2693 mg - Alpha Linoleic Acid : 496 mg - carbohydrates: 52.6 g - Lactose : 50 g - Fiber : 3.8 g – Sodium : 220 mg – Potassium : 710 mg - Chlorine : 460 mg - Calcium : 640 mg - Phosphorus : 406 mg - Ratio of calcium and phosphorus : 1.6 - Magnesium : 53 mg – Iron : 7 mg - Zinc : 4.3 mg - Copper :280 μg – Iodine : 101 μg - Manganese : 52 μg - Selenium : 13 μg - Vitamin A : 447 μg - Vitamin D : 10.7 μg - Vitamin B1 : 412 μg - Vitamin B2 : 1000 μg - Vitamin B6 : 326 μg - Vitamin B12 : 1.6 μg - Biotin : 14 μg - Folic acid : 87 μg – Niacin : 3.2 mg – Pantothenic Acid : 3072 μg - Vitamin C : 66 mg - Vitamin K : 38 μg - Vitamin E : 8 mg – Cytidine : 7.4 mg – Uridine : 5.3 mg – Adenosine : 4.6 mg – Guanosine : 1.6 mg - Inosine : 3.1 mg – Taurine : 37 mg – Choline : 88 mg – Inositol : 35 mg - L-Carnitine : 9 mg. Intervention 2: The first itervention is Nan 3 infant formula.At first, the participants are divided into two groups of four and two using simple random method and the interval of one week is considered as washout. In this way, each group randomly uses one of the products per week. Intervention is performed with 10 cc of one of the Infant formulas of Aptamil 3, NAN 3 and Bebelac 3 with one-week interval. The Aptamil 3 Infant formula is manufactured by Nutrition Company, NAN 3 made by Milupa, and Bebelac 3 is made by Nestle Corporation. The ingredients of the products studied are based on the information on the packaging, including protein, energy, casein, fat, linoleic acid, AA, DHA, carbohydrate, lactose, etc., as described in the table. In each session, the pH of the dental plaque base is measured by the testator at the site, in the area between the distal surface of the first premolar and the second mesenteric surface of the premolars, in all four quadrants of the mouth. The person tested then holds ten cubic meters of the infant formula in mouth for two minutes and then swallows. The pH of the plaque at designated sites of all four quadrants is measured at five, ten, twenty and sixty minutes after the application of the solution using Metrohm Microelectrode (Ω Metrohm Switzerland LL micro glass electrode) connected to the digital PH Meter (Swiss- Metrohm). It should be noted that the microelectrode is washed prior to the start of each test and at intervals of each reading with a solution 3 KCL model (pH = 7) calibrated with distilled water flow. Meanwhile, for disinfection of the electrode for intervals between the subjects, 2% glutaraldehyde solution is used for 20 minutes. The average pH at the time of the examination, separately the three materials tested in the all quadrants are determined. The results of the study were analyzed by Repeated measure ANOVA with a significance level of p <0.05. Energy : 497 Kcal - Protein : 14.9 gr - Fat : 23.3 gr - Linoleic acid : 3.20 gr - Alpha Linoleic Acid : 400 mg - carbohydrates: 57 g - Lactose : 50 gr – Sodium :160 mg – Potassium : 520 mg - Chlorine : 340 mg - Calcium : 500 mg - Phosphorus : 350 mg - Magnesium :46 mg – Iron : 7.5 mg - Zinc : 6 mg - Copper :0.3 mg – Iodine : 115 μg - Manganese : 25 μg - Selenium : 10.5 μg - Vitamin A : 390 μg - Vitamin D : 7.25 μg - Vitamin B1 : 0.84 μg - Vitamin B2 : 1.32 mg - Vitamin B6 : 0.4 mg - Vitamin B12 : 1.1 μg - Biotin : 14.2 μg - Folic acid : 108 μg – Niacin : 3.7 mg – Pantothenic Acid :4.65 mg - Vitamin C : 60 mg - Vitamin K : 40 μg - Vitamin E : 8 mg – Choline : 70 mg – Inositol : 36 mg. Intervention 3: The first itervention is Bebelac 3 infant formula. At first, the participants are divided into two groups of four and two using simple random method and the interval of one week is considered as washout. In this way, each group randomly uses one of the products per week. Intervention is performed with 10 cc of one of the Infant formulas of Aptamil 3, NAN 3 and Bebelac 3 with one-week interval. The Aptamil 3 Infant formula is manufactured by Nutrition Company, NAN 3 made by Milupa, and Bebelac 3 is made by Nestle Corporation. The ingredients of the products studied are based on the information on the packaging, including protein, energy, casein, fat, linoleic acid, AA, DHA, carbohydrate, lactose, etc., as described in the table. In each session, the pH of the dental plaque base is measured by the testator at the site, in the area between the distal surface of the first premolar and the second mesenteric surface of the premolars, in all four quadrants of the mouth. The person tested then holds ten cubic meters of the infant formula in mouth for two minutes and then swallows. The pH of the plaque at designated sites of all four quadrants is measured at five, ten, twenty and sixty minutes after the application of the solution using Metrohm Microelectrode (Ω Metrohm Switzerland LL micro glass electrode) connected to the digital PH Meter (Swiss- Metrohm). It should be noted that the microelectrode is washed prior to the start of each test and at intervals of each reading with a solution 3 KCL model (pH = 7) calibrated with distilled water flow. Meanwhile, for disinfection of the electrode for intervals between the subjects, 2% glutaraldehyde solution is used for 20 minutes. The average pH at the time of the examination, separately the three materials tested in the all quadrants are determined. The results of the study were analyzed by Repeated measure ANOVA with a significance level of p <0.05. Energy : 456 Kcal - Protein : 15 gr - Whey protein : 6 gr - Casein : 9 gr - Fat : 19.6 gr - Linoleic acid : 2640 mg - Alpha Linoleic Acid : 489 mg - carbohydrates: 53.3 g - Lactose : 50.6 g - Fiber : 3.7 g – Sodium : 182 mg – Potassium : 730 mg - Chlorine : 536 mg - Calcium : 638 mg - Phosphorus : 410 mg - Ratio of calcium and phosphorus : 1.6 - Magnesium : 49 mg – Iron : 6.7 mg - Zinc : 4.4 mg - Copper :268 μg – Iodine : 105 μg - Manganese : 45 μg - Selenium : 13 μg - Vitamin A : 436 μg - Vitamin D : 9.5 μg - Vitamin B1 : 416 μg - Vitamin B2 : 822 μg - Vitamin B6 : 330 μg - Vitamin B12 : 1.3 μg - Biotin : 14 μg - Folic acid : 86 μg – Niacin : 3.1 mg – Pantothenic Acid : 2954 μg - Vitamin C : 61 mg - Vitamin K : 33 μg - Vitamin E : 7.6 mg – Cytidine : 7.1 mg – Uridine : 5 mg – Adenosine : 4.4 mg – Guanosine : 1.5 mg - Inosine : 2.9 mg – Taurine : 34 mg – Choline : 86 mg – Inositol : 32 mg - L-Carnitine : 9.2 mg. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Sara Bahman
7th Floor, Bldg No.2, Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Chamran highway, Tehran, Iran.
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2242 3163 sara.bahman@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Fatemeh Ahmadian
7th Floor, Bldg No.2, Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Chamran highway, Tehran, Iran.
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2217 5350 f.ahmadianb@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Complete systemic health Not taken antibiotics two weeks before starting the test No special diet Not diagnosed with Xerostomia No use of orthodontic or prosthetic appliance 20 years 30 years Both Smoking Pregnancy Diagnosed Periodontal disease Active dental caries Tooth filling in the examined area Prevention Prevention Prevention The first itervention is Aptamil 3 infant formula. At first, the participants are divided into two groups of four and two using simple random method and the interval of one week is considered as washout. In this way, each group randomly uses one of the products per week. Intervention is performed with 10 cc of one of the Infant formulas of Aptamil 3, NAN 3 and Bebelac 3 with one-week interval. The Aptamil 3 Infant formula is manufactured by Nutrition Company, NAN 3 made by Milupa, and Bebelac 3 is made by Nestle Corporation. The ingredients of the products studied are based on the information on the packaging, including protein, energy, casein, fat, linoleic acid, AA, DHA, carbohydrate, lactose, etc., as described in the table. In each session, the pH of the dental plaque base is measured by the testator at the site, in the area between the distal surface of the first premolar and the second mesenteric surface of the premolars, in all four quadrants of the mouth. The person tested then holds ten cubic meters of the infant formula in mouth for two minutes and then swallows. The pH of the plaque at designated sites of all four quadrants is measured at five, ten, twenty and sixty minutes after the application of the solution using Metrohm Microelectrode (Ω Metrohm Switzerland LL micro glass electrode) connected to the digital PH Meter (Swiss- Metrohm). It should be noted that the microelectrode is washed prior to the start of each test and at intervals of each reading with a solution 3 KCL model (pH = 7) calibrated with distilled water flow. Meanwhile, for disinfection of the electrode for intervals between the subjects, 2% glutaraldehyde solution is used for 20 minutes. The average pH at the time of the examination, separately the three materials tested in the all quadrants are determined. The results of the study were analyzed by Repeated measure ANOVA with a significance level of p <0.05. In evry 100gr of Apyamil 3 infant formula: Energy : 460 Kcal - Protein : 15.4 gr - Whey protein : 5.8 gr - Casein : 9.5 gr - Fat : 20.3 gr - Linoleic acid : 2693 mg - Alpha Linoleic Acid : 496 mg - carbohydrates: 52.6 g - Lactose : 50 g - Fiber : 3.8 g – Sodium : 220 mg – Potassium : 710 mg - Chlorine : 460 mg - Calcium : 640 mg - Phosphorus : 406 mg - Ratio of calcium and phosphorus : 1.6 - Magnesium : 53 mg – Iron : 7 mg - Zinc : 4.3 mg - Copper :280 μg – Iodine : 101 μg - Manganese : 52 μg - Selenium : 13 μg - Vitamin A : 447 μg - Vitamin D : 10.7 μg - Vitamin B1 : 412 μg - Vitamin B2 : 1000 μg - Vitamin B6 : 326 μg - Vitamin B12 : 1.6 μg - Biotin : 14 μg - Folic acid : 87 μg – Niacin : 3.2 mg – Pantothenic Acid : 3072 μg - Vitamin C : 66 mg - Vitamin K : 38 μg - Vitamin E : 8 mg – Cytidine : 7.4 mg – Uridine : 5.3 mg – Adenosine : 4.6 mg – Guanosine : 1.6 mg - Inosine : 3.1 mg – Taurine : 37 mg – Choline : 88 mg – Inositol : 35 mg - L-Carnitine : 9 mg The first itervention is Nan 3 infant formula.At first, the participants are divided into two groups of four and two using simple random method and the interval of one week is considered as washout. In this way, each group randomly uses one of the products per week. Intervention is performed with 10 cc of one of the Infant formulas of Aptamil 3, NAN 3 and Bebelac 3 with one-week interval. The Aptamil 3 Infant formula is manufactured by Nutrition Company, NAN 3 made by Milupa, and Bebelac 3 is made by Nestle Corporation. The ingredients of the products studied are based on the information on the packaging, including protein, energy, casein, fat, linoleic acid, AA, DHA, carbohydrate, lactose, etc., as described in the table. In each session, the pH of the dental plaque base is measured by the testator at the site, in the area between the distal surface of the first premolar and the second mesenteric surface of the premolars, in all four quadrants of the mouth. The person tested then holds ten cubic meters of the infant formula in mouth for two minutes and then swallows. The pH of the plaque at designated sites of all four quadrants is measured at five, ten, twenty and sixty minutes after the application of the solution using Metrohm Microelectrode (Ω Metrohm Switzerland LL micro glass electrode) connected to the digital PH Meter (Swiss- Metrohm). It should be noted that the microelectrode is washed prior to the start of each test and at intervals of each reading with a solution 3 KCL model (pH = 7) calibrated with distilled water flow. Meanwhile, for disinfection of the electrode for intervals between the subjects, 2% glutaraldehyde solution is used for 20 minutes. The average pH at the time of the examination, separately the three materials tested in the all quadrants are determined. The results of the study were analyzed by Repeated measure ANOVA with a significance level of p <0.05. Energy : 497 Kcal - Protein : 14.9 gr - Fat : 23.3 gr - Linoleic acid : 3.20 gr - Alpha Linoleic Acid : 400 mg - carbohydrates: 57 g - Lactose : 50 gr – Sodium :160 mg – Potassium : 520 mg - Chlorine : 340 mg - Calcium : 500 mg - Phosphorus : 350 mg - Magnesium :46 mg – Iron : 7.5 mg - Zinc : 6 mg - Copper :0.3 mg – Iodine : 115 μg - Manganese : 25 μg - Selenium : 10.5 μg - Vitamin A : 390 μg - Vitamin D : 7.25 μg - Vitamin B1 : 0.84 μg - Vitamin B2 : 1.32 mg - Vitamin B6 : 0.4 mg - Vitamin B12 : 1.1 μg - Biotin : 14.2 μg - Folic acid : 108 μg – Niacin : 3.7 mg – Pantothenic Acid :4.65 mg - Vitamin C : 60 mg - Vitamin K : 40 μg - Vitamin E : 8 mg – Choline : 70 mg – Inositol : 36 mg The first itervention is Bebelac 3 infant formula. At first, the participants are divided into two groups of four and two using simple random method and the interval of one week is considered as washout. In this way, each group randomly uses one of the products per week. Intervention is performed with 10 cc of one of the Infant formulas of Aptamil 3, NAN 3 and Bebelac 3 with one-week interval. The Aptamil 3 Infant formula is manufactured by Nutrition Company, NAN 3 made by Milupa, and Bebelac 3 is made by Nestle Corporation. The ingredients of the products studied are based on the information on the packaging, including protein, energy, casein, fat, linoleic acid, AA, DHA, carbohydrate, lactose, etc., as described in the table. In each session, the pH of the dental plaque base is measured by the testator at the site, in the area between the distal surface of the first premolar and the second mesenteric surface of the premolars, in all four quadrants of the mouth. The person tested then holds ten cubic meters of the infant formula in mouth for two minutes and then swallows. The pH of the plaque at designated sites of all four quadrants is measured at five, ten, twenty and sixty minutes after the application of the solution using Metrohm Microelectrode (Ω Metrohm Switzerland LL micro glass electrode) connected to the digital PH Meter (Swiss- Metrohm). It should be noted that the microelectrode is washed prior to the start of each test and at intervals of each reading with a solution 3 KCL model (pH = 7) calibrated with distilled water flow. Meanwhile, for disinfection of the electrode for intervals between the subjects, 2% glutaraldehyde solution is used for 20 minutes. The average pH at the time of the examination, separately the three materials tested in the all quadrants are determined. The results of the study were analyzed by Repeated measure ANOVA with a significance level of p <0.05. Energy : 456 Kcal - Protein : 15 gr - Whey protein : 6 gr - Casein : 9 gr - Fat : 19.6 gr - Linoleic acid : 2640 mg - Alpha Linoleic Acid : 489 mg - carbohydrates: 53.3 g - Lactose : 50.6 g - Fiber : 3.7 g – Sodium : 182 mg – Potassium : 730 mg - Chlorine : 536 mg - Calcium : 638 mg - Phosphorus : 410 mg - Ratio of calcium and phosphorus : 1.6 - Magnesium : 49 mg – Iron : 6.7 mg - Zinc : 4.4 mg - Copper :268 μg – Iodine : 105 μg - Manganese : 45 μg - Selenium : 13 μg - Vitamin A : 436 μg - Vitamin D : 9.5 μg - Vitamin B1 : 416 μg - Vitamin B2 : 822 μg - Vitamin B6 : 330 μg - Vitamin B12 : 1.3 μg - Biotin : 14 μg - Folic acid : 86 μg – Niacin : 3.1 mg – Pantothenic Acid : 2954 μg - Vitamin C : 61 mg - Vitamin K : 33 μg - Vitamin E : 7.6 mg – Cytidine : 7.1 mg – Uridine : 5 mg – Adenosine : 4.4 mg – Guanosine : 1.5 mg - Inosine : 2.9 mg – Taurine : 34 mg – Choline : 86 mg – Inositol : 32 mg - L-Carnitine : 9.2 mg Dental plaque pH. Timepoint: Before intervention and at intervals of 5-10-20-60 minutes after intervention. Method of measurement: Dental plaque pH - Microelectrode. Shahid Beheshti University of Medical Sciences Approved 2017-10-17 Ethics committee of Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2, Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Chamran highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)