]>
IRCT20210427051104N1 IRCT 2021-06-26 Alborz University of Medical Sciences Evaluation of the effectiveness of low protein and low phenylalanine products (Zarmacaron) in the diet of people with phenylketonuria Comparison of the effect of low protein pasta with regular pasta on blood phenylalanine levels in children with phenylketonuria 2021-07-23 anticipated 30 Complete https://irct.ir/trial/56487 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: Individuals are divided into two groups by the randomized block method. The blocks will be selected in six and random numbers will be generated by Excel software to select the blocks. N/A phenylketonuria. Intervention 1: Intervention group: first receives the standard diet with low phenylalanine pasta and then the standard diet without diet products ---The first group uses the standard phenylketonuria diet with low phenylalanine pasta for one week. Then for a week all patients will be free to choose daily food (rest period similar to normal pre-study diet). Next, participants use a standard diet without diet cereal products for a week. It should be noted that all diets are designed equally in terms of the amount of phenylalanine. Therefore, the duration of the intervention will be 3 weeks. All patients are evaluated for food intake and blood phenylalanine levels at the beginning of the study, at the end of the first week, at the end of the second week, at the end of the study. Tests for patients include: evaluation of body composition using body analyzer, evaluation of food intake using a food record questionnaire, and blood tests, including serum phenylalanine level, which is performed 4 times per patient. Other biochemical indicators that are tested only at the beginning of the study to assess the nutritional status of patients includes: Tyr amino acid, CBC, FPG, Uric acid, Creatinine, Cholesterol, LDL, HDL, Triglyceride, Ferritin, B12, Folic acid, Homocysteine, 25-OH-VitaminD, Zinc, Prealbumin. Also, the level of satisfaction and adherence of the people to the diet in different phases is measured and scored. Intervention 2: Control group: first receives the standard diet without diet products and then the standard diet with low phenylalanine pasta--- Control group: first receives the standard diet without diet products and then the standard diet with low phenylalanine pasta---The first group uses the standard phenylketonuria diet without diet cereal products for one week. Then for a week all patients will be free to choose daily food (rest period similar to normal pre-study diet). Next, participants use a standard diet with low phenylalanine pasta for a week. It should be noted that all diets are designed equally in terms of the amount of phenylalanine. Therefore, the duration of the intervention will be 3 weeks. All patients are evaluated for food intake and blood phenylalanine levels at the beginning of the study, at the end of the first week, at the end of the second week, at the end of the study. Tests for patients include: evaluation of body composition using body analyzer, evaluation of food intake using a food record questionnaire, and blood tests, including serum phenylalanine level, which is performed 4 times per patient. Other biochemical indicators that are tested only at the beginning of the study to assess the nutritional status of patients includes: Tyr amino acid, CBC, FPG, Uric acid, Creatinine, Cholesterol, LDL, HDL, Triglyceride, Ferritin, B12, Folic acid, Homocysteine, 25-OH-VitaminD, Zinc, Prealbumin. Also, the level of satisfaction and adherence of the people to the diet in different phases is measured and scored. Yes - There is a plan to make this available What will be shared: All data can be shared. When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Decide on a case by case basis Where to obtain: Principal Investigator Dr. Hoda Derakhshanian h.derakhshanian@gmail.com How to obtain: After coordination with the principal investigator, the information will be available within one month. Comments:
public Hoda Derakhshanian
Nilufar Bldg., 1st Farhang Ave., Farhangestan Ave., West Hakim highway
Tehran Iran (Islamic Republic of) 1486757628 +98 21 4609 6094 h.derakhshanian@abzums.ac.ir Alborz University of Medical Sciences scientific Hoda Derakhshanian
Nilufar Bldg., 1st Farhang Ave., Farhangestan Ave., West Hakim highway
Tehran Iran (Islamic Republic of) 1486757628 +98 21 4609 6094 h.derakhshanian@abzums.ac.ir Alborz University of Medical Sciences Iran (Islamic Republic of) Children with phenylketonuria 1 year 18 years Both Reluctance to consume pasta Suffering from other underlying diseases Taking KUVAN drug Parents' dissatisfaction with participation in the research project E70.0 Classical phenylketonuria Lifestyle Lifestyle Intervention group: first receives the standard diet with low phenylalanine pasta and then the standard diet without diet products ---The first group uses the standard phenylketonuria diet with low phenylalanine pasta for one week. Then for a week all patients will be free to choose daily food (rest period similar to normal pre-study diet). Next, participants use a standard diet without diet cereal products for a week. It should be noted that all diets are designed equally in terms of the amount of phenylalanine. Therefore, the duration of the intervention will be 3 weeks. All patients are evaluated for food intake and blood phenylalanine levels at the beginning of the study, at the end of the first week, at the end of the second week, at the end of the study. Tests for patients include: evaluation of body composition using body analyzer, evaluation of food intake using a food record questionnaire, and blood tests, including serum phenylalanine level, which is performed 4 times per patient. Other biochemical indicators that are tested only at the beginning of the study to assess the nutritional status of patients includes: Tyr amino acid, CBC, FPG, Uric acid, Creatinine, Cholesterol, LDL, HDL, Triglyceride, Ferritin, B12, Folic acid, Homocysteine, 25-OH-VitaminD, Zinc, Prealbumin. Also, the level of satisfaction and adherence of the people to the diet in different phases is measured and scored. Control group: first receives the standard diet without diet products and then the standard diet with low phenylalanine pasta--- Control group: first receives the standard diet without diet products and then the standard diet with low phenylalanine pasta---The first group uses the standard phenylketonuria diet without diet cereal products for one week. Then for a week all patients will be free to choose daily food (rest period similar to normal pre-study diet). Next, participants use a standard diet with low phenylalanine pasta for a week. It should be noted that all diets are designed equally in terms of the amount of phenylalanine. Therefore, the duration of the intervention will be 3 weeks. All patients are evaluated for food intake and blood phenylalanine levels at the beginning of the study, at the end of the first week, at the end of the second week, at the end of the study. Tests for patients include: evaluation of body composition using body analyzer, evaluation of food intake using a food record questionnaire, and blood tests, including serum phenylalanine level, which is performed 4 times per patient. Other biochemical indicators that are tested only at the beginning of the study to assess the nutritional status of patients includes: Tyr amino acid, CBC, FPG, Uric acid, Creatinine, Cholesterol, LDL, HDL, Triglyceride, Ferritin, B12, Folic acid, Homocysteine, 25-OH-VitaminD, Zinc, Prealbumin. Also, the level of satisfaction and adherence of the people to the diet in different phases is measured and scored Phenylalanine. Timepoint: Day 0, 7, 14 and 21 of intervention. Method of measurement: High Performance Liquid Chromatography. Diet compliance and satisfaction. Timepoint: Day 0, 7, 14 and 21 of intervention. Method of measurement: Questionnaire. Body composition. Timepoint: Day 0, 7, 14 and 21 of intervention. Method of measurement: Body analyzer - Inbody270. Zarmacaron Alborz University of Medical Sciences Zarmacaron Approved 2021-03-06 Ethics committee of Alborz University of Medical Sciences Vice chancellor for research and technology, Alborz University of medical Sciences, Saffarian St., Golshahr Ave., Karaj, Alborz Karaj Alborz Iran (Islamic Republic of)