- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07676838
Effect of Curd Cheese on Metabolic Health in Adults
The Effect of a Diet Intervention Supplemented With Curd Cheese on Anthropometric Measurements, Glycemia, and Lipidemia in Adults Applying to Darıca Healthy Life Center
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Metabolic disorders, including obesity, dyslipidemia, and type 2 diabetes mellitus, are major public health concerns worldwide. Dietary protein quality and source have been shown to play important roles in regulating glucose and lipid metabolism. Whey-derived proteins are rich in branched-chain amino acids and bioactive peptides that may enhance insulin sensitivity, promote satiety, and improve lipid profiles.
Curd cheese (lor cheese) is a traditional dairy product obtained during whey processing, characterized by its high-quality protein, low fat content, and rich calcium composition. It represents an affordable and accessible food that could be incorporated into dietary interventions targeting metabolic health improvement.
This study aims to investigate the effects of a curd cheese-supplemented diet on anthropometric parameters, glycemic control (including fasting glucose and HbA1c), and lipid profile (total cholesterol, HDL, LDL, and triglycerides) in adults attending the Darıca Healthy Life Center. Participants will follow a controlled dietary intervention with or without curd cheese for eight weeks.
The hypothesis of this study is that regular consumption of curd cheese as part of a balanced diet may improve metabolic parameters through increased protein intake, better glycemic regulation, and enhanced lipid metabolism.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
DARICA
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Kocaeli, DARICA, Турция (Туркие), 41700
- Darıca Healthy Life Center
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Individuals aged 40-64 years.
- Body Mass Index (BMI) greater than 25 kg/m².
- Individuals who voluntarily applied to the Darıca Healthy Life Center and agreed to participate in the study.
- Individuals who have had HbA1c, glucose, and lipid profile measurements within the past month, or will have these measurements taken as part of this study.
- Individuals who are able to comply with the curd cheese-supplemented dietary intervention for at least 8 weeks.
- Individuals who have signed the written informed consent form.
Exclusion Criteria:
- Individuals diagnosed with diabetes mellitus.
- Individuals with chronic diseases such as renal, hepatic, or cardiac failure.
- Individuals with lactose intolerance or allergy to milk and dairy products.
- Pregnant or lactating women.
- Individuals with restricted protein intake for any medical reason.
- Individuals who have participated in another dietary intervention program within the last 3 months.
- Individuals diagnosed with psychiatric disorders requiring regular treatment.
- Individuals with irregular lifestyles or communication difficulties that may prevent adherence to the dietary intervention.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Curd Cheese Supplemented Diet Group
Intervention Group - Arm Description: Participants in this arm follow a customized dietary plan for 8 weeks that includes daily servings of curd cheese. The diet is balanced for energy and macronutrient distribution according to individual needs. Curd cheese, as a high-quality protein and calcium source, is included to assess its specific effects on glucose and lipid parameters. This arm is designed to evaluate the unique metabolic effects of curd cheese supplementation compared to the control group. |
This intervention consists of daily consumption of 100 grams of curd cheese as part of a personalized dietary plan for 8 weeks.
Curd cheese is consumed at breakfast and integrated into the participants' regular meal plans.
The diet is balanced for total energy and macronutrient distribution according to individual nutritional needs.
All participants in this arm receive the same type and brand of curd cheese throughout the intervention period.
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|
Без вмешательства: Standard Diet Group
Participants in this arm follow a standard dietary plan for 8 weeks without curd cheese.
The diet is balanced according to individual energy and macronutrient needs.
This arm serves as a comparison group to determine the specific effects of curd cheese supplementation observed in the intervention group.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in HbA1c Levels
Временное ограничение: Baseline and after 8 weeks of intervention
|
To evaluate the effect of a curd cheese-supplemented diet on glycemic control by assessing changes in HbA1c levels from baseline to the end of the 8-week intervention.
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Baseline and after 8 weeks of intervention
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Fasting Glucose
Временное ограничение: Baseline and after 8 weeks
|
To assess short-term glycemic response by measuring fasting blood glucose at baseline and after the 8-week intervention.
|
Baseline and after 8 weeks
|
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Change in Lipid Profile
Временное ограничение: Baseline and after 8 weeks
|
To evaluate the effect of curd cheese supplementation on lipid metabolism by assessing changes in total cholesterol, LDL, HDL, and triglycerides from baseline to the end of the intervention.
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Baseline and after 8 weeks
|
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Change in Anthropometric Measures
Временное ограничение: Baseline and after 8 weeks
|
To evaluate changes in body mass index (BMI) from the start to the end of the intervention.
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Baseline and after 8 weeks
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Change in Anthropometric Measures
Временное ограничение: Baseline and after 8 weeks
|
To assess changes in body weight from baseline to the end of the intervention.
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Baseline and after 8 weeks
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Change in Anthropometric Measures
Временное ограничение: Baseline and after 8 weeks
|
To evaluate changes in body fat percentage from the beginning to the end of the intervention.
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Baseline and after 8 weeks
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Change in Anthropometric Measures
Временное ограничение: Baseline and after 8 weeks
|
To assess changes in waist circumference from the beginning to the end of the intervention.
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Baseline and after 8 weeks
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Ahmet M GÜNAL, PhD, RD, Halic University
- Директор по исследованиям: Salim YILMAZ, PhD, Acıbadem Mehmet Ali Aydınlar University
Публикации и полезные ссылки
Общие публикации
- Jakubowicz D, Froy O, Ahren B, Boaz M, Landau Z, Bar-Dayan Y, Ganz T, Barnea M, Wainstein J. Incretin, insulinotropic and glucose-lowering effects of whey protein pre-load in type 2 diabetes: a randomised clinical trial. Diabetologia. 2014 Sep;57(9):1807-11. doi: 10.1007/s00125-014-3305-x. Epub 2014 Jul 10.
- Kataoka Y, Kamijo YI, Ogawa Y, Sumiyoshi E, Nakae M, Ikegawa S, Manabe K, Morikawa M, Nagata M, Takasugi S, Masuki S, Nose H. Effects of hypervolemia by protein and glucose supplementation during aerobic training on thermal and arterial pressure regulations in hypertensive older men. J Appl Physiol (1985). 2016 Oct 1;121(4):1021-1031. doi: 10.1152/japplphysiol.00033.2016. Epub 2016 May 19.
- Vogtschmidt YD, Raben A, Faber I, de Wilde C, Lovegrove JA, Givens DI, Pfeiffer AFH, Soedamah-Muthu SS. Is protein the forgotten ingredient: Effects of higher compared to lower protein diets on cardiometabolic risk factors. A systematic review and meta-analysis of randomised controlled trials. Atherosclerosis. 2021 Jul;328:124-135. doi: 10.1016/j.atherosclerosis.2021.05.011. Epub 2021 May 26.
- Zhang M, Dong X, Huang Z, Li X, Zhao Y, Wang Y, Zhu H, Fang A, Giovannucci EL. Cheese consumption and multiple health outcomes: an umbrella review and updated meta-analysis of prospective studies. Adv Nutr. 2023 Sep;14(5):1170-1186. doi: 10.1016/j.advnut.2023.06.007. Epub 2023 Jun 15.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- OkanU-KO-3
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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