- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
DARICA
-
Kocaeli, DARICA, Turkey (Türkiye), 41700
- Darıca Healthy Life Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in HbA1c Levels
Time Frame: 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.
|
Baseline and after 8 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Fasting Glucose
Time Frame: 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
|
|
Change in Lipid Profile
Time Frame: 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.
|
Baseline and after 8 weeks
|
|
Change in Anthropometric Measures
Time Frame: Baseline and after 8 weeks
|
To evaluate changes in body mass index (BMI) from the start to the end of the intervention.
|
Baseline and after 8 weeks
|
|
Change in Anthropometric Measures
Time Frame: Baseline and after 8 weeks
|
To assess changes in body weight from baseline to the end of the intervention.
|
Baseline and after 8 weeks
|
|
Change in Anthropometric Measures
Time Frame: Baseline and after 8 weeks
|
To evaluate changes in body fat percentage from the beginning to the end of the intervention.
|
Baseline and after 8 weeks
|
|
Change in Anthropometric Measures
Time Frame: Baseline and after 8 weeks
|
To assess changes in waist circumference from the beginning to the end of the intervention.
|
Baseline and after 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ahmet M GÜNAL, PhD, RD, Haliç University
- Study Director: Salim YILMAZ, PhD, Acıbadem Mehmet Ali Aydınlar University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OkanU-KO-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabete Mellitus
-
SeraxisNot yet recruitingDiabete Mellitus | Diabete Type 1
-
Rio Grande do Sul State Health Department - SES/RSAgnes Nogueira Gossenheimer; Ana Paula Rigo; Roberto Eduardo SchneidersNot yet recruitingTelemedicine | Diabete Mellitus | Diabete Type 2 | TelehealthBrazil
-
Medanta, The Medicity, IndiaCompletedDiabete Mellitus | Diabete Type 2 | Hyperglycaemia (Diabetic)India
-
Assiut UniversityNot yet recruiting
-
King Abdulaziz UniversityEnrolling by invitation
-
Dong-A ST Co., Ltd.Not yet recruiting
-
Bahria UniversityCompleted
-
Hospices Civils de LyonCompletedDiabete Type 2 | Diabete Type 1France
-
Ain Shams UniversityNot yet recruiting
-
Bahir Dar UniversityNot yet recruitingDiabete Mellitus | Diabetes Knowledge Score
Clinical Trials on Curd Cheese Supplemented Diet
-
University of MinnesotaNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Vascular Diseases | Hypertension
-
UCSF Benioff Children's Hospital OaklandAlmond Board of CaliforniaCompletedDyslipidemia | Obesity, AbdominalUnited States
-
Laval UniversityDairy Farmers of Canada; Agriculture and Agri-Food CanadaCompleted
-
Laval UniversityDairy Farmers of Canada; Agriculture and Agri-Food CanadaCompleted
-
Fresenius KabiCompletedChronic Kidney DiseaseHungary
-
Fresenius KabiCompletedChronic Kidney DiseaseChina
-
Pronacera Therapeutics SLCentre for the Development of Industrial Technology, SpainActive, not recruiting
-
Laval UniversityDairy Farmers of CanadaCompletedCardiovascular Diseases | HypertensionCanada
-
Fresenius KabiCompletedChronic Kidney DiseaseRussian Federation
-
University of Alabama at BirminghamCompletedCardiovascular Diseases | Metabolic Syndrome | Insulin SensitivityUnited States