Quality of Life Clinical Trial
— WHEY THAOfficial title:
The Effect of Oral Whey Consumption on Insulin Resistance, Cortisol, Crp, Albumin Level
Verified date | March 2024 |
Source | TC Erciyes University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Purpose: It was planned to determine the effect of oral whey given before total hip arthroplasty (THA) on postoperative insulin resistance, cortisol, CRP((C reactive protein), albumin level and healing quality. Design: It was planned as Randomized Controlled. Method: Research: The study is planned to include individuals aged 50-70, who are planned for THA in the orthopedics and traumatology clinic of a public hospital, who have undergone spinal anesthesia, who have BMI <40 and ASA (American Society of Anesthesiologists)1,2,3. Individuals with endocrine or renal disorders or allergies to whey will be excluded from the study. It was planned to include at least 60 patients in the study (30 in the intervention group, 30 in the control group). It is planned to use the Patient Introduction Information Form, Physiological Measurements Chart (vital findings (blood pressure, pulse, respiratory SpO2 (pulse oximetry) value), blood glucose, cortisol, CRP and albumin value and insulin resistance) and postoperative recovery quality scale in data collection. The intervention group will be given 600 ml of oral whey 6 hours before the surgery, and the control group will be allowed to drink 600 ml of drinking water 6 hours before the surgery. 3ml of blood will be taken for blood glucose, CRP, cortisol, albumin and insulin resistance values 24 hours before the surgery, just before entering the surgery and 24 hours after the surgery. The first part of the healing quality scale is planned to be evaluated immediately before the surgery, and the second part 24 hours after the surgery. Conclusion: When the literature was scanned, it was seen that the number of studies examining the effect of oral whey on metabolic and endocrine values in orthopedic patients was very limited and academic studies were needed. In this context, examining the effect of whey intake given before THA on the patient's blood glucose, CRP, albumin, cortisol, insulin resistance and healing quality is an original research that will contribute to the field.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 70 Years |
Eligibility | Inclusion Criteria: - Individuals between the ages of 50-70, - Spinal anesthesia - Individuals with a BMI<40, - Individuals with ASA I, ASA II and ASA III Exclusion Criteria: - Patients with communication problems - Individuals with hepatic, renal, endocrine, gastric and neurological disorders - Any diagnosed psychiatric disease, - NRS (nutritional risk score )2002 score 3 Individuals with malnutrition and above, - Allergy to whey and lactose intolerance will be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | HÜMEYRA | Nevsehir | Nevsehi?r |
Lead Sponsor | Collaborator |
---|---|
TC Erciyes University |
Turkey,
1.Ferguson R, Palmer A, Taylor A, Porter M, Malchau H, Jones S,G(2018). Hip replacement. Lancet.392(10158):1662-1671 2.Kurtz S, Ong K, Lau E, Mowat F, Halpern M(2007). 2005'ten 2030'a kadar Amerika Birlesik Devletleri'nde primer ve revizyon kalça ve diz artroplastisinin projeksiyonlari. J Bone Joint Surg Am; 89 :780-785. 3. Kaye A, Urman R, Cornett E, Hart B, Chami A, Gayle J, et al(2019). Ortopedik cerrahide gelistirilmis iyilesme yollari. J Anesteziol Clin Pharmacol.; 35 :35-39. 4. Kehlet H(1997). Postoperatif patofizyoloji ve rehabilitasyonu kontrol etmek için multimodal yaklasim. Br J Anaesth.; 78 :606-617. 5.Nygren J (2006). The metabolic effects of fasting and surgery. Best Practice & Research Clinical Anaesthesiology.20(3):429-438 6. Luhovyy BL, Akhavan T, Anderson GH. Whey proteins in the regulation of food intake and satiety. J Am Coll Nutr. 2007;26(6):704S-12S. doi:10.1080/07315724.2007.10719651 7. Zemel MB. Mechanisms of dairy modulation of adiposity. J. Nutr.2003;133:252S-256S 8. Perrone F, da-Silva-Filho AC, Adôrno IF, Anabuki NT, LealFS, Colombo T, da Silva BD, Dock-Nascimento DB, Damiao A, da Aguilar-Nascimento JE(2011). Effects ofpreoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance. A randomized trial. Nutr J.;10:66. 9. Singh M, Chaudhary M, Vashistha A, Kaur G (2015). Evaluation of effects of a preoperative 2-hour fast with glutamine and carbohydrate rich drink on insulin resistance in maxillofacial surgery. J Oral Biol Craniofac Res.5(1):34-9 10. Güzeler N, Esmek E,M, & Kalender M (2017). Peyniralti Suyu ve Peyniralti Suyunun Içecek Sektöründe Degerlendirilme Olanaklari. Çukurova Tarim Gida Bil. Der.32(2);27-36
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of C Reactive Protein | physiological parameter, questionnaire | 24 hour | |
Primary | Rate of insulin resistance | physiological parameter, questionnaire | 24 hour | |
Primary | Rate of albumen | physiological parameter, questionnaire | 24 hour | |
Primary | Rate of cortisol | physiological parameter, questionnaire | 24 hour | |
Primary | Healing Quality | Quality of Recovery-15 scala | 24 hour |
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