The Effect of Oral Whey Consumption on Insulin Resistance, Cortisol, Crp, Albumin Level and Healing Quality Before Total Hip Arthroplasty

NCT06307782 | Completed DMC

• 1 other identifier: 12833
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crp; Insulin Resistance; Cortisol; Hypersecretion; Albus; Lichen; Quality of Life

Keywords

whey; Total Hip Arthroplasty; inflammatory; Stress; Insulin Resistance

Outcome Measures

Primary Outcomes (5)

• Rate of C Reactive Protein

  physiological parameter, questionnaire

  24 hour

• Rate of insulin resistance

  physiological parameter, questionnaire

  24 hour

• Rate of albumen

  physiological parameter, questionnaire

  24 hour

• Rate of cortisol

  physiological parameter, questionnaire

  24 hour

• Healing Quality

  Quality of Recovery-15 scala

  24 hour

Study Arms (2)

Total Hip Arthroplasty, whey protein intake,

EXPERIMENTAL

In the ERAS (Enhanced Recovery After Surgery) protocol, preoperative oral carbohydrate intake must be at least 45 g. While preparing the whey mixture, 60 grams of whey powder will be mixed into 600ml bottled water to obtain a mixture worth 200 kcal. Whey will be prepared and given by the researcher at the bedside in room air using bottled water. In this study, by scanning the literature (13) and taking expert opinion (dietitian, anesthesiologist, orthopedic doctor), the individuals in the intervention group were given 6 hours after the surgery. It is planned to drink 600ml oral whey powder water first.

Dietary Supplement: whey protein intake before surgery

Total Hip Arthroplasty, water intake

ACTIVE COMPARATOR

600ml of water will be given 6 hours before the surgery.

Dietary Supplement: Water before surgery

Interventions

whey protein intake before surgery DIETARY_SUPPLEMENT

Total Hip Arthroplasty whey protein intake,Total Hip Arthroplasty, whey protein intake,CRP,cortisol insulin resistance

Total Hip Arthroplasty, whey protein intake,

Water before surgery DIETARY_SUPPLEMENT

Total Hip Arthroplasty water before surgery,Total Hip Arthroplasty, water intake,CRP,cortisol insulin resistance

Total Hip Arthroplasty, water intake

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals between the ages of 50-70,
• Spinal anesthesia
• Individuals with a BMI\<40,
• Individuals with ASA I, ASA II and ASA III

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

HÜMEYRA

Nevşehir, Nevşehir Province, 50000, Turkey (Türkiye)

Location

Related Publications (1)

• 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 Birleşik Devletleri'nde primer ve revizyon kalça ve diz artroplastisinin projeksiyonları. 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 geliştirilmiş iyileşme yolları. J Anesteziol Clin Pharmacol.; 35 :35-39. 4. Kehlet H(1997). Postoperatif patofizyoloji ve rehabilitasyonu kontrol etmek için multimodal yaklaşım. 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). Peyniraltı Suyu ve Peyniraltı Suyunun İçecek Sektöründe Değerlendirilme Olanakları. Çukurova Tarım Gıda Bil. Der.32(2);27-36

  BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: randomize clinical study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Model Details: randomize control trials

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: March 13, 2024
• Study Start: June 25, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 11, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)