Elective Hip Fracture SurgeryNCT06316648
Whey Intake Blood Glucose, Fasting, Thirst, Nausea and Vomiting Levels of Patients Undergoing Elective Hip Fracture Surgery
A study testing whey intake group in people with Elective Hip Fracture Surgery, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Whey Intake Blood Glucose, Fasting, Thirst, Nausea, Vomiting Elective Hip Fracture Surgery Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elective Hip Fracture Surgery
- What is being tested?
- whey intake group
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2021to 20 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years of age or older,
- Belonging to ASA II or III group,
- Having HA surgery for the first time, and
- Having the surgery performed under spinal anesthesia.
Who cannot join
- Diabetes Mellitus,
- Undergoing emergency surgery,
- Having gastrointestinal and endocrine problems,
- Using medications that may affect blood sugar,
- Patients with psychiatric/neurological disorders, patients who need any fluid or blood in the preoperative period, whey allergy, and patients who have intensive care in the postoperative period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Oral Whey Intake on Blood Glucose, Fasting, Thirst, Nausea and Vomiting Levels of Patients Undergoing Elective Hip Fracture Surgery: A Randomized Controlled Study
Whey Intake Blood Glucose, Fasting, Thirst, Nausea, Vomiting Elective Hip Fracture Surgery
Read the detailed description
The prolonged fasting period before surgery causes symptoms such as anxiety, hypoglycemia, increase in gastric volume, decrease in pH value, development of insulin resistance, thirst, feeling of hunger, hypovolemia, dehydration, headache, etc. in patients. For these reasons,Guidelines for Preoperative Nutrition in Children and Adults prepared by the European Society of Anesthesiologists, it was stated that solid foods six hours before surgery and clear liquids two hours before surgery could be consumed.In the accelerated recovery protocol (Enhanced Recovery After Surgery- ERAS), the preoperative fasting period before anesthesia is stated as two hours for liquid foods and six hours for solid foods (high level of evidence, strong level of recommendation).
Carbohydrate drinks act as a main meal in patients, increasing satiety and reducing insulin resistance. Carbohydrate drinks also increase the feeling of thirst and help to improve thirst sensitization. Therefore, it is recommended that patients should drink them before surgery. Carbohydrate-rich liquids that can be drunk up to two hours before elective surgery reduce fasting, thirst and postoperative insulin resistance and make the person feel good (evidence level 1++, recommendation grade A).
Hip fracture is a problem that increases with advanced age. It seems likely that the encounter with this problem and its costs will increase in the world due to the prolongation of life expectancy. Furthermore, the increased risk of osteoporosis due to increased sedentary life and malnutrition contribute to the development of this problem.Surgery is required in the treatment of 98% of elderly patients with hip fractures. Besides, the presence of chronic diseases in most elderly patients increases the risk of mortality and morbidity. Therefore, the risk of perioperative complications in elderly patients with hip fractures is a serious clinical problem.
Whey is a translucent, greenish-yellow liquid protein source obtained from the precipitation of casein in cheese or casein production. Similar in composition to milk, whey contains about half of the milk dry matter, almost all of the milk sugar, about 1/5 of the proteins and most of the B vitamins. After technological developments, whey is no longer considered as a waste but is used in industry. Many clinical trials have shown that whey is effective in the treatment of cancer, AIDS, hepatitis B, heart diseases and osteoporosis. 6 Prolonged preoperative fasting in elderly patients causes metabolic changes, and postoperative nausea and vomiting cause changes in blood glucose and prolonged hospital stay. When the literature was reviewed, it was observed that the number of studies on whey in preoperative oral carbohydrate intake, which is included in ERAS protocols in orthopedic patients, is very limited and academic studies are needed. This study was conducted to determine the effect of whey, as a different liquid other than oral carbohydrate liquids, on patients hunger, thirst, blood sugar and nausea and vomiting.
- Conditions
- Elective Hip Fracture Surgery
- Being tested
- whey intake group, control group
- Keywords
- Whey,, Fasting, Thirsts, Nausea, Vomiting
- Medical subject headings
- Fasting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey intake groupDietary supplement
It was prepared at the bedside by the first investigator for the patients in the oral whey intervention group by mixing 54 grams of 70% demineralized whey powder taken from the herbalist into 600 ml of drinking water six hours before the surgery, and the patients were given 400 ml six hours before the surgery and 200 ml two hours before the surgery. They were given ml and allowed to drink.
control groupProcedure or surgery
The patients were left fasting after 00:00.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | At 00:00 the night before the surgery, the researcher told the patients in the control group that they could have fruit juice/water if they wanted and waited for 10 minutes. The researcher then initiated the restriction process by informing the patients that they could no longer have food/water. Fasting, thirst, blood glucose and nausea-vomiting evaluations applied to the patients in the intervention group were also performed on the patients in the control group at the same hours. IV fluid therapy was not administered to both groups before surgical intervention. Receives: Procedure: control group |
| whey intake | Experimental | Since whey powder contains 73.45 grams of carbohydrate per 100 grams, whey was given to the patients in this study, unlike OCS (Oral Carbohydrate Solution), as it met the requirement in the ERAS protocol that at least 45 g of oral carbohydrate solution can be given two hours before surgery. It was prepared at the bedside by the first investigator for the patients in the oral whey intervention group by mixing 54 grams of 70% demineralized whey powder taken from the herbalist into 600 ml of drinking water six hours before the surgery, and the patients were given 400 ml six hours before the surgery and 200 ml two hours before the surgery. They were given ml and allowed to drink. Before the surgery, the patients' hunger, thirst, blood glucose and nausea and vomiting levels were evaluated. Receives: Dietary Supplement: whey intake group |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose
The value was measured with 1ml of blood from the patient's fingertip.
Measured: 12 week
Secondary outcomes (2)
Fasting, Thirst
Hunger and thirst status was evaluated with VAS.VAS is a scale with different names at both ends on a 10 cm long vertical or horizontal line (0 = no hunger - no thirst, 10 = most severe hunger - thirst
Measured: 12 week
Nausea and Vomiting
The Postoperative Nausea And Vomiting Impact Scale was used.A score of five or more from the scale indicates "clinically significant nausea and vomiting".
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start20 Apr 2021
- Primary completion20 Apr 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Elective Hip Fracture SurgeryStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multidisciplinary cooperation was performed for the effective and efficient conduct of the study. In determining the patients to administer Whey according to the study's inclusion criteria, an orthopedic and traumatological specialist's support was received, as well as that of an anesthesiologist. On the other hand, the researcher cooperated with a nutritionist in preparing and assessing the Whey content to be administered to the patients.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HÜMEYRA YÜKSEL, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316648
- Sponsor's protocol ID
- 210366
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Njoroge G, Kivuti-Bitok L, Kimani S. Preoperative Fasting among Adult Patients for Elective Surgery in a Kenyan Referral Hospital. Int Sch Res Notices. 2017 Apr 12;2017:2159606. doi: 10.1155/2017/2159606. eCollection 2017.
PubMed 284878773. Özyürek P. Hastanın sıvı yönetimi. Turkiye Klinikleri Journal of Surgical Nursing- Special Topics 2016:2(2);24- 32.
Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
PubMed 2171271631. Ayoğlu, H, Uçan, B, Taşçılar, Ö, Atik, L, Kaptan Macit, Y, Turan Özkoçak, I(2009). Preoperatif oral karbonhidrat solüsyonu kullanılmasının hasta anksiyetesi ve konforu üzerine etkileri. TARD,37(6), 374-82.
Noblett SE, Watson DS, Huong H, Davison B, Hainsworth PJ, Horgan AF. Pre-operative oral carbohydrate loading in colorectal surgery: a randomized controlled trial. Colorectal Dis. 2006 Sep;8(7):563-9. doi: 10.1111/j.1463-1318.2006.00965.x.
PubMed 16919107Deng Y, Fang Y, Li H, Chen J, An J, Qiao S, Wang C. A preoperative whey protein and glucose drink before hip fracture surgery in the aged improves symptomatic and metabolic recovery. Asia Pac J Clin Nutr. 2020;29(2):234-238. doi: 10.6133/apjcn.202007_29(2).0004.
PubMed 326742296. Güzeler N. Esmek E. Kalender M. Peyniraltı Suyu Ve Peyniraltı Suyunun İçecek Sektöründe Değerlendirilme Olanakları. Çukurova Tarım Ve Gıda Bilimleri Dergisi.2017:32(2); 27-36
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Oral Whey Intake on Blood Glucose, Fasting, Thirst, Nausea and Vomiting Levels of Patients Undergoing Elective Hip Fracture Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06316648
- Acronym / sponsor ID
- 210366
- Conditions
- Elective Hip Fracture Surgery
- Keywords
- Whey,, Fasting, Thirsts, Nausea, Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Whey Intake Blood Glucose, Fasting, Thirst, Nausea, Vomiting Elective Hip Fracture Surgery
Detailed description
The prolonged fasting period before surgery causes symptoms such as anxiety, hypoglycemia, increase in gastric volume, decrease in pH value, development of insulin resistance, thirst, feeling of hunger, hypovolemia, dehydration, headache, etc. in patients. For these reasons,Guidelines for Preoperative Nutrition in Children and Adults prepared by the European Society of Anesthesiologists, it was stated that solid foods six hours before surgery and clear liquids two hours before surgery could be consumed.In the accelerated recovery protocol (Enhanced Recovery After Surgery- ERAS), the preoperative fasting period before anesthesia is stated as two hours for liquid foods and six hours for solid foods (high level of evidence, strong level of recommendation).
Carbohydrate drinks act as a main meal in patients, increasing satiety and reducing insulin resistance. Carbohydrate drinks also increase the feeling of thirst and help to improve thirst sensitization. Therefore, it is recommended that patients should drink them before surgery. Carbohydrate-rich liquids that can be drunk up to two hours before elective surgery reduce fasting, thirst and postoperative insulin resistance and make the person feel good (evidence level 1++, recommendation grade A).
Hip fracture is a problem that increases with advanced age. It seems likely that the encounter with this problem and its costs will increase in the world due to the prolongation of life expectancy. Furthermore, the increased risk of osteoporosis due to increased sedentary life and malnutrition contribute to the development of this problem.Surgery is required in the treatment of 98% of elderly patients with hip fractures. Besides, the presence of chronic diseases in most elderly patients increases the risk of mortality and morbidity. Therefore, the risk of perioperative complications in elderly patients with hip fractures is a serious clinical problem.
Whey is a translucent, greenish-yellow liquid protein source obtained from the precipitation of casein in cheese or casein production. Similar in composition to milk, whey contains about half of the milk dry matter, almost all of the milk sugar, about 1/5 of the proteins and most of the B vitamins. After technological developments, whey is no longer considered as a waste but is used in industry. Many clinical trials have shown that whey is effective in the treatment of cancer, AIDS, hepatitis B, heart diseases and osteoporosis. 6 Prolonged preoperative fasting in elderly patients causes metabolic changes, and postoperative nausea and vomiting cause changes in blood glucose and prolonged hospital stay. When the literature was reviewed, it was observed that the number of studies on whey in preoperative oral carbohydrate intake, which is included in ERAS protocols in orthopedic patients, is very limited and academic studies are needed. This study was conducted to determine the effect of whey, as a different liquid other than oral carbohydrate liquids, on patients hunger, thirst, blood sugar and nausea and vomiting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multidisciplinary cooperation was performed for the effective and efficient conduct of the study. In determining the patients to administer Whey according to the study's inclusion criteria, an orthopedic and traumatological specialist's support was received, as well as that of an anesthesiologist. On the other hand, the researcher cooperated with a nutritionist in preparing and assessing the Whey content to be administered to the patients.
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: control groupAt 00:00 the night before the surgery, the researcher told the patients in the control group that they could have fruit juice/water if they wanted and waited for 10 minutes. The researcher then initiated the restriction process by informing the patients that they could no longer have food/water. Fasting, thirst, blood glucose and nausea-vomiting evaluations applied to the patients in the intervention group were also performed on the patients in the control group at the same hours. IV fluid therapy was not administered to both groups before surgical intervention. |
| whey intake | Experimental | Dietary Supplement: whey intake groupSince whey powder contains 73.45 grams of carbohydrate per 100 grams, whey was given to the patients in this study, unlike OCS (Oral Carbohydrate Solution), as it met the requirement in the ERAS protocol that at least 45 g of oral carbohydrate solution can be given two hours before surgery. It was prepared at the bedside by the first investigator for the patients in the oral whey intervention group by mixing 54 grams of 70% demineralized whey powder taken from the herbalist into 600 ml of drinking water six hours before the surgery, and the patients were given 400 ml six hours before the surgery and 200 ml two hours before the surgery. They were given ml and allowed to drink. Before the surgery, the patients' hunger, thirst, blood glucose and nausea and vomiting levels were evaluated. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60 years of age or older,
- Belonging to ASA II or III group,
- Having HA surgery for the first time, and
- Having the surgery performed under spinal anesthesia.
Key exclusion criteria (5 listed)
- Diabetes Mellitus,
- Undergoing emergency surgery,
- Having gastrointestinal and endocrine problems,
- Using medications that may affect blood sugar,
- Patients with psychiatric/neurological disorders, patients who need any fluid or blood in the preoperative period, whey allergy, and patients who have intensive care in the postoperative period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whey intake groupIt was prepared at the bedside by the first investigator for the patients in the oral whey intervention group by mixing 54 grams of 70% demineralized whey powder taken from the herbalist into 600 ml of drinking water six hours before the surgery, and the patients were given 400 ml six hours before the surgery and 200 ml two hours before the surgery. They were given ml and allowed to drink. | Dietary supplement | whey intake |
| control groupThe patients were left fasting after 00:00. | Procedure or surgery | control group |
Primary outcome
blood glucose
Time frame: 12 week
The value was measured with 1ml of blood from the patient's fingertip.
2 secondary outcomes
Fasting, Thirst
Time frame: 12 week
Nausea and Vomiting
Time frame: 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Results publication: PubMed 28487877Njoroge G, Kivuti-Bitok L, Kimani S. Preoperative Fasting among Adult Patients for Elective Surgery in a Kenyan Referral Hospital. Int Sch Res Notices. 2017 Apr 12;2017:2159606. doi: 10.1155/2017/2159606. eCollection 2017.
- Results publication3. Özyürek P. Hastanın sıvı yönetimi. Turkiye Klinikleri Journal of Surgical Nursing- Special Topics 2016:2(2);24- 32.
- Results publication: PubMed 21712716Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
- Results publication31. Ayoğlu, H, Uçan, B, Taşçılar, Ö, Atik, L, Kaptan Macit, Y, Turan Özkoçak, I(2009). Preoperatif oral karbonhidrat solüsyonu kullanılmasının hasta anksiyetesi ve konforu üzerine etkileri. TARD,37(6), 374-82.
- Results publication: PubMed 16919107Noblett SE, Watson DS, Huong H, Davison B, Hainsworth PJ, Horgan AF. Pre-operative oral carbohydrate loading in colorectal surgery: a randomized controlled trial. Colorectal Dis. 2006 Sep;8(7):563-9. doi: 10.1111/j.1463-1318.2006.00965.x.
- Results publication: PubMed 32674229Deng Y, Fang Y, Li H, Chen J, An J, Qiao S, Wang C. A preoperative whey protein and glucose drink before hip fracture surgery in the aged improves symptomatic and metabolic recovery. Asia Pac J Clin Nutr. 2020;29(2):234-238. doi: 10.6133/apjcn.202007_29(2).0004.
- Results publication6. Güzeler N. Esmek E. Kalender M. Peyniraltı Suyu Ve Peyniraltı Suyunun İçecek Sektöründe Değerlendirilme Olanakları. Çukurova Tarım Ve Gıda Bilimleri Dergisi.2017:32(2); 27-36
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whey intake group in people with Elective Hip Fracture Surgery, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood glucose (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06316648, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.