Whey ProteinNCT06607965
Whey Protein and Carbohydrates in ERAS for Recovery After Thyroidectomy: A Cohort Study
A study testing Whey Protein and Carbohydrates in people with Whey Protein and Thyroid Neoplasms, run by Chongqing General Hospital at 1 site in China.
Trial summary
Exploring the effects of whey protein combined with carbohydrates in an Enhanced Recovery After Surgery (ERAS) protocol on the postoperative recovery of thyroid cancer patients undergoing lateral neck dissection, aiming to provide more precise research and guidance for the perioperative accelerated recovery plan in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Whey Protein, Thyroid Neoplasms, Neck Dislocation
- What is being tested?
- Whey Protein and Carbohydrates
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older;
- Differentiated thyroid cancer with lateral lymph node dissection;
- Written informed consent provided by the participant.
Who cannot join
- History of chronic liver or kidney disease, ischemic heart disease, or diabetes;
- Previous neck surgery or history of iodine-131 radiation;
- Allergy to soy or whey protein;
- Intraoperative chylous leak;
- Other special types of thyroid cancer.
Trial locations and contacts
1 site in 1 country.
China1 site
Chongqing General Hospital
Chongqing, Chongqing Municipality, 400000
About this study
Official title: Effects of Whey Protein Combined With Carbohydrates in the ERAS Protocol on the Recovery of Thyroid Cancer Patients After Lateral Neck Dissection: A Prospective Cohort Study
Exploring the effects of whey protein combined with carbohydrates in an Enhanced Recovery After Surgery (ERAS) protocol on the postoperative recovery of thyroid cancer patients undergoing lateral neck dissection, aiming to provide more precise research and guidance for the perioperative accelerated recovery plan in such patients. The goal is to accelerate postoperative recovery and reduce postoperative complications for thyroid cancer patients undergoing neck dissection.
Read the detailed description
Perioperative dietary management was differentiated between the two groups:
Experimental Group:
6 hours before surgery, patients orally consumed 250 ml of a full-nutrition liquid (220 ml homogenized diet, 50 g; containing 31.4 g carbohydrates, 8 g protein, and 215 kcal).
2 hours before surgery, patients orally consumed 200 ml of a clear liquid (50 g enzymatically hydrolyzed rice powder + 0.5 g low-sodium salt; containing 47.7 g carbohydrates, 6.5 g whey protein, and 193 kcal).
After surgery, once there were no symptoms such as dizziness or vomiting, patients could start consuming clear liquids (containing 47.7 g carbohydrates, 6.5 g protein, and 221 kcal) orally every 30 minutes, 4 times on the day of surgery.
Starting from the first day after surgery, patients consumed 200 ml of fat-free nutritional liquid (50 g enzymatically hydrolyzed rice powder + 7.5 g isolated whey protein + 0.5 g low-sodium salt; 223 kcal) per serving, 4 to 6 times per day as needed.
Control Group:
Patients fasted for 12 hours before surgery, and after surgery, intravenous fluids were administered. Fat-free diet began after 24 hours post-surgery.
Discharge Criteria: The discharge time was determined by the surgeon based on the patient's postoperative drainage condition and the presence or absence of complications.
- Being tested
- Whey Protein and Carbohydrates
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein and CarbohydratesDietary supplement
Experimental Group:
6 hours before surgery, patients orally consumed 250 ml of a full-nutrition liquid (220 ml homogenized diet, 50 g; containing 31.4 g carbohydrates, 8 g protein, and 215 kcal).
2 hours before surgery, patients orally consumed 200 ml of a clear liquid (50 g enzymatically hydrolyzed rice powder + 0.5 g low-sodium salt; containing 47.7 g carbohydrates, 6.5 g whey protein, and 193 kcal).
After surgery, once there were no symptoms such as dizziness or vomiting, patients could start consuming clear liquids (containing 47.7 g carbohydrates, 6.5 g protein, and 221 kcal) orally every 30 minutes, 4 times on the day of surgery.
Starting from the first day after surgery, patients consumed 200 ml of fat-free nutritional liquid (50 g enzymatically hydrolyzed rice powder + 7.5 g isolated whey protein + 0.5 g low-sodium salt; 223 kcal) per serving, 4 to 6 times per day as needed.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Experimental Group:
6 hours before surgery, patients orally consumed 250 ml of a full-nutrition liquid (220 ml homogenized diet, 50 g; containing 31.4 g carbohydrates, 8 g protein, and 215 kcal).
2 hours before surgery, patients orally consumed 200 ml of a clear liquid (50 g enzymatically hydrolyzed rice powder + 0.5 g low-sodium salt; containing 47.7 g carbohydrates, 6.5 g whey protein, and 193 kcal).
After surgery, once there were no symptoms such as dizziness or vomiting, patients could start consuming clear liquids (containing 47.7 g carbohydrates, 6.5 g protein, and 221 kcal) orally every 30 minutes, 4 times on the day of surgery.
Starting from the first day after surgery, patients consumed 200 ml of fat-free nutritional liquid (50 g enzymatically hydrolyzed rice powder + 7.5 g isolated whey protein + 0.5 g low-sodium salt; 223 kcal) per serving, 4 to 6 times per day as needed. Receives: Dietary Supplement: Whey Protein and Carbohydrates |
| control group | No intervention | Patients fasted for 12 hours before surgery, and after surgery, intravenous fluids were administered. Fat-free diet began after 24 hours post-surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin
Record the difference in indicators before and after surgery
Measured: 3 day
serum albumin
the difference in indicators before and after surgery.
Measured: 3 day
Postoperative Complication
Record the occurrence of related surgical complications in the experimental group and the control group.
Measured: 1 month
weight
Record the difference in indicators before and after surgery
Measured: 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Mar 2023
- Primary completion31 Mar 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whey ProteinStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607965
- Sponsor's protocol ID
- KY S2023-039-01
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whey Protein Combined With Carbohydrates in the ERAS Protocol on the Recovery of Thyroid Cancer Patients After Lateral Neck Dissection: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06607965
- Acronym / sponsor ID
- KY S2023-039-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Chongqing General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 23 Sep 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.
Exploring the effects of whey protein combined with carbohydrates in an Enhanced Recovery After Surgery (ERAS) protocol on the postoperative recovery of thyroid cancer patients undergoing lateral neck dissection, aiming to provide more precise research and guidance for the perioperative accelerated recovery plan in such patients. The goal is to accelerate postoperative recovery and reduce postoperative complications for thyroid cancer patients undergoing neck dissection.
Detailed description
Perioperative dietary management was differentiated between the two groups:
Experimental Group:
6 hours before surgery, patients orally consumed 250 ml of a full-nutrition liquid (220 ml homogenized diet, 50 g; containing 31.4 g carbohydrates, 8 g protein, and 215 kcal).
2 hours before surgery, patients orally consumed 200 ml of a clear liquid (50 g enzymatically hydrolyzed rice powder + 0.5 g low-sodium salt; containing 47.7 g carbohydrates, 6.5 g whey protein, and 193 kcal).
After surgery, once there were no symptoms such as dizziness or vomiting, patients could start consuming clear liquids (containing 47.7 g carbohydrates, 6.5 g protein, and 221 kcal) orally every 30 minutes, 4 times on the day of surgery.
Starting from the first day after surgery, patients consumed 200 ml of fat-free nutritional liquid (50 g enzymatically hydrolyzed rice powder + 7.5 g isolated whey protein + 0.5 g low-sodium salt; 223 kcal) per serving, 4 to 6 times per day as needed.
Control Group:
Patients fasted for 12 hours before surgery, and after surgery, intravenous fluids were administered. Fat-free diet began after 24 hours post-surgery.
Discharge Criteria: The discharge time was determined by the surgeon based on the patient's postoperative drainage condition and the presence or absence of complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Dietary Supplement: Whey Protein and CarbohydratesExperimental Group: 6 hours before surgery, patients orally consumed 250 ml of a full-nutrition liquid (220 ml homogenized diet, 50 g; containing 31.4 g carbohydrates, 8 g protein, and 215 kcal). 2 hours before surgery, patients orally consumed 200 ml of a clear liquid (50 g enzymatically hydrolyzed rice powder + 0.5 g low-sodium salt; containing 47.7 g carbohydrates, 6.5 g whey protein, and 193 kcal). After surgery, once there were no symptoms such as dizziness or vomiting, patients could start consuming clear liquids (containing 47.7 g carbohydrates, 6.5 g protein, and 221 kcal) orally every 30 minutes, 4 times on the day of surgery. Starting from the first day after surgery, patients consumed 200 ml of fat-free nutritional liquid (50 g enzymatically hydrolyzed rice powder + 7.5 g isolated whey protein + 0.5 g low-sodium salt; 223 kcal) per serving, 4 to 6 times per day as needed. |
| control group | No intervention | –Patients fasted for 12 hours before surgery, and after surgery, intravenous fluids were administered. Fat-free diet began after 24 hours post-surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older;
- Differentiated thyroid cancer with lateral lymph node dissection;
- Written informed consent provided by the participant.
Key exclusion criteria (5 listed)
- History of chronic liver or kidney disease, ischemic heart disease, or diabetes;
- Previous neck surgery or history of iodine-131 radiation;
- Allergy to soy or whey protein;
- Intraoperative chylous leak;
- Other special types of thyroid cancer.
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 Protein and CarbohydratesExperimental Group: 6 hours before surgery, patients orally consumed 250 ml of a full-nutrition liquid (220 ml homogenized diet, 50 g; containing 31.4 g carbohydrates, 8 g protein, and 215 kcal). 2 hours before surgery, patients orally consumed 200 ml of a clear liquid (50 g enzymatically hydrolyzed rice powder + 0.5 g low-sodium salt; containing 47.7 g carbohydrates, 6.5 g whey protein, and 193 kcal). After surgery, once there were no symptoms such as dizziness or vomiting, patients could start consuming clear liquids (containing 47.7 g carbohydrates, 6.5 g protein, and 221 kcal) orally every 30 minutes, 4 times on the day of surgery. Starting from the first day after surgery, patients consumed 200 ml of fat-free nutritional liquid (50 g enzymatically hydrolyzed rice powder + 7.5 g isolated whey protein + 0.5 g low-sodium salt; 223 kcal) per serving, 4 to 6 times per day as needed. | Dietary supplement | experimental group |
Primary outcome
hemoglobin
Time frame: 3 day
Record the difference in indicators before and after surgery
serum albumin
Time frame: 3 day
the difference in indicators before and after surgery.
Postoperative Complication
Time frame: 1 month
Record the occurrence of related surgical complications in the experimental group and the control group.
weight
Time frame: 1week
Record the difference in indicators before and after surgery
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 3 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Whey Protein
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Recruiting
GLycaemic Outcomes With Whey Protein in ageING
Type 2 Diabetes, Appetite Regulation
Recruiting
Whey Protein and Adaptogenic Supplementation in Physically Active Females
Sports Nutritional Sciences, Recovery
Not yet recruiting
Yeast Protein Supplementation and Muscle Preservation During GLP-1RA-Induced Weight Loss
Overweight and Obesity in Adults Receiving GLP-1RA Treatment
Recruiting
Whey Protein and Adaptogenic Supplementation in Physically Active Males
Sports Nutritional Sciences, Sports Nutrition
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 Protein and Carbohydrates in people with Whey Protein and Thyroid Neoplasms, run by Chongqing General Hospital at 1 site in China.
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 3 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 3 Dec 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 China. 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?
hemoglobin (time frame: 3 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2024.