Carbohydrate Drinks for Surgery Preparation

(CIPS Trial)

Overseen By Misty D Bechtel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Diabetes, Pregnancy, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective is to determine the impact of taking a specialized form of carbohydrate in the immediate preoperative period on metabolic markers, surgical outcomes and patient health. Patients will be randomized to receive a specialized sports drink or a standard sports drink. Patients will have a continuous glucose monitor (CGM) placed on their upper arm to measure glucose throughout surgery and during the post-operative period.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Gatorade, Gatorade G2, Gatorade Prime, Gatorade Recover, UCAN SuperStarch, UCAN SuperStarch, SuperStarch for surgery preparation?

Research suggests that consuming carbohydrate-based drinks before surgery can improve insulin sensitivity (how well the body uses insulin), enhance well-being, and reduce hospital stays. These benefits are seen with drinks that include carbohydrates, similar to those found in Gatorade and UCAN SuperStarch. ^{1 2 3 4 5}

Is it safe to consume carbohydrate drinks like Gatorade for surgery preparation?

Carbohydrate drinks, including those with low-calorie sweeteners, have been evaluated for safety and are generally considered safe for human consumption. The FDA and other authorities have approved many sweeteners used in these drinks, ensuring they do not pose harm. Additionally, studies on carbohydrate formats show no significant safety concerns, although some formats may cause mild gastrointestinal discomfort. ^{6 7 8 9 10}

How is UCAN SuperStarch different from other preoperative carbohydrate drinks?

UCAN SuperStarch is unique because it is a slow-releasing carbohydrate that may provide a more stable energy source compared to other carbohydrate drinks, which can help maintain blood sugar levels and reduce insulin spikes before surgery. ^{2 3 5 11 12}

Research Team

Jill M. Hamilton-Reeves

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

Adults over 18 scheduled for major urologic surgery lasting more than 4 hours can join this trial. They must be able to drink liquids and speak English.

Inclusion Criteria

I can swallow liquids.

I am scheduled for a major urologic surgery lasting more than 4 hours.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Carbohydrate Loading

Participants consume a specialized carbohydrate drink the night before and 2-3 hours before surgery

1 day

1 visit (in-person)

Surgery and Immediate Postoperative Monitoring

Participants undergo surgery and are monitored for glycemic variability and other metabolic markers

Up to 4 days

Inpatient stay

Follow-up

Participants are monitored for post-operative complications and clinical outcomes

90 days

Treatment Details

Interventions

• Gatorade
• UCAN SuperStarch

Trial Overview The study is testing if drinking a special sports drink (UCAN SuperStarch) or a standard one (Gatorade) before surgery affects metabolic markers, surgical outcomes, and patient health. Participants will be randomly given one of the drinks and monitored with a glucose tracker.

Participant Groups

Group I: UCAN SuperStarch study drinks Experimental Treatment 1 Intervention

Intervention group will receive UCAN SuperStarch study drinks. 100g carbohydrate will be consumed the night before surgery and 50g carbohydrate will be consumed 2 - 3 hours before surgery.

Group II: Gatorade study drinks Active Control 1 Intervention

Active Control group will receive Gatorade study drinks. 100g carbohydrate will be consumed the night before surgery and 50g carbohydrate will be consumed 2 - 3 hours before surgery.

UCAN SuperStarch is already approved in United States for the following indications:

Approved in United States as UCAN SuperStarch for:

• Preoperative carbohydrate loading for surgical patients

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Findings from Research

In a study of 83 non-diabetic patients undergoing colorectal surgery, preoperative loading with a low-dose complex carbohydrate solution (COM) resulted in significantly less glycemic variability compared to a simple carbohydrate solution (SIM).

Patients in the SIM group experienced higher rates of hyperglycemia and postoperative complications, suggesting that complex carbohydrates may be a safer and more effective option for managing blood sugar levels during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits of a low dose complex carbohydrate/citrulline electrolyte solution for preoperative carbohydrate loading: Focus on glycemic variability. Kielhorn, BA., Senagore, AJ., Asgeirsson, T.[2019]

In a study involving 12 healthy male participants, ingestion of a clear carbohydrate drink (CCD) resulted in higher peak glucose and insulin levels compared to a drink that also contained glutamine and antioxidants (ONS), indicating a more pronounced metabolic response to the CCD.

The ONS drink produced a 'blunted' and prolonged insulin and glucose response, suggesting that adding glutamine and antioxidants may help moderate postprandial insulin resistance, which could be beneficial for patients undergoing major surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized cross-over study of the metabolic and hormonal responses following two preoperative conditioning drinks. Awad, S., Fearon, KC., Macdonald, IA., et al.[2013]

In a study involving 11 healthy volunteers, both carbohydrate drinks and carbohydrate drinks with added glutamine showed similar gastric residual volumes after 2 and 3 hours, indicating efficient gastric emptying.

The addition of glutamine to carbohydrate drinks appears to be safe for consumption up to 2 hours before surgery, without negatively affecting gastric emptying.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric residual volume by magnetic ressonance after intake of maltodextrin and glutamine: a randomized double-blind, crossover study. Brianez, LR., Caporossi, C., de Moura, YW., et al.[2019]

A study involving 123 patients undergoing elective ophthalmologic surgery found that consuming a 200 mL carbohydrate drink 2 hours before surgery significantly reduced preoperative hunger and thirst compared to fasting patients.

Patients who had the carbohydrate drink reported higher satisfaction with anesthesia care post-surgery, suggesting that allowing limited oral intake can enhance patient comfort during day-stay procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A liberal preoperative fasting regimen improves patient comfort and satisfaction with anesthesia care in day-stay minor surgery. Bopp, C., Hofer, S., Klein, A., et al.[2022]

In a study of 47 low-risk women undergoing cesarean deliveries, consuming either a higher-dose carbohydrate beverage (Clearfast®) or a common rehydration solution (Gatorade) before surgery significantly improved patient well-being compared to fasting.

Both beverage groups reported better well-being on visual analogue scales, while the fasting group showed no improvement, indicating that preoperative carbohydrate consumption can enhance patient comfort without adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of oral carbohydrate consumption prior to cesarean delivery on preoperative well-being: a randomized interventional study. Wendling, AL., Byun, SY., Koenig, M., et al.[2021]

In a study involving 60 healthy volunteers with overweight/obesity, non-nutritive sweeteners (S&SE) significantly reduced insulin levels after a carbohydrate-rich meal compared to sucrose, indicating potential benefits for glycaemic control.

While some S&SE blends affected cholesterol levels and appetite sensations, they did not lead to significant differences in overall energy intake or cause serious gastrointestinal issues, suggesting they may be a safe alternative to sugar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of acute consumption of beverages containing plant-based or alternative sweetener blends on postprandial appetite, food intake, metabolism, and gastro-intestinal symptoms: Results of the SWEET beverages trial. Almiron-Roig, E., Navas-Carretero, S., Castelnuovo, G., et al.[2023]

The SUSTRA™ 2434 slowly digestible carbohydrate, made from tapioca flour and corn starch, showed a high slowly digestible fraction of 51% in vitro, indicating its potential for providing sustained energy.

In a study with 14 healthy adults, consuming foods containing this slowly digestible starch resulted in a lower glycemic index and a balanced release of energy, with lower blood glucose levels at 30-60 minutes and higher levels at 120-240 minutes post-consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slowly Digestible Carbohydrate for Balanced Energy: In Vitro and In Vivo Evidence. Gourineni, V., Stewart, ML., Skorge, R., et al.[2018]

Low calorie sweeteners like aspartame and saccharin have undergone extensive safety evaluations by regulatory bodies such as the FDA and EFSA, addressing concerns like cancer risk and effects on weight and metabolism.

Most modern sweeteners, including acesulfame K and sucralose, have been approved as safe through rigorous testing, ensuring they pose no significant health risks when consumed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and regulatory process for low calorie sweeteners in the United States. Roberts, A.[2018]

A study on the new sweetener sucromalt, administered to Sprague-Dawley rats at concentrations of 50, 100, and 200 g/kg for 28 days, showed no signs of toxicity or adverse effects on health, behavior, or organ function.

While there was a slight increase in food consumption and body weight gain (2-4%), these changes were not considered toxicologically relevant, indicating that sucromalt is safe for consumption at high levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 28-day oral (dietary) toxicity study of sucromalt in Sprague--Dawley rats. Eapen, AK., Chengelis, CP., Jordan, NP., et al.[2007]

In a study involving 12 well-trained male cyclists, carbohydrate bars were found to significantly reduce peak power output and increase gastrointestinal discomfort compared to gels, indicating they may be less effective for endurance performance.

While drinks and gels showed similar performance outcomes, carbohydrate bars led to higher levels of nausea and perceived exertion, suggesting they are not the best choice for athletes seeking optimal energy sources during intense exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solid, Gel, and Liquid Carbohydrate Format Effects on Gut Comfort and Performance. Guillochon, M., Rowlands, DS.[2017]

In a study involving 56 older adults (aged over 65), preoperative carbohydrate drinks did not significantly affect insulin resistance or gastric volume compared to a control group, indicating that these drinks are safe for this population before surgery.

The findings suggest that preoperative carbohydrate loading does not pose additional risks of insulin resistance or increased gastric volume in older adults undergoing total knee or hip arthroplasty, supporting its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Preoperative Oral Carbohydrates on Insulin Resistance in Older Adults Who Underwent Total Hip or Knee Arthroplasty: A Prospective Randomized Trial. Choi, YS., Cho, BW., Kim, HJ., et al.[2022]

In a study of 60 older adults undergoing total knee arthroplasty, drinking 400 mL of carbohydrate-containing fluid two hours before surgery resulted in a similar gastric volume compared to those who fasted overnight, indicating it is a safe option before surgery.

The mean gastric volume difference between the carbohydrate ingestion group and the fasting group was negligible (-1.9 mL), and the results met the predefined noninferiority margin, suggesting that carbohydrate drinks do not increase the risk of aspiration during anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound assessment of gastric volume in older adults after drinking carbohydrate-containing fluids: a prospective, nonrandomized, and noninferiority comparative study. Shin, HJ., Koo, BW., Lim, D., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The benefits of a low dose complex carbohydrate/citrulline electrolyte solution for preoperative carbohydrate loading: Focus on glycemic variability. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized cross-over study of the metabolic and hormonal responses following two preoperative conditioning drinks. [2013]

3. Brazil pubmed.ncbi.nlm.nih.gov

Gastric residual volume by magnetic ressonance after intake of maltodextrin and glutamine: a randomized double-blind, crossover study. [2019]

4. Italy pubmed.ncbi.nlm.nih.gov

A liberal preoperative fasting regimen improves patient comfort and satisfaction with anesthesia care in day-stay minor surgery. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Impact of oral carbohydrate consumption prior to cesarean delivery on preoperative well-being: a randomized interventional study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Impact of acute consumption of beverages containing plant-based or alternative sweetener blends on postprandial appetite, food intake, metabolism, and gastro-intestinal symptoms: Results of the SWEET beverages trial. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Slowly Digestible Carbohydrate for Balanced Energy: In Vitro and In Vivo Evidence. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

The safety and regulatory process for low calorie sweeteners in the United States. [2018]

9. England pubmed.ncbi.nlm.nih.gov

A 28-day oral (dietary) toxicity study of sucromalt in Sprague--Dawley rats. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

Solid, Gel, and Liquid Carbohydrate Format Effects on Gut Comfort and Performance. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of Preoperative Oral Carbohydrates on Insulin Resistance in Older Adults Who Underwent Total Hip or Knee Arthroplasty: A Prospective Randomized Trial. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Ultrasound assessment of gastric volume in older adults after drinking carbohydrate-containing fluids: a prospective, nonrandomized, and noninferiority comparative study. [2022]