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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of a specialized carbohydrate drink on individuals undergoing major urologic surgery. The researchers aim to determine if consuming UCAN SuperStarch before surgery improves health outcomes compared to a standard sports drink like Gatorade. Participants will wear a glucose monitor to track blood sugar levels before, during, and after surgery. Adults who can swallow liquids, speak English, and are scheduled for major urologic surgery lasting more than four hours may qualify for this trial. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance surgical recovery for future patients.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that UCAN SuperStarch is generally safe for people. Studies have found that consuming carbohydrate drinks like SuperStarch before surgery can be safe and might help with insulin resistance, a condition where the body doesn't use insulin effectively. This could improve sugar management during and after surgery.

Reports from similar studies suggest no major safety concerns with using SuperStarch before surgery. Although some studies indicate that more research is needed, SuperStarch is considered likely safe for surgical preparation. Overall, existing evidence supports its safety for surgical patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for carbohydrate drinks in surgery preparation because it explores how UCAN SuperStarch compares to traditional options like Gatorade. Unlike typical carbohydrate drinks that cause quick spikes and crashes in blood sugar levels, UCAN SuperStarch provides a steady release of energy. This could help maintain stable blood sugar levels before surgery, potentially improving patient outcomes and recovery times. By understanding the effects of different carbohydrate sources, this trial might lead to more effective pre-surgery nutrition protocols.

What evidence suggests that this trial's treatments could be effective for surgery preparation?

Research has shown that consuming carbohydrate-rich beverages before surgery can improve recovery. These drinks help maintain steady blood sugar levels, reduce stress, and increase comfort post-surgery. Patients who consumed these beverages reported feeling less thirsty and tired and demonstrated better focus. Specifically, drinks with more than 50 grams of carbohydrates proved more effective than those with less. In this trial, participants will receive either UCAN SuperStarch or Gatorade as part of their preparation. UCAN SuperStarch is a specialized carbohydrate designed to support these pre-surgery benefits. ^{4 6 7 8 9}

Who Is on the Research Team?

Jill M. Hamilton-Reeves

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

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]

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9726728/

Effects of preoperative carbohydrate loading on recovery after ... The present meta-analysis found that oral high-dose carbohydrate (>50 g) was more effective in postoperative outcomes than relative to low-dose carbohydrate, ...

2. jogs.one jogs.one/jogs_1220/

Effect of preoperative oral carbohydrate loading on early ... Administering a carbohydrate-rich drink before surgery helps maintain euglycemia, reduce the insulin surge, decrease the stress response, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5137663/

Role of preoperative carbohydrate loading: a systematic review Preoperative carbohydrate drinks significantly improved insulin resistance and indices of patient comfort following surgery, especially hunger, thirst, malaise ...

4. clinmedjournals.org clinmedjournals.org/articles/jnmdc/journal-of-nutritional-medicine-and-diet-care-jnmdc-5-036.php

Does Preoperative Carbohydrate Loading Help Outcomes ... The study concluded that patients who received pre-operative carbohydrate loading had reduced thirst, fatigue and improved concentration. Ljunggren, et al. [10] ...

5. qualityhealth.org qualityhealth.org/scoap/wp-content/uploads/sites/2/2021/06/SCOAP-Preoperative-Carbohydrate-Loading-FINAL.pdf

Pre-Operative Carbohydrate Loading Rationale: Research indicates that a preoperative carbohydrate supplement two to three hours prior to surgery may optimize glucose control, decrease insulin ...

6. isrctn.com isrctn.com/ISRCTN45230380

ISRCTN45230380: SuperStarch Study In this study, patients having bowel surgery are given either Generation UCAN or the standard sugar-based drink PreLoad® before their operation. The research ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06057532

Carbohydrate Ingestion Prior to Surgery (CIPS) The objective is to determine the impact of taking a specialized form of carbohydrate in the immediate preoperative period on metabolic markers, ...

8. isrctn.com isrctn.com/pdf/45230380

SuperStarch Study It has been shown that having a sugar-based carbohydrate drink before surgery can prevent the development of insulin resistance. As a result ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34999325/

A systematic review and network meta-analysis of phase II ... Both preoperative CHO loading and clear water use were superior to the fasting about morbidity. CHO drinks use could provide specific ...