Low Glycemic Index Shake for High Blood Sugar

(SHAKE Trial)

Overseen By Alicia Nguyen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Thyroid medication, Ozempic

Disqualifiers: Cancer, Cardiovascular, Renal, Hepatic, others

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a low glycemic index shake, called SP Glucose-Assist, can help control blood sugar levels when added to breakfast. It targets non-diabetic overweight and obese adults who eat three meals a day and maintain a stable weight. Participants will consume either a breakfast with this shake and oat cereal or just oat cereal over three weeks. The goal is to determine if the shake affects how the body processes sugar after eating. This approach may suit those seeking to improve blood sugar management without drastic diet changes. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance dietary strategies for better blood sugar control.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on thyroid medication, aspirin, or medications that affect weight or appetite.

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

Research shows that SP Glucose-Assist shakes are designed to help maintain healthy blood sugar levels. With a low glycemic index, they release sugar slowly into the blood, helping to prevent sudden spikes in blood sugar after meals.

Although specific safety data is not available, the product is generally intended for individuals with normal blood sugar levels, suggesting it is likely safe for study use. The information provided reports no serious side effects.

However, since the shake is meant to replace part of a meal, some individuals might experience mild digestive changes like bloating or gas, which are common when trying new foods. Consulting a healthcare provider before starting any new supplement or meal replacement is always advisable, especially for those with existing health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for managing high blood sugar, which often involve medication and strict dietary changes, the SP Glucose-Assist shake offers a unique nutritional approach. This shake is designed to have a low glycemic index, meaning it releases sugar more slowly into the bloodstream, potentially leading to better blood sugar control without drastic spikes. Researchers are excited about this shake because it could provide a simpler, more natural way to manage blood sugar levels, especially when combined with typical breakfasts like oat cereal. By focusing on dietary modifications rather than medications, this shake could be a game-changer for people looking for a more balanced approach to managing high blood sugar.

What evidence suggests that the SP Glucose-Assist shake might be an effective treatment for high blood sugar?

In this trial, participants in the experimental arm will consume a breakfast that includes the SP Glucose-Assist shake. Previous studies have shown that the SP Glucose-Assist shake helps reduce blood sugar spikes after meals. Specifically, research found that the shake lowered the rise in blood sugar levels by nearly 50% within the first hour after eating. This stabilization of blood sugar is important for overall health. The shake is designed to be low on the glycemic index, making it less likely to cause significant blood sugar jumps. While more information is needed about its effects with daily use, the shake shows promise for effectively managing blood sugar levels. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for non-diabetic adults aged 25-65 with a BMI of 25-40 who have maintained a stable weight (less than 5 pounds change) over the last two months. Participants should be willing to eat oat cereal for breakfast and typically consume three meals per day. They must also have glycated hemoglobin levels below 7%.

Inclusion Criteria

Body mass index 25-40

Eating pattern 3 meals a day

Stable weight for the last 2 months (<5 pounds fluctuation)

Exclusion Criteria

Night shifting work

Glycated hemoglobin >7%

Participating in another study at the same time

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Self-selected Diet

Participants follow a self-selected diet for one week

1 week

Dietary Intervention

Participants consume either a breakfast supplement shake or control cereal oat breakfast

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SP Glucose-Assist shake

Trial Overview The study tests if adding a low glycemic index nutritional shake, SP Glucose-Assist, to breakfast affects blood sugar control in overweight and obese adults. It's a three-week study where participants follow their usual diet for one week, then either add the shake or oat cereal to their breakfasts for two weeks.

How Is the Trial Designed?

Group I: Experimental: Breakfast with 200 kcal of oat ceral with honey + 200 kcal of glucose assist shake. Experimental Treatment 1 Intervention

Group II: Control: Breakfast with 400 kcal of oat cereal with honey Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Published Research Related to This Trial

In a study of 58 children with Type 1 Diabetes (T1D), consuming a whey isolate protein drink without additional insulin resulted in lower postprandial glycemia (PPG) when a square-wave insulin bolus was administered compared to no bolus, indicating that insulin may not be necessary for pure-protein meals.

The study also found that using a square-wave bolus significantly reduced the frequency of hypoglycemia compared to not using a bolus, suggesting that careful insulin management can help maintain better blood sugar levels after protein-rich meals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pure-protein load for children with type 1 diabetes: is any additional insulin needed? A randomized controlled study. Dżygało, K., Indulska, K., Szypowska, A.[2023]

In a pilot study involving 81 adults with type 2 diabetes, using a diabetes-specific nutritional shake (DSNS) as a breakfast replacement led to significantly greater reductions in postprandial glycemic response compared to those who maintained their usual diets.

Participants who consumed DSNS not only improved their glycemic control but also reported reduced cravings for starchy foods and increased confidence in managing their diabetes through dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a diabetes-specific nutritional shake to replace a daily breakfast and afternoon snack improves glycemic responses assessed by continuous glucose monitoring in people with type 2 diabetes: a randomized clinical pilot study. Mustad, VA., Hegazi, RA., Hustead, DS., et al.[2021]

Citations

1. my.standardprocess.com my.standardprocess.com/Products/Literature/Glucose-Assist-Fact-Sheet

Glucose Assist™ Glucose Assist™ is a low glycemic index protein shake that helps support healthy blood sugar levels already within a normal range.*. • Supports post-prandial ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2206056/

Effects of ingesting protein with various forms of carbohydrate ... Results from the present study indicate that glucose and insulin concentrations peaked 30-min following ingestion of CHO/PRO and then proceeded to decline for ...

3. standardprocess.com standardprocess.com/products/glucose-assist-vanilla

Glucose Assist™ Vanilla: Blood Sugar Support Shake Glucose Assist™ Vanilla is a low glycemic blood sugar support shake powder that helps support healthy blood sugar levels already in a normal range.*

4. mdpi.com mdpi.com/2072-6643/16/14/2237

A Novel Nutraceutical Supplement Lowers Postprandial ... The percentage reduction in the iAUC of blood glucose levels was 49.78% (iAUC0–60min) and 43.36% (iAUC0–120min), respectively, compared with the ...

5. med.stanford.edu med.stanford.edu/news/all-news/2025/06/carb-sugar-spikes.html

Blood sugar response to various carbohydrates can point to ... Participants whose blood sugar spiked after eating bread were more likely to have hypertension, or high blood pressure.

6. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-hidden-drug-ingredients-dr-ergins-sugarmd-advanced-glucose-support

Do not purchase or use Dr. Ergin's SugarMD Advanced ... Glyburide may pose serious and potentially life-threatening risks to consumers because this ingredient may result in unsafe drops in blood sugar ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5006666/

Dual Effect of Rosuvastatin on Glucose Homeostasis ... Our data shows dual effects on glucose homeostasis by rosuvastatin where insulin sensitivity is improved, but beta cell function is impaired.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0271531717300805

Addition of pooled pumpkin seed to mixed meals reduced ... Acute consumption of 65 g of pumpkin seed markedly reduced postprandial glycemia. Pumpkin seed has potential as a hypoglycemic food.