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

Trial Summary

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.

What data supports the effectiveness of the treatment SP Glucose-Assist shake for high blood sugar?

Research shows that using a low glycemic index shake as a meal replacement can help lower blood sugar levels after meals in people with type 2 diabetes, suggesting that the SP Glucose-Assist shake might have similar benefits. ^{1 2 3 4 5}

Is the Low Glycemic Index Shake safe for humans?

The Low Glycemic Index Shake, also known as a diabetes-specific nutritional shake, has been studied in people with type 2 diabetes and healthy volunteers. These studies did not report any major safety concerns, suggesting it is generally safe for human consumption. ^{1 2 4 6 7}

How does the low glycemic index shake differ from other treatments for high blood sugar?

The low glycemic index shake is unique because it contains retrograded starch, which helps maintain a lower and more stable blood sugar level compared to other high glycemic foods. This shake's effectiveness can vary based on individual factors like fasting insulin levels, making it a personalized approach to managing blood sugar. ^{5 6 8 9 10}

What is the purpose of this trial?

Low glycemic index nutritional shakes have clinically shown to improve post-prandial glycemic responses in acute laboratory control studies. However, there is limited information on how replacing meals with low-glycemic index shake could impact glucose regulation in free-living adults consuming their own diets. The present study aims to examine the impact of adding the SP Glucose-Assist shake to the breakfast of non-diabetic overweight and obese adults. Subjects: 40 non-diabetic adults aged 25-65 years and body mass index ranging between 25-39 . Protocol: This is going to be a three-week study that will include a one-week self-selected diet, followed by two weeks of a breakfast supplement shake (standard process glucose assist) or control cereal oat breakfast.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England 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. [2021]

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

Biobehavioral Changes Following Transition to Automated Insulin Delivery: A Large Real-life Database Analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Breakfast replacement with a low-glycaemic response liquid formula in patients with type 2 diabetes: a randomised clinical trial. [2022]

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

Glycemic Index, Extended Bolusing, and Diabetes Education in Insulin Pump Therapy (GLIDE: A Pilot Study). [2022]

5. Czech Republic pubmed.ncbi.nlm.nih.gov

Safety of new algorithms for premeal insulin boluses in high glycaemic index meals in persons with type 1 diabetes mellitus using insulin pumps. [2019]

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

Complete nutrition drink with retrograded starch is low glycemic, and the individual glucose response to the low glycemic complete nutrition drink depends on fasting insulin levels and HOMA-IR in a randomized cross-over control trial. [2022]

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

Influence of and optimal insulin therapy for a low-glycemic index meal in children with type 1 diabetes receiving intensive insulin therapy. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Glycemic Index of Slowly Digestible Carbohydrate Alone and in Powdered Drink-Mix. [2020]

9. Japan pubmed.ncbi.nlm.nih.gov

[The application of the glycemic index to the treatment of diabetes mellitus in the elderly]. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

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