HyperglycemiaSHAKENCT06856460
The Impact of Low Glycemic Index Nutritional Shake on Glucose Regulation in Overweight and Obese Adults
A study testing powder shake with very low glycemic index and Ceral Breakfast in people with Hyperglycemia and Obesity Prevention, run by Arizona State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Obesity Prevention
- What is being tested?
- powder shake with very low glycemic index and Ceral Breakfast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2025to 9 Feb 2026
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index 25-40
- Eating pattern 3 meals a day
- stable weight for the last 2 months (<5 pounds fluctuation)
- Willing to eat oat cereal for breakfast
- glycated hemoglobin <7%
Who cannot join
- glycated hemoglobin >7%
- Body mass index ≤25 or ≥ 40
- Night shifting work
- Atypical meal pattern (not three meals a day or intermittent fasting)
- Thyroid medication
- Bariatric surgery
Show all 20Show fewer
- Habitual strenuous exercise
- Commuting by bicycle
- Eating disorders
- Use of aspirin during the duration of the study
- Intake of Vit C >60 mg/day during the study
- cancer
- cardiovascular disease
- renal disease
- hepatic disease
- X-ray, MRI or CT appointment during the study duration
- Current infection requiring medication
- Chronic, contagious, infectious diseases such as tuberculosis, Hepatitis A, B, C, or HIV
- Medications of supplements that could affect body weight or appetite (i.e. Ozempic)
- Participating in another study at the same time
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona State University 850 PBC
Phoenix, Arizona, 85004
About this study
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.
Read more
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.
- Conditions
- Hyperglycemia, Obesity Prevention
- Being tested
- powder shake with very low glycemic index, Ceral Breakfast
- Keywords
- meal replacement, glucose regulation
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
powder shake with very low glycemic indexDietary supplement
2 weeks of cereal and standard process glucose assist shake as part of breakfast. The diet for the remainder of the day will remain unchanged.
Ceral BreakfastDietary supplement
consume of 400kcal of oat-based cereal with honey for breakfast
| Study group | Role | What they receive |
|---|---|---|
| Control: Breakfast with 400 kcal of oat cereal with honey | Sham comparator | Not described Receives: Dietary Supplement: Ceral Breakfast |
| Experimental: Breakfast with 200 kcal of oat ceral with honey + 200 kcal of glucose assist shake. | Experimental | Not described Receives: Dietary Supplement: powder shake with very low glycemic index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose response between two breakfasts
The difference between the two breakfasts on the positive integer of the area under the curve for glucose during the 2 hours following breakfast ingestion.
Measured: the entire 2 hours of the glycemic test
Insulin responses between the two breakfasts
The difference between the two breakfasts on the positive integer of the area under the curve for insulin; during the 2 hours following breakfast ingestion.
Measured: The entire 2 hours period
Glucose réponses during glucose challenge test
Positive integer of the area under the curve for glucose during the 2 hours glycemic test
Measured: 2 hours post ingestion of the emperimental meal (cereal or ceral + shake)
Insulin responses during the glucemic challenge test
Positive integer of the area under the curve for insulin during the 2-hours glycemic test
Measured: 2 hour post ingestion of the intervention meal (cereal or cereal + shake)
Secondary outcomes (7)
Ambulatory glucose profile
The difference between the two groups on the area under the curve in Ambulatory glucose measured with a continuous glucose monitor during the 2 weeks of dietary intervention.
Measured: total area under the curve during the 2 weeks (14 days) of dietary intervention.
Blood glucagon
Blood glucagon difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)
Measured: 0, 30, 60, 90, and 120 minutes of the glycemic test.
Glucagon like peptide 1
Blood Glucagon like peptide difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)
Measured: 0, 30, 60, 90, and 120 minutes of the glycemic test.
Leptin
Blood Leptin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)
Measured: 0, 30, 60, 90, and 120 minutes of the glycemic test.
Adiponectin
Blood Adiponectin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)
Measured: 0, 30, 60, 90, and 120 minutes of the glycemic test.
Ghrelin
Blood Ghrelin difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)
Measured: 0, 30, 60, 90, and 120 minutes of the glycemic test.
C-Peptide
Blood c-peptide difference between day 7 and day 21 during the 2 hours glycemic challenge (400 kilocalories consumption of the oat or oat and glucose assist shake)
Measured: 0, 30, 60, 90, and 120 minutes of the glycemic test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start18 Mar 2025
- Primary completion14 Nov 2025
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms: one group will undergo 2 weeks of a meal replacement shake for breakfast with oat cereal and the other group will consume only oat cereal (isocaloric 400 kilocarolies)
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stavros Kavouras, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856460
- Sponsor's protocol ID
- STUDY00016899
- Acronym
- SHAKE
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Low Glycemic Index Nutritional Shake on Glucose Regulation in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT06856460
- Acronym / sponsor ID
- SHAKE / STUDY00016899
- Conditions
- Hyperglycemia, Obesity Prevention
- Keywords
- meal replacement, glucose regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 4 Mar 2025 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arms: one group will undergo 2 weeks of a meal replacement shake for breakfast with oat cereal and the other group will consume only oat cereal (isocaloric 400 kilocarolies)
| Arm | Type | Receives |
|---|---|---|
| Control: Breakfast with 400 kcal of oat cereal with honey | Sham comparator | Dietary Supplement: Ceral Breakfast |
| Experimental: Breakfast with 200 kcal of oat ceral with honey + 200 kcal of glucose assist shake. | Experimental | Dietary Supplement: powder shake with very low glycemic index |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index 25-40
- Eating pattern 3 meals a day
- stable weight for the last 2 months (<5 pounds fluctuation)
- Willing to eat oat cereal for breakfast
- glycated hemoglobin <7%
Key exclusion criteria (20 listed)
- glycated hemoglobin >7%
- Body mass index ≤25 or ≥ 40
- Night shifting work
- Atypical meal pattern (not three meals a day or intermittent fasting)
- Thyroid medication
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 |
|---|---|---|
| powder shake with very low glycemic index2 weeks of cereal and standard process glucose assist shake as part of breakfast. The diet for the remainder of the day will remain unchanged. | Dietary supplement | Experimental: Breakfast with 200 kcal of oat ceral with honey + 200 kcal of glucose assist shake. |
| Ceral Breakfastconsume of 400kcal of oat-based cereal with honey for breakfast | Dietary supplement | Control: Breakfast with 400 kcal of oat cereal with honey |
Primary outcome
Glucose response between two breakfasts
Time frame: the entire 2 hours of the glycemic test
The difference between the two breakfasts on the positive integer of the area under the curve for glucose during the 2 hours following breakfast ingestion.
Insulin responses between the two breakfasts
Time frame: The entire 2 hours period
The difference between the two breakfasts on the positive integer of the area under the curve for insulin; during the 2 hours following breakfast ingestion.
Glucose réponses during glucose challenge test
Time frame: 2 hours post ingestion of the emperimental meal (cereal or ceral + shake)
Positive integer of the area under the curve for glucose during the 2 hours glycemic test
Insulin responses during the glucemic challenge test
Time frame: 2 hour post ingestion of the intervention meal (cereal or cereal + shake)
Positive integer of the area under the curve for insulin during the 2-hours glycemic test
7 secondary outcomes
Ambulatory glucose profile
Time frame: total area under the curve during the 2 weeks (14 days) of dietary intervention.
Blood glucagon
Time frame: 0, 30, 60, 90, and 120 minutes of the glycemic test.
Glucagon like peptide 1
Time frame: 0, 30, 60, 90, and 120 minutes of the glycemic test.
Leptin
Time frame: 0, 30, 60, 90, and 120 minutes of the glycemic test.
Adiponectin
Time frame: 0, 30, 60, 90, and 120 minutes of the glycemic test.
Ghrelin
Time frame: 0, 30, 60, 90, and 120 minutes of the glycemic test.
C-Peptide
Time frame: 0, 30, 60, 90, and 120 minutes of the glycemic test.
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 13 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Hyperglycemia
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight
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 powder shake with very low glycemic index and Ceral Breakfast in people with Hyperglycemia and Obesity Prevention, run by Arizona State University at 1 site in United States.
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 5 inclusion and 20 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 13 Feb 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Glucose response between two breakfasts (time frame: the entire 2 hours of the glycemic test). 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 13 Feb 2026.