Glycemic ResponseNCT04313920
Study of a Carbohydrate Drink in Adults
A study testing Nutritional Supplement in people with Glycemic Response, run by Abbott Nutrition at 3 sites in United States.
Trial summary
The objective of this study is to determine the postprandial glycemic response and rates of gastric emptying in healthy subjects and those with pre-diabetes and type 2 diabetes following oral ingestion of carbohydrate. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response
- What is being tested?
- Nutritional Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Apr 2020to 26 Aug 2020
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has voluntarily signed and dated an informed consent form and provided Health Insurance Portability and Accountability Act (HIPAA) authorization
- Subject is healthy or has pre-diabetes or type 2 diabetes
- Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum
- Subject's BMI is > 18.5 kg/m2 and ≤ 40.0 kg/m2
- If subject is on a chronic medication, the dosage has been constant
- Subject states willingness to follow protocol
Who cannot join
- Subject uses exogenous insulin or Glucagon-like peptide-1 (GLP-1) receptor agonists for glucose control
- Subject has type 1 diabetes
- Subject has a history of diabetic ketoacidosis
- Subject has current infection; has had in-patient surgery, or corticosteroid treatment or antibiotics
- Subject has an active malignancy
- Subject has had a significant cardiovascular event ≤ six months or history of congestive heart failure
Show all 15Show fewer
- Subject has end-stage organ failure or is status post organ transplant.
- Subject has a history of renal disease
- Subject has current hepatic disease
- Subject has a history of severe gastroparesis
- Subject has a chronic, contagious, infectious disease
- Subject has taken/is currently taking any herbals, dietary supplements, or medications that could profoundly affect blood glucose
- Subject has clotting or bleeding disorders
- Subject is known to be allergic or intolerant to any ingredient found in the study products
- Subject is a participant in another study that has not been approved as a concomitant study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Biofortis
Addison, Illinois, 60101
Great Lakes Clinical Trials
Chicago, Illinois, 60640
Health Awareness, Inc.
Jupiter, Florida, 33458
About this study
Official title: Postprandial Gastric Emptying and Glycemic Response to a Pre-Operative Carbohydrate Drink in Adults With Pre-diabetes and Type II Diabetes Mellitus
The objective of this study is to determine the postprandial glycemic response and rates of gastric emptying in healthy subjects and those with pre-diabetes and type 2 diabetes following oral ingestion of carbohydrate.
- Conditions
- Glycemic Response
- Being tested
- Nutritional Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional SupplementOther
50 g Carbohydrate
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Supplement | Experimental | Ready to drink liquid Receives: Other: Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose Concentration
Area under the curve
Measured: Baseline 0 to 240 Minutes
Secondary outcomes (4)
Serum Insulin Concentration
Area under the curve
Measured: Baseline 0 to 240 Minutes
Nutritional Product Assessment
Subject completed questionnaire with 2 product liking questions using 7-9 point Likert scale
Measured: Immediately following product consumption
Subjective Appetitive Ratings
Subject completed 4 visual analog scale statements scaled from Not at All to Extremely
Measured: Baseline 0 to 240 Minutes
Gastric Emptying
Rate of gastric emptying
Measured: Baseline 0 to 180 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start7 Apr 2020
- Primary completion26 Aug 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ResponseStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bridget Cassady, PhD, RDN, LD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313920
- Sponsor's protocol ID
- BL48
- Status last verified
- Oct 2020
- First submitted
- 11 Mar 2020
- Last updated
- 6 Oct 2020
- 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 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Gastric Emptying and Glycemic Response to a Pre-Operative Carbohydrate Drink in Adults With Pre-diabetes and Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04313920
- Acronym / sponsor ID
- BL48
- Conditions
- Glycemic Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 26 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 18 Mar 2020 (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.
The objective of this study is to determine the postprandial glycemic response and rates of gastric emptying in healthy subjects and those with pre-diabetes and type 2 diabetes following oral ingestion of carbohydrate.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplement | Experimental | Other: Nutritional SupplementReady to drink liquid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has voluntarily signed and dated an informed consent form and provided Health Insurance Portability and Accountability Act (HIPAA) authorization
- Subject is healthy or has pre-diabetes or type 2 diabetes
- Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum
- Subject's BMI is > 18.5 kg/m2 and ≤ 40.0 kg/m2
- If subject is on a chronic medication, the dosage has been constant
Key exclusion criteria (15 listed)
- Subject uses exogenous insulin or Glucagon-like peptide-1 (GLP-1) receptor agonists for glucose control
- Subject has type 1 diabetes
- Subject has a history of diabetic ketoacidosis
- Subject has current infection; has had in-patient surgery, or corticosteroid treatment or antibiotics
- Subject has an active malignancy
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 |
|---|---|---|
| Nutritional Supplement50 g Carbohydrate | Other | Nutritional Supplement |
Primary outcome
Plasma Glucose Concentration
Time frame: Baseline 0 to 240 Minutes
Area under the curve
4 secondary outcomes
Serum Insulin Concentration
Time frame: Baseline 0 to 240 Minutes
Nutritional Product Assessment
Time frame: Immediately following product consumption
Subjective Appetitive Ratings
Time frame: Baseline 0 to 240 Minutes
Gastric Emptying
Time frame: Baseline 0 to 180 Minutes
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 6 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Glycemic Response
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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
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Postprandial Glycemic and GLP-1 Responses to Modified Full-sugar Drinks
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Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
Not yet recruiting
A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
Postprandial Glucose, GI Tolerance
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.
Bridget Cassady, PhD, RDN, LD study chair
Abbott Nutrition
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Supplement in people with Glycemic Response, run by Abbott Nutrition at 3 sites 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 6 inclusion and 15 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Plasma Glucose Concentration (time frame: Baseline 0 to 240 Minutes). 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 6 Oct 2020.