Healthy DietNCT04790877

Effect of the Consumption of Alcohol-free Beers With Different Carbohydrates Composition on Postprandial Metabolic Response

A study testing Sub-study 1 and Sub-study 2 in people with Healthy Diet and Postprandial Hyperglycemia, run by Universidad de Zaragoza at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Diet, Postprandial Hyperglycemia
What is being tested?: Sub-study 1 and Sub-study 2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSpain
Study dates: 1 Feb 2020to 30 Mar 2021
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

BMI between 18.5 and 27.5 kg/m2.

Who cannot join

Presence of cardiometabolic pathology such as dyslipemia (total cholesterol > 200 mg/dL and/or triglycerides > 150 mg/dL, and/or taking lipid-lowering drugs), prediabetes or type 1 or 2 diabetes mellitus (glucose ≥ 100 mg/dL and/or glycosylated hemoglobin ≥ 5.7% and/or taking hypoglycemic drugs) or high blood pressure without drug treatment.
Presence of other chronic pathologies that could interfere with the results of the study such as cardiovascular disease, kidney disease, thyroid disease or liver disease.
Presence of intestinal malabsorption syndromes and/or presence of Chron disease or ulcerative colitis.
Use of drugs that may interfere with lipid and/or glycidic metabolism.
Presence of some analytical alteration that could interfere with the results of the study.
Increased or decreased body weight of ≥ 5 kg in the last 6 months.

Show all 10Show fewer

Gluten intolerance.
Regular intake of functional foods such as phytosterols or red rice yeast, which have a significant effect on lipid or glycidic metabolism, in the last 6 weeks.
Intake of vitamin supplements.
Hormone replacement therapy.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza
Zaragoza, 50009

Other trials in Spain

About this study

The overall objective of this study is to explore the glycemic index and glycemic load induced by an alcohol-free beer with modified composition (including almost full fermentation of carbohydrates and the addition of isomaltulose and a resistant maltodextrin), as well as its postprandial metabolic response, compared to the effect induced by: a) an alcohol-free beer with a usual composition; b) an alcohol-free beer with modified composition (including almost full fermentation of carbohydrates and the addition of a resistant maltodextrin). This study includes two cross-over sub-studies recruiting healthy participants. In the first one, 10 healthy volunteers receive 25 g of carbohydrates coming from: regular alcohol-free beer (RB), alcohol-free beer with almost completely eliminated maltose and enriched with isomaltulose (2.5 g/100 mL) and a resistant maltodextrin (0.8 g/100 mL) (IMB), alcohol-free beer with the same maltose removal enriched with resistant maltodextrin (2.0 g/100 mL) (MB) and glucose solution. In the second study, 20 healthy volunteers are provided with 50 g of carbohydrates from white bread and water and the same meal plus 14.3 g of carbohydrates coming from: RB, IMB, MB and extra white bread. Blood is sampled at baseline and for 2 h, every 15 min, after ingestion.

Conditions: Healthy Diet, Postprandial Hyperglycemia
Being tested: Sub-study 1, Sub-study 2
Keywords: Carbohydrates, Alcohol-free beer, Maltodextrin, Isomaltulose
Medical subject headings: Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sub-study 1Other
Subjects were provided with: a) Glucose beverage; b) Regular alcohol-free beer; c) Alcohol-free beer with modified composition (isomaltulose + maltodextrin); d) Alcohol-free beer with modified composition (++ maltodextrin).
Sub-study 2Other
Subjects were provided with: a) White bread + Water; b) White bread + Regular alcohol-free beer; c) White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin); d) White bread + Alcohol-free beer enriched with ++ maltodextrin; e) Extra-White bread + Water.

Study groups in NCT04790877
Study group	Role	What they receive
First sub-study: Glucose beverage	Active comparator	This intervention entails the intake of a beverage including 25 g of glucose. Receives: Other: Sub-study 1
First sub-study: Regular alcohol-free beer	Experimental	This intervention entails the intake of regular alcohol-free beer including 25 of carbohydrates. Receives: Other: Sub-study 1
First sub-study: Alcohol-free beer with modified composition (isomaltulose + maltodextrin)	Experimental	This intervention entails the intake of an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched with isomaltulose (2.5 g/100 mL) and a resistant maltodextrin (0.8 g/100 mL) (IMB). This beverage included 25 g of carbohydrates. Receives: Other: Sub-study 1
First sub-study: Alcohol-free beer with modified composition (++ maltodextrin)	Experimental	This intervention entails the intake of an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched with a resistant maltodextrin (2.0 g/100 mL) (MB). This beverage included 25 g of carbohydrates. Receives: Other: Sub-study 1
Second sub-study: White bread + Water	Active comparator	This intervention entails the intake of white bread (providing 50 g of carbohydrates) and water. Receives: Other: Sub-study 2
Second sub-study: White bread + Regular alcohol-free beer	Experimental	This intervention entails the intake of white bread (providing 50 g of carbohydrates) and regular alcohol-free beer (providing 14.3 g of carbohydrates). Receives: Other: Sub-study 2
Second sub-study: White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin)	Experimental	This intervention entails the intake of white bread (providing 50 g of carbohydrates) and an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched with isomaltulose (2.5 g/100 mL) and a resistant maltodextrin (0.8 g/100 mL) (IMB). This beverage included 14.3 g of carbohydrates. Receives: Other: Sub-study 2
Second sub-study: White bread + Alcohol-free beer enriched with ++ maltodextrin	Experimental	This intervention entails the intake of white bread (providing 50 g of carbohydrates) and an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched a resistant maltodextrin (2.0 g/100 mL) (MB). This beverage included 14.3 g of carbohydrates. Receives: Other: Sub-study 2
Second sub-study: Extra-White bread + Water	Active comparator	This intervention entails the intake of white bread which provides 64.3 g (50 g + 14.3 g) of carbohydrates and water. This intervention would be the comparator in carbohydrates-equally conditions. Receives: Other: Sub-study 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Glucose
Measured: Change from Baseline to 15-minutes after consumption of the beverage.
Glucose
Measured: Change from Baseline to 30-minutes after consumption of the beverage.
Glucose
Measured: Change from Baseline to 45-minutes after consumption of the beverage.
Glucose
Measured: Change from Baseline to 60-minutes after consumption of the beverage.
Glucose
Measured: Change from Baseline to 75-minutes after consumption of the beverage.
Glucose
Measured: Change from Baseline to 90-minutes after consumption of the beverage.
Glucose
Measured: Change from Baseline to 105-minutes after consumption of the beverage.
Glucose
Measured: Change from Baseline to 120-minutes after consumption of the beverage.
Insulin
Measured: Change from Baseline to 15-minutes after consumption of the beverage.
Insulin
Measured: Change from Baseline to 30-minutes after consumption of the beverage.
Insulin
Measured: Change from Baseline to 45-minutes after consumption of the beverage.
Insulin
Measured: Change from Baseline to 60-minutes after consumption of the beverage.
Insulin
Measured: Change from Baseline to 75-minutes after consumption of the beverage.
Insulin
Measured: Change from Baseline to 90-minutes after consumption of the beverage.
Insulin
Measured: Change from Baseline to 105-minutes after consumption of the beverage.
Insulin
Measured: Change from Baseline to 120-minutes after consumption of the beverage.
GLP-1
Measured: Change from Baseline to 15-minutes after consumption of the beverage.
GLP-1
Measured: Change from Baseline to 30-minutes after consumption of the beverage.
GLP-1
Measured: Change from Baseline to 45-minutes after consumption of the beverage.
GLP-1
Measured: Change from Baseline to 60-minutes after consumption of the beverage.
GLP-1
Measured: Change from Baseline to 75-minutes after consumption of the beverage.
GLP-1
Measured: Change from Baseline to 90-minutes after consumption of the beverage.
GLP-1
Measured: Change from Baseline to 105-minutes after consumption of the beverage.
GLP-1
Measured: Change from Baseline to 120-minutes after consumption of the beverage.
GIP
Measured: Change from Baseline to 15-minutes after consumption of the beverage.
GIP
Measured: Change from Baseline to 30-minutes after consumption of the beverage.
GIP
Measured: Change from Baseline to 45-minutes after consumption of the beverage.
GIP
Measured: Change from Baseline to 60-minutes after consumption of the beverage.
GIP
Measured: Change from Baseline to 75-minutes after consumption of the beverage.
GIP
Measured: Change from Baseline to 90-minutes after consumption of the beverage.
GIP
Measured: Change from Baseline to 105-minutes after consumption of the beverage.
GIP
Measured: Change from Baseline to 120-minutes after consumption of the beverage.

Secondary outcomes (16)

Leptin
Measured: Change from Baseline to 60-minutes after consumption of the beverage.
Leptin
Measured: Change from Baseline to 120-minutes after consumption of the beverage.
Glucagon
Measured: Change from Baseline to 60-minutes after consumption of the beverage.
Glucagon
Measured: Change from Baseline to 120-minutes after consumption of the beverage.
Ghrelin
Measured: Change from Baseline to 60-minutes after consumption of the beverage.
Ghrelin
Measured: Change from Baseline to 120-minutes after consumption of the beverage.
Polypeptide Y
Measured: Change from Baseline to 60-minutes after consumption of the beverage.
Polypeptide Y
Measured: Change from Baseline to 120-minutes after consumption of the beverage.
Pancreatic polypeptide
Measured: Change from Baseline to 60-minutes after consumption of the beverage.
Pancreatic polypeptide
Measured: Change from Baseline to 120-minutes after consumption of the beverage.
HDL cholesterol
Measured: Change from Baseline to 60-minutes after consumption of the beverage.
HDL cholesterol
Measured: Change from Baseline to 120-minutes after consumption of the beverage.
LDL cholesterol
Measured: Change from Baseline to 60-minutes after consumption of the beverage.
LDL cholesterol
Measured: Change from Baseline to 120-minutes after consumption of the beverage.
Triglycerides
Measured: Change from Baseline to 60-minutes after consumption of the beverage.
Triglycerides
Measured: Change from Baseline to 120-minutes after consumption of the beverage.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202030 Mar 2021

First posted10 Mar 2021
Study start1 Feb 2020
Primary completion31 Dec 2020
Study completion30 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy DietStudies 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Model description: The overall study involved two sub-studies. The first one includes 4 arms and the second one includes 5 arms.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04790877
Sponsor's protocol ID: PI19/477
Status last verified: Sep 2021
First submitted: 2 Mar 2021
Last updated: 30 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of the Consumption of Alcohol-free Beers With Different Carbohydrates Composition on Postprandial Metabolic Response
ClinicalTrials.gov ID: NCT04790877
Acronym / sponsor ID: PI19/477
Conditions: Healthy Diet, Postprandial Hyperglycemia
Keywords: Carbohydrates, Alcohol-free beer, Maltodextrin, Isomaltulose
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Universidad de ZaragozaUniversity, hospital or other
Collaborators: Instituto de Salud Carlos III
Study start: 1 Feb 2020 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 30 Mar 2021 (actual)
First posted: 10 Mar 2021 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 9
Model description: The overall study involved two sub-studies. The first one includes 4 arms and the second one includes 5 arms.

Arm	Type	Receives
First sub-study: Glucose beverage	Active comparator	Other: Sub-study 1This intervention entails the intake of a beverage including 25 g of glucose.
First sub-study: Regular alcohol-free beer	Experimental	Other: Sub-study 1This intervention entails the intake of regular alcohol-free beer including 25 of carbohydrates.
First sub-study: Alcohol-free beer with modified composition (isomaltulose + maltodextrin)	Experimental	Other: Sub-study 1This intervention entails the intake of an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched with isomaltulose (2.5 g/100 mL) and a resistant maltodextrin (0.8 g/100 mL) (IMB). This beverage included 25 g of carbohydrates.
First sub-study: Alcohol-free beer with modified composition (++ maltodextrin)	Experimental	Other: Sub-study 1This intervention entails the intake of an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched with a resistant maltodextrin (2.0 g/100 mL) (MB). This beverage included 25 g of carbohydrates.
Second sub-study: White bread + Water	Active comparator	Other: Sub-study 2This intervention entails the intake of white bread (providing 50 g of carbohydrates) and water.
Second sub-study: White bread + Regular alcohol-free beer	Experimental	Other: Sub-study 2This intervention entails the intake of white bread (providing 50 g of carbohydrates) and regular alcohol-free beer (providing 14.3 g of carbohydrates).
Second sub-study: White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin)	Experimental	Other: Sub-study 2This intervention entails the intake of white bread (providing 50 g of carbohydrates) and an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched with isomaltulose (2.5 g/100 mL) and a resistant maltodextrin (0.8 g/100 mL) (IMB). This beverage included 14.3 g of carbohydrates.
Second sub-study: White bread + Alcohol-free beer enriched with ++ maltodextrin	Experimental	Other: Sub-study 2This intervention entails the intake of white bread (providing 50 g of carbohydrates) and an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched a resistant maltodextrin (2.0 g/100 mL) (MB). This beverage included 14.3 g of carbohydrates.
Second sub-study: Extra-White bread + Water	Active comparator	Other: Sub-study 2This intervention entails the intake of white bread which provides 64.3 g (50 g + 14.3 g) of carbohydrates and water. This intervention would be the comparator in carbohydrates-equally conditions.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

BMI between 18.5 and 27.5 kg/m2.

Key exclusion criteria (10 listed)

Presence of cardiometabolic pathology such as dyslipemia (total cholesterol > 200 mg/dL and/or triglycerides > 150 mg/dL, and/or taking lipid-lowering drugs), prediabetes or type 1 or 2 diabetes mellitus (glucose ≥ 100 mg/dL and/or glycosylated hemoglobin ≥ 5.7% and/or taking hypoglycemic drugs) or high blood pressure without drug treatment.
Presence of other chronic pathologies that could interfere with the results of the study such as cardiovascular disease, kidney disease, thyroid disease or liver disease.
Presence of intestinal malabsorption syndromes and/or presence of Chron disease or ulcerative colitis.
Use of drugs that may interfere with lipid and/or glycidic metabolism.
Presence of some analytical alteration that could interfere with the results of the study.

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
Sub-study 1Subjects were provided with: a) Glucose beverage; b) Regular alcohol-free beer; c) Alcohol-free beer with modified composition (isomaltulose + maltodextrin); d) Alcohol-free beer with modified composition (++ maltodextrin).	Other	First sub-study: Alcohol-free beer with modified composition (++ maltodextrin), First sub-study: Alcohol-free beer with modified composition (isomaltulose + maltodextrin), First sub-study: Glucose beverage, First sub-study: Regular alcohol-free beer
Sub-study 2Subjects were provided with: a) White bread + Water; b) White bread + Regular alcohol-free beer; c) White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin); d) White bread + Alcohol-free beer enriched with ++ maltodextrin; e) Extra-White bread + Water.	Other	Second sub-study: Extra-White bread + Water, Second sub-study: White bread + Alcohol-free beer enriched with ++ maltodextrin, Second sub-study: White bread + Regular alcohol-free beer, Second sub-study: White bread + Water, Second sub-study: White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin)

Primary outcome

Glucose
Time frame: Change from Baseline to 15-minutes after consumption of the beverage.
Glucose
Time frame: Change from Baseline to 30-minutes after consumption of the beverage.
Glucose
Time frame: Change from Baseline to 45-minutes after consumption of the beverage.
Glucose
Time frame: Change from Baseline to 60-minutes after consumption of the beverage.
Glucose
Time frame: Change from Baseline to 75-minutes after consumption of the beverage.
Glucose
Time frame: Change from Baseline to 90-minutes after consumption of the beverage.
Glucose
Time frame: Change from Baseline to 105-minutes after consumption of the beverage.
Glucose
Time frame: Change from Baseline to 120-minutes after consumption of the beverage.
Insulin
Time frame: Change from Baseline to 15-minutes after consumption of the beverage.
Insulin
Time frame: Change from Baseline to 30-minutes after consumption of the beverage.
Insulin
Time frame: Change from Baseline to 45-minutes after consumption of the beverage.
Insulin
Time frame: Change from Baseline to 60-minutes after consumption of the beverage.
Insulin
Time frame: Change from Baseline to 75-minutes after consumption of the beverage.
Insulin
Time frame: Change from Baseline to 90-minutes after consumption of the beverage.
Insulin
Time frame: Change from Baseline to 105-minutes after consumption of the beverage.
Insulin
Time frame: Change from Baseline to 120-minutes after consumption of the beverage.
GLP-1
Time frame: Change from Baseline to 15-minutes after consumption of the beverage.
GLP-1
Time frame: Change from Baseline to 30-minutes after consumption of the beverage.
GLP-1
Time frame: Change from Baseline to 45-minutes after consumption of the beverage.
GLP-1
Time frame: Change from Baseline to 60-minutes after consumption of the beverage.
GLP-1
Time frame: Change from Baseline to 75-minutes after consumption of the beverage.
GLP-1
Time frame: Change from Baseline to 90-minutes after consumption of the beverage.
GLP-1
Time frame: Change from Baseline to 105-minutes after consumption of the beverage.
GLP-1
Time frame: Change from Baseline to 120-minutes after consumption of the beverage.
GIP
Time frame: Change from Baseline to 15-minutes after consumption of the beverage.
GIP
Time frame: Change from Baseline to 30-minutes after consumption of the beverage.
GIP
Time frame: Change from Baseline to 45-minutes after consumption of the beverage.
GIP
Time frame: Change from Baseline to 60-minutes after consumption of the beverage.
GIP
Time frame: Change from Baseline to 75-minutes after consumption of the beverage.
GIP
Time frame: Change from Baseline to 90-minutes after consumption of the beverage.
GIP
Time frame: Change from Baseline to 105-minutes after consumption of the beverage.
GIP
Time frame: Change from Baseline to 120-minutes after consumption of the beverage.

16 secondary outcomes

Leptin
Time frame: Change from Baseline to 60-minutes after consumption of the beverage.
Leptin
Time frame: Change from Baseline to 120-minutes after consumption of the beverage.
Glucagon
Time frame: Change from Baseline to 60-minutes after consumption of the beverage.
Glucagon
Time frame: Change from Baseline to 120-minutes after consumption of the beverage.
Ghrelin
Time frame: Change from Baseline to 60-minutes after consumption of the beverage.
Ghrelin
Time frame: Change from Baseline to 120-minutes after consumption of the beverage.
Polypeptide Y
Time frame: Change from Baseline to 60-minutes after consumption of the beverage.
Polypeptide Y
Time frame: Change from Baseline to 120-minutes after consumption of the beverage.
Pancreatic polypeptide
Time frame: Change from Baseline to 60-minutes after consumption of the beverage.
Pancreatic polypeptide
Time frame: Change from Baseline to 120-minutes after consumption of the beverage.
HDL cholesterol
Time frame: Change from Baseline to 60-minutes after consumption of the beverage.
HDL cholesterol
Time frame: Change from Baseline to 120-minutes after consumption of the beverage.
LDL cholesterol
Time frame: Change from Baseline to 60-minutes after consumption of the beverage.
LDL cholesterol
Time frame: Change from Baseline to 120-minutes after consumption of the beverage.
Triglycerides
Time frame: Change from Baseline to 60-minutes after consumption of the beverage.
Triglycerides
Time frame: Change from Baseline to 120-minutes after consumption of the beverage.

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 30 Sep 2021.
Individual participant dataSharing planned: No

Related trials for Healthy Diet

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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 Sub-study 1 and Sub-study 2 in people with Healthy Diet and Postprandial Hyperglycemia, run by Universidad de Zaragoza at 1 site in Spain.

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 1 inclusion and 10 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 30 Sep 2021. 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 Spain. 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?

Glucose (time frame: Change from Baseline to 15-minutes after consumption of the beverage.). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04790877.

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 30 Sep 2021.