Glucose Metabolism Disorders (Including Diabetes Mellitus)NCT03337828
Effect of Two Alcohol-free Beers With Different Carbohydrates Composition on Lipids and Glucose Metabolism
A study testing Alcohol-free beer with regular composition and Alcohol-free beer with modified composition in people with Glucose Metabolism Disorders (Including Diabetes Mellitus) and Overweight and Obesity, run by Instituto Aragones de Ciencias de la Salud at 1 site in Spain.
Trial summary
This a controlled, double-blind, randomized, cross designed study to determine the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on glycemic metabolism (glucose, glycated hemoglobin, insulin… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glucose Metabolism Disorders (Including Diabetes Mellitus), Overweight and Obesity
- What is being tested?
- Alcohol-free beer with regular composition and Alcohol-free beer with modified composition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2017to Dec 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years.
- To provide informed consent in writing of voluntary participation in the study after having read the participant information sheet, and having consulted the doubts that may arise from it.
- Diagnosis of prediabetes or diabetes mellitus type 2 defined as: a) fasting glucose ≥ 100 mg/dL in the last 3 months; b) glycated hemoglobin ≥ 5.7% and ≤ 6.5%.
Who cannot join
- Gluten intolerance.
- Taking lipid-lowering drugs.
- Taking antidiabetic drugs, except for metformin in a stable dose in the last 3 months.
- To be under treatment with insulin.
- Presence of uncontrolled endocrinological disease by including hypothyroidism.
- Regular intake of functional foods with plant sterols in the past 6 weeks.
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- Intake of vitamin supplements.
- Hormone replacement therapy.
- High intake of alcohol (> 30 g ethanol) on a regular basis.
- Pregnancy or intention of pregnancy during the study since the proposed nutritional intervention may not be suitable for this situation.
- Serious illness of any type with less than 1-year life expectancy or if, in the opinion of the investigators, it would limit a stable diet throughout the study.
- To be under treatment with corticosteroids, hormonal treatment or antibiotics the 3 months prior to randomization.
- To take prebiotics, probiotics, vitamin supplements and any other drug that could influence the intestinal microbiota, in the 3 months prior to randomization.
- Any other circumstances which, according to researcher's assessment, could interfere with the correct development of nutritional intervention (e.g.: frequent trips during the study, failure to attend visits by personal or business circumstances, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Cross-over Study Comparing the Effect of Two Alcohol-free Beers With Different Carbohydrates Composition on Lipid and Glycemic Metabolism in Subjects With Prediabetes and Recently Diagnosed Diabetes and Overweight or Obesity
This a controlled, double-blind, randomized, cross designed study to determine the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on glycemic metabolism (glucose, glycated hemoglobin, insulin and HOMA index) in subjects with recently diagnosed diabetes mellitus and overweight or obesity. 44 subjects were randomized to consume for 10 weeks: a) two alcohol-free beers with regular carbohydrates composition per day; b) two alcohol-free beers with modified carbohydrates composition per day. Those subjects randomized to begin with A beer during 10 weeks will change to B beer during the second phase for 10 weeks and vice versa. There is a 4-8 weeks wash-out period between two phases.
Read the detailed description
The study involves a nutritional intervention with a controlled, double-blind, randomized, cross design. It includes 44 healthy subjects with a total duration of 20 weeks with a "wash-out/stabilization" period for 2-4 weeks before randomization. Subjects are randomized in two groups: (1) those who begin drinking 2 alcohol-free beers (33 cl each one) that are enriched in a resistant maltodextrin and isomaltulose during 10 weeks and continue drinking 2 alcohol-free beers (33 cl each one) with regular composition during the next 10 weeks following; (2) those who will follow the same previous intervention but in reverse, beginning with standard alcohol-free beer for 10 weeks, followed by resistant maltodextrin and isomaltulose-enriched beer for the remaining 10 weeks. There is a washout period between both phases to facilitate adherence to nutritional intervention, since we consider that a period of 20 consecutive weeks could be difficult to assume for the participants. Participants and the research team are "blind" to the type of beer that subjects are taking in each phase. Only one person of the company that provide beers, which does not directly participate in the clinic visits or in the analysis of the data, is aware of this information. Clinical staff performed the randomization based on a computerized method.
Among those subjects included in the study, microbiota sub-study is proposed which require a specific authorization within informed consent. Among all subjects that are included in this substudy and that have completed the whole nutritional intervention, 10 subjects (5 from each randomized group) will be selected to microbiota determination.
- Study visits:
- Prescreening visit: Inclusion and exclusion criteria assessment and blood collection if glucose or glycated hemoglobin is not available in previous 3 months. Healthy diet and physical activity counselling is provided by a nutritionist; it should be maintained during all study. Baseline visit is scheduled in 2-4 weeks after lifestyle stabilization.
- Baseline phase 1 visit: Clinical, biochemical, dietary, physical activity and anthropometric data are assessed. Computer-based randomization is performed. Alcohol-free beer (A or B according to randomization procedures) for the next 10 weeks is delivered to the participant who has to consume two per day. A nutritionist emphasizes healthy lifestyle counselling to the participant. A feces sample is collected if subjects accept to be included in microbiota sub study.
- Intermediate phase 1 visit: Clinical, biochemical, dietary, physical activity and anthropometric data are assessed. Satiety after alcohol-free beer consumption is measured by a validated questionnaire. A nutritionist emphasizes healthy lifestyle counselling to the participant.
- End of phase 1 visit: Clinical, biochemical, dietary, physical activity and anthropometric data are assessed. Satiety after alcohol-free beer consumption is measured by a validated questionnaire. A nutritionist emphasizes healthy lifestyle counselling to the participant. A wash-out period of 4-8 weeks is scheduled before the next phase start. A feces sample is collected if subjects accept to be included in microbiota sub study.
- Baseline phase 2 visit: Clinical, biochemical, dietary, physical activity and anthropometric data are assessed. Alcohol-free beer (A or B: if subjects consumed alcohol-free beer A, he/she change to alcohol-free B and vice versa) for the next 10 weeks is delivered to the participant who has to consume two per day. A nutritionist emphasizes healthy lifestyle counselling to the participant. A feces sample is collected if subjects accept to be included in microbiota sub study.
- Intermediate phase 2 visit: Clinical, biochemical, dietary, physical activity and anthropometric data are assessed. Satiety after alcohol-free beer consumption is measured by a validated questionnaire. A nutritionist emphasizes healthy lifestyle counselling to the participant.
- End of phase 2 visit: Clinical, biochemical, dietary, physical activity and anthropometric data are assessed. Satiety after alcohol-free beer consumption is measured by a validated questionnaire. A nutritionist emphasizes healthy lifestyle counselling to the participant. A feces sample is collected if subjects accept to be included in microbiota sub study.
- Study variables:
- Clinical variables: Gender, age, medical records including diseases and medication, tobacco consumption and blood pressure.
- Anthropometric variables: Weight, height, body mass index, waist circumference, body composition analysis.
- Biochemical variables: Glucose, lipid and iron metabolism are assessed. Inflammatory biomarkers, including C reactive protein, are also determined.
- Microbiota: Feces samples are collected to microbiota analysis including Bacteroides, Lactobacillus, Enterococcus, Prevotella or Roseburia, among others.
- Dietary and physical activity assessment: Diet and physical activity are assessed by validated questionnaires.
- Being tested
- Alcohol-free beer with regular composition, Alcohol-free beer with modified composition
- Keywords
- Alcohol-free beer, Carbohydrates, Overweight, Obesity, Diabetes mellitus type 2, Microbiota, Glucose metabolism
- Medical subject headings
- Glucose Metabolism Disorders, Overweight, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol-free beer with regular compositionOther
Subjects are provided with 2 alcohol-free beers with regular carbohydrates composition per day and healthy diet counselling during 10 weeks.
Alcohol-free beer with modified compositionOther
Subjects are provided with 2 alcohol-free beers with modified carbohydrates composition per day and healthy diet counselling during 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol-free beer with regular composition | Active comparator | Two cans (33 cl.) per day of an alcohol-free beer with regular carbohydrates composition. Receives: Other: Alcohol-free beer with regular composition |
| Alcohol-free beer with modified composition | Experimental | Two cans (33 cl.) per day of alcohol-free beer with modified carbohydrates composition. This include the substitution of regular maltose by isomaltulose and the addition of maltodextrin (fiber). Receives: Other: Alcohol-free beer with modified composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose concentration change after each alcohol-free beer phase.
Main objective is to determine the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on glucose concentration change.
Measured: 10 weeks
Glycated hemoglobin concentration change after each alcohol-free beer phase.
Main objective is to determine the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on glycated hemoglobin concentration change.
Measured: 10 weeks
Insulin concentration change after each alcohol-free beer phase.
Main objective is to determine the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on insulin concentration change.
Measured: 10 weeks
Homeostatic model assessment (HOMA) index change after each alcohol-free beer phase.
Main objective is to determine the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on HOMA index change.
Measured: 10 weeks
Secondary outcomes (4)
Lipid profile change after each alcohol-free beer phase.
Secondary objective involves determining the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on LDL cholesterol concentration change.
Measured: 10 weeks
Body weight change after each alcohol-free beer phase.
Secondary objective involves determining the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on body weight.
Measured: 10 weeks
C reactive protein concentration change after each alcohol-free beer phase.
Secondary objective involves determining the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on C reactive protein change.
Measured: 10 weeks
Micriobota change after each alcohol-free beer phase.
Secondary objective involves determining the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on microbiota.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start1 Mar 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glucose Metabolism Disorders (Including Diabetes Mellitus)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Aragones de Ciencias de la Salud
- Sponsor type
- Other government
- Collaborators
- Aragon Institute of Health Sciences
- Responsible party
- Principal investigator, Fernando Civeira, Aragon Institute of Health Sciences
- Investigators
- Rocio Mateo-Gallego, RD, PhD, Principal investigator, Aragon Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337828
- Sponsor's protocol ID
- CEICA PI16/0277
- Status last verified
- Nov 2017
- First submitted
- 31 Oct 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mateo-Gallego R , Moreno-Indias I , Bea AM , Sanchez-Alcoholado L , Fumanal AJ , Quesada-Molina M , Prieto-Martin A , Gutierrez-Repiso C , Civeira F , Tinahones FJ . An alcohol-free beer enriched with isomaltulose and a resistant dextrin modulates gut microbiome in subjects with type 2 diabetes mellitus and overweight or obesity: a pilot study. Food Funct. 2021 Apr 21;12(8):3635-3646. doi: 10.1039/d0fo03160g. Epub 2021 Mar 31.
PubMed 33900319Mateo-Gallego R, Perez-Calahorra S, Lamiquiz-Moneo I, Marco-Benedi V, Bea AM, Fumanal AJ, Prieto-Martin A, Laclaustra M, Cenarro A, Civeira F. Effect of an alcohol-free beer enriched with isomaltulose and a resistant dextrin on insulin resistance in diabetic patients with overweight or obesity. Clin Nutr. 2020 Feb;39(2):475-483. doi: 10.1016/j.clnu.2019.02.025. Epub 2019 Mar 5.
PubMed 30879735
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Cross-over Study Comparing the Effect of Two Alcohol-free Beers With Different Carbohydrates Composition on Lipid and Glycemic Metabolism in Subjects With Prediabetes and Recently Diagnosed Diabetes and Overweight or Obesity
- ClinicalTrials.gov ID
- NCT03337828
- Acronym / sponsor ID
- CEICA PI16/0277
- Keywords
- Alcohol-free beer, Carbohydrates, Overweight, Obesity, Diabetes mellitus type 2, Microbiota, Glucose metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Instituto Aragones de Ciencias de la SaludOther government
- Collaborators
- Aragon Institute of Health Sciences
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Nov 2017 (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.
This a controlled, double-blind, randomized, cross designed study to determine the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on glycemic metabolism (glucose, glycated hemoglobin, insulin and HOMA index) in subjects with recently diagnosed diabetes mellitus and overweight or obesity. 44 subjects were randomized to consume for 10 weeks: a) two alcohol-free beers with regular carbohydrates composition per day; b) two alcohol-free beers with modified carbohydrates composition per day. Those subjects randomized to begin with A beer during 10 weeks will change to B beer during the second phase for 10 weeks and vice versa. There is a 4-8 weeks wash-out period between two phases.
Detailed description
The study involves a nutritional intervention with a controlled, double-blind, randomized, cross design. It includes 44 healthy subjects with a total duration of 20 weeks with a "wash-out/stabilization" period for 2-4 weeks before randomization. Subjects are randomized in two groups: (1) those who begin drinking 2 alcohol-free beers (33 cl each one) that are enriched in a resistant maltodextrin and isomaltulose during 10 weeks and continue drinking 2 alcohol-free beers (33 cl each one) with regular composition during the next 10 weeks following; (2) those who will follow the same previous intervention but in reverse, beginning with standard alcohol-free beer for 10 weeks, followed by resistant maltodextrin and isomaltulose-enriched beer for the remaining 10 weeks. There is a washout period between both phases to facilitate adherence to nutritional intervention, since we consider that a period of 20 consecutive weeks could be difficult to assume for the participants. Participants and the research team are "blind" to the type of beer that subjects are taking in each phase. Only one person of the company that provide beers, which does not directly participate in the clinic visits or in the analysis of the data, is aware of this information. Clinical staff performed the randomization based on a computerized method.
Among those subjects included in the study, microbiota sub-study is proposed which require a specific authorization within informed consent. Among all subjects that are included in this substudy and that have completed the whole nutritional intervention, 10 subjects (5 from each randomized group) will be selected to microbiota determination.
- Study visits:
- Prescreening visit: Inclusion and exclusion criteria assessment and blood collection if glucose or glycated hemoglobin is not available in previous 3 months. Healthy diet and physical activity counselling is provided by a nutritionist; it should be maintained during all study. Baseline visit is scheduled in 2-4 weeks after lifestyle stabilization.
- Baseline phase 1 visit: Clinical, biochemical, dietary, physical activity and anthropometric data are assessed. Computer-based randomization is performed. Alcohol-free beer (A or B according to randomization procedures) for the next 10 weeks is delivered to the participant who has to consume two per day. A nutritionist emphasizes healthy lifestyle counselling to the participant. A feces sample is collected if subjects accept to be included in microbiota sub study.
- Intermediate phase 1 visit: Clinical, biochemical, dietary, physical activity and anthropometric data are assessed. Satiety after alcohol-free beer consumption is measured by a validated questionnaire. A nutritionist emphasizes healthy lifestyle counselling to the participant.
- End of phase 1 visit: Clinical, biochemical, dietary, physical activity and anthropometric data are assessed. Satiety after alcohol-free beer consumption is measured by a validated questionnaire. A nutritionist emphasizes healthy lifestyle counselling to the participant. A wash-out period of 4-8 weeks is scheduled before the next phase start. A feces sample is collected if subjects accept to be included in microbiota sub study.
- Baseline phase 2 visit: Clinical, biochemical, dietary, physical activity and anthropometric data are assessed. Alcohol-free beer (A or B: if subjects consumed alcohol-free beer A, he/she change to alcohol-free B and vice versa) for the next 10 weeks is delivered to the participant who has to consume two per day. A nutritionist emphasizes healthy lifestyle counselling to the participant. A feces sample is collected if subjects accept to be included in microbiota sub study.
- Intermediate phase 2 visit: Clinical, biochemical, dietary, physical activity and anthropometric data are assessed. Satiety after alcohol-free beer consumption is measured by a validated questionnaire. A nutritionist emphasizes healthy lifestyle counselling to the participant.
- End of phase 2 visit: Clinical, biochemical, dietary, physical activity and anthropometric data are assessed. Satiety after alcohol-free beer consumption is measured by a validated questionnaire. A nutritionist emphasizes healthy lifestyle counselling to the participant. A feces sample is collected if subjects accept to be included in microbiota sub study.
- Study variables:
- Clinical variables: Gender, age, medical records including diseases and medication, tobacco consumption and blood pressure.
- Anthropometric variables: Weight, height, body mass index, waist circumference, body composition analysis.
- Biochemical variables: Glucose, lipid and iron metabolism are assessed. Inflammatory biomarkers, including C reactive protein, are also determined.
- Microbiota: Feces samples are collected to microbiota analysis including Bacteroides, Lactobacillus, Enterococcus, Prevotella or Roseburia, among others.
- Dietary and physical activity assessment: Diet and physical activity are assessed by validated questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol-free beer with regular composition | Active comparator | Other: Alcohol-free beer with regular compositionTwo cans (33 cl.) per day of an alcohol-free beer with regular carbohydrates composition. |
| Alcohol-free beer with modified composition | Experimental | Other: Alcohol-free beer with modified compositionTwo cans (33 cl.) per day of alcohol-free beer with modified carbohydrates composition. This include the substitution of regular maltose by isomaltulose and the addition of maltodextrin (fiber). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 80 years.
- To provide informed consent in writing of voluntary participation in the study after having read the participant information sheet, and having consulted the doubts that may arise from it.
- Diagnosis of prediabetes or diabetes mellitus type 2 defined as: a) fasting glucose ≥ 100 mg/dL in the last 3 months; b) glycated hemoglobin ≥ 5.7% and ≤ 6.5%.
Key exclusion criteria (14 listed)
- Gluten intolerance.
- Taking lipid-lowering drugs.
- Taking antidiabetic drugs, except for metformin in a stable dose in the last 3 months.
- To be under treatment with insulin.
- Presence of uncontrolled endocrinological disease by including hypothyroidism.
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 |
|---|---|---|
| Alcohol-free beer with regular compositionSubjects are provided with 2 alcohol-free beers with regular carbohydrates composition per day and healthy diet counselling during 10 weeks. | Other | Alcohol-free beer with regular composition |
| Alcohol-free beer with modified compositionSubjects are provided with 2 alcohol-free beers with modified carbohydrates composition per day and healthy diet counselling during 10 weeks. | Other | Alcohol-free beer with modified composition |
Primary outcome
Glucose concentration change after each alcohol-free beer phase.
Time frame: 10 weeks
Main objective is to determine the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on glucose concentration change.
Glycated hemoglobin concentration change after each alcohol-free beer phase.
Time frame: 10 weeks
Main objective is to determine the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on glycated hemoglobin concentration change.
Insulin concentration change after each alcohol-free beer phase.
Time frame: 10 weeks
Main objective is to determine the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on insulin concentration change.
Homeostatic model assessment (HOMA) index change after each alcohol-free beer phase.
Time frame: 10 weeks
Main objective is to determine the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on HOMA index change.
4 secondary outcomes
Lipid profile change after each alcohol-free beer phase.
Time frame: 10 weeks
Body weight change after each alcohol-free beer phase.
Time frame: 10 weeks
C reactive protein concentration change after each alcohol-free beer phase.
Time frame: 10 weeks
Micriobota change after each alcohol-free beer phase.
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Derived from this study: PubMed 33900319Mateo-Gallego R , Moreno-Indias I , Bea AM , Sanchez-Alcoholado L , Fumanal AJ , Quesada-Molina M , Prieto-Martin A , Gutierrez-Repiso C , Civeira F , Tinahones FJ . An alcohol-free beer enriched with isomaltulose and a resistant dextrin modulates gut microbiome in subjects with type 2 diabetes mellitus and overweight or obesity: a pilot study. Food Funct. 2021 Apr 21;12(8):3635-3646. doi: 10.1039/d0fo03160g. Epub 2021 Mar 31.
- Derived from this study: PubMed 30879735Mateo-Gallego R, Perez-Calahorra S, Lamiquiz-Moneo I, Marco-Benedi V, Bea AM, Fumanal AJ, Prieto-Martin A, Laclaustra M, Cenarro A, Civeira F. Effect of an alcohol-free beer enriched with isomaltulose and a resistant dextrin on insulin resistance in diabetic patients with overweight or obesity. Clin Nutr. 2020 Feb;39(2):475-483. doi: 10.1016/j.clnu.2019.02.025. Epub 2019 Mar 5.
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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.
Rocio Mateo-Gallego, RD, PhD principal investigator
Aragon Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol-free beer with regular composition and Alcohol-free beer with modified composition in people with Glucose Metabolism Disorders (Including Diabetes Mellitus) and Overweight and Obesity, run by Instituto Aragones de Ciencias de la Salud 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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 9 Nov 2017. 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?
Results are not available in the source record.
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 concentration change after each alcohol-free beer phase. (time frame: 10 weeks). 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?
On the ClinicalTrials.gov record for NCT03337828, which also lists 2 linked publications.
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 9 Nov 2017.