Status unknownNCT03337828Updated Nov 9, 2017

Effect of Two Alcohol-free Beers With Different Carbohydrates Composition on Lipids and Glucose Metabolism

An interventional study of Alcohol-free beer with regular composition and Alcohol-free beer with modified composition in Glucose Metabolism Disorders (Including Diabetes Mellitus) and Overweight and Obesity, sponsored by Instituto Aragones de Ciencias de la Salud. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-09.

Sponsored by Instituto Aragones de Ciencias de la Salud · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

Registered 7 months after the study started (first participant enrolled Mar 2017, registered Oct 2017).

Phase: Not applicable
Study type: Interventional
Enrollment: 44
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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 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:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.

Conditions studied

Glucose Metabolism Disorders (Including Diabetes Mellitus)
Overweight and Obesity

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Keywords

Alcohol-free beer
Carbohydrates
Overweight
Obesity
Diabetes mellitus type 2
Microbiota
Glucose metabolism

In context

Glucose Metabolism Disorders

361 studies on the registry are indexed under Glucose Metabolism Disorders; 38 are open to participants now.

This study's planned enrollment of 44 is below the median of 60 across 308 interventional studies indexed under Glucose Metabolism Disorders.

Browse Glucose Metabolism Disorders studies →

Lead sponsor

Instituto Aragones de Ciencias de la Salud is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Aged between 18 and 80 years.
To provide 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) ≥ 5.7% and ≤ 6.5%.

Exclusion criteria

Exclusion Criteria:

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.
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 or if, in the opinion of the investigators, it would limit a stable diet throughout the study.
To be under treatment with , 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.).

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 44 participants (estimated)

Study arms

Active comparator
Alcohol-free beer with regular composition
Two cans (33 cl.) per day of an alcohol-free beer with regular carbohydrates composition.
Other: Alcohol-free beer with regular composition
Experimental
Alcohol-free beer with modified composition
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).
Other: Alcohol-free beer with modified composition

Interventions

OtherAlcohol-free beer with regular composition
Subjects are provided with 2 alcohol-free beers with regular carbohydrates composition per day and healthy diet counselling during 10 weeks.
OtherAlcohol-free beer with modified composition
Subjects are provided with 2 alcohol-free beers with modified carbohydrates composition per day and healthy diet counselling during 10 weeks.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 weeks

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 weeks

Study locations

1 site

Fernando Civeira
Zaragoza, 50009, Spain

References and documents

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 33900319 ↗
Mateo-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 documents

Protocol and statistical analysis plan ↗ · Nov 8, 2017

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2017 (actual). Primary completion is estimated for Dec 2017, 9 months after the start.

Of 106 non-industry interventional studies with no phase under Glucose Metabolism Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 40. This study's planned 9 months is below that.

Counting every sponsor, half of 119 studies reached it within 19 months; a quarter within 7 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 31, 2017
First posted: Nov 9, 2017
StartActual: Mar 1, 2017
Primary completionEst.: Dec 2017
CompletionEst.: Dec 2017
Last update: Nov 9, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03337828
Lead sponsor: Instituto Aragones de Ciencias de la Salud
Collaborators: Aragon Institute of Health Sciences
Responsible party: Fernando Civeira (Professor of Medicine, Aragon Institute of Health Sciences) — Principal investigator
First posted: Nov 9, 2017
Start date: Mar 1, 2017
Primary completion: Dec 2017 (estimated)
Completion: Dec 2017 (estimated)
Last update: Nov 9, 2017

Study contacts

Rocio Mateo-Gallego, RD, PhD

principal investigator · Aragon Institute of Health Sciences

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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