Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes (DIABEER)

January 25, 2019 updated by: Universidade do Porto

Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes: A Randomized Controlled Trial

The aim of the study is to investigate the effects of non-alcoholic beer in patients with type 2 diabetes. Subjects will be divided into two groups: the control group, where participants will be consuming a bottle of water (330ml) every day for 12 weeks, and the intervention group, where participants will be consuming a bottle of non-alcoholic beer (330ml) for the same period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a parallel, controlled randomized trial. The study will compare the effect of non-alcoholic beer consumption with water, in patients with type 2 diabetes.

All patients from both groups will receive a personalized nutritional intervention and will be followed throughout the study by a certified nutritionist.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Portugal
      • Lisboa, Portugal, 1169-056
        • Recruiting
        • NOVA Medical School, NOVA University of Lisbon
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women diagnosed with type 2 diabetes mellitus, according to the American Diabetes Association criteria;
  • Ages 40-80 years;
  • Non-smoker;
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Changes in oral glycaemic-control medications in the last 3 months;
  • Subjects with HbA1c levels under 6.4% or above 10%;
  • Subjects under insulinotherapy;
  • Subjects with triglycerides levels above 4.52 nmol/L(400 mg/dL);
  • Intake of antibiotics in the last 12 weeks;
  • Subjects not willing to avoid drinking beer during the study;
  • Subjects with a diagnosis of any digestive disease including functional bowel disorders such as IBS;
  • Pregnant women or women planning to become pregnant during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control Group
Participants will consume a bottle of water (330 ml) every day for 12 weeks.
Dietary supplement: Water
Participants will consume a bottle of water (330 ml) every day for 12 weeks.
Experimental: Non-alcoholic beer
Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.
Dietary supplement: Non-alcoholic beer
Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes in fasting capillary blood glucose from baseline to visit 2 and 3
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Changes in fasting insulin levels from baseline to visit 2 and 3
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Changes in HOMA-IR from baseline to visit 2 and 3
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Changes in HOMA-B from baseline to visit 2 and 3
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Changes in HbA1c levels from baseline to visit 2 and 3
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in intestinal microbiota from baseline to visit 2 and 3
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage.
at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Changes in body mass index from baseline to visit 2 and 3
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Weight and height will be combined to report BMI in kg/m^2
at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Changes in total body fat mass from baseline to visit 2 and 3
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Changes in fasting serum total cholesterol from baseline to visit 2 and 3
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Changes in fasting serum high-density lipoprotein (HDL) cholesterol from baseline to visit 2 and 3
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Changes in fasting serum low-density lipoprotein (LDL) cholesterol from baseline to visit 2 and 3
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Changes in fasting serum triglycerides from baseline to visit 2 and 3
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade do Porto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NOVA Medical School
Center for Health Technology and Services Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DIABEER

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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