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

NCT ID: NCT03746093

Last Updated: 2019-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-07

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Participants will consume a bottle of water (330 ml) every day for 12 weeks.

Group Type PLACEBO_COMPARATOR

Water

Intervention Type DIETARY_SUPPLEMENT

Participants will consume a bottle of water (330 ml) every day for 12 weeks.

Non-alcoholic beer

Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.

Group Type EXPERIMENTAL

Non-alcoholic beer

Intervention Type DIETARY_SUPPLEMENT

Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.

Interventions

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Water

Participants will consume a bottle of water (330 ml) every day for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Non-alcoholic beer

Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center for Health Technology and Services Research

OTHER

Sponsor Role collaborator

NOVA Medical School

OTHER

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NOVA Medical School, NOVA University of Lisbon

Lisbon, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Conceição Calhau

Role: CONTACT

+351218803000

Facility Contacts

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Conceição Calhau

Role: primary

00351918482491

Other Identifiers

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DIABEER

Identifier Type: -

Identifier Source: org_study_id

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