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

Universidade do Porto

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: Non-alcoholic beer; Dietary Supplement: Water

Study type: Interventional

Funder types: Other

Identifiers

NCT03746093

DIABEER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Water

Non-alcoholic beer

Experimental group

Description:

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

Treatment:

Dietary Supplement: Non-alcoholic beer