Clinical trial NCT03746093: Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes
Official title: Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Center for Health Technology and Services Research
name: NOVA Medical School
First posted: 2018-11-19
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in fasting capillary blood glucose from baseline to visit 2 and 3
timeFrame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
measure: Changes in fasting insulin levels from baseline to visit 2 and 3
timeFrame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
measure: Changes in HOMA-IR from baseline to visit 2 and 3
timeFrame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
measure: Changes in HOMA-B from baseline to visit 2 and 3
timeFrame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
measure: Changes in HbA1c levels from baseline to visit 2 and 3
timeFrame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Secondary outcomes:
measure: Changes in intestinal microbiota from baseline to visit 2 and 3
timeFrame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
measure: Changes in body mass index from baseline to visit 2 and 3
timeFrame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
measure: Changes in total body fat mass from baseline to visit 2 and 3
timeFrame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
measure: Changes in fasting serum total cholesterol from baseline to visit 2 and 3
timeFrame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
measure: Changes in fasting serum high-density lipoprotein (HDL) cholesterol from baseline to visit 2 and 3
timeFrame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
measure: Changes in fasting serum low-density lipoprotein (LDL) cholesterol from baseline to visit 2 and 3
timeFrame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
measure: Changes in fasting serum triglycerides from baseline to visit 2 and 3
timeFrame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: NOVA Medical School, NOVA University of Lisbon
Study officials:
References: