Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DIETARY_SUPPLEMENTWater
Participants will consume a bottle of water (330 ml) every day for 12 weeks.
DIETARY_SUPPLEMENTNon-alcoholic beer
Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.
Sponsors
Center for Health Technology and Services Research
NOVA Medical School
Universidade do Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HOMA-B from baseline to visit 2 and 3 | 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 capillary blood glucose from baseline to visit 2 and 3 | 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 | 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 | 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 | at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in fasting serum high-density lipoprotein (HDL) cholesterol from baseline to visit 2 and 3 | 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 | 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 | 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 intestinal microbiota from baseline to visit 2 and 3 | 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. |
| Changes in body mass index from baseline to visit 2 and 3 | 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 |
| Changes in total body fat mass from baseline to visit 2 and 3 | 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 | at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period) | — |
Countries
Portugal
Contacts
Primary ContactConceição Calhau
Outcome results
None listed