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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants will consume a bottle of water (330 ml) every day for 12 weeks.
Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.
NOVA Medical School, NOVA University of Lisbon
Lisbon, Portugal
RECRUITINGChanges 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)
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)
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)
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)
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)
Changes in intestinal microbiota from baseline to visit 2 and 3
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.
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)
Changes in body mass index from baseline to visit 2 and 3
Weight and height will be combined to report BMI in kg/m\^2
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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)
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)
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)
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)
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)