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

Study Overview
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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.

Official Title
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Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes: A Randomized Controlled Trial

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: Water
* Dietary Supplement: Non-alcoholic beer


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Participants will consume a bottle of water (330 ml) every day for 12 weeks. | Dietary Supplement: Water<br>* Participants will consume a bottle of water (330 ml) every day for 12 weeks.<br>|
| Experimental: Non-alcoholic beer<br>Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks. | Dietary Supplement: Non-alcoholic beer<br>* Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 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) | 
| 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 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 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) |