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| Name | Class |
|---|---|
| Center for Health Technology and Services Research | OTHER |
| NOVA Medical School | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Participants will consume a bottle of water (330 ml) every day for 12 weeks. |
|
| Non-alcoholic beer | Experimental | Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water | Dietary Supplement | Participants will consume a bottle of water (330 ml) every day for 12 weeks. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Conceição Calhau | Contact | +351218803000 | ccalhau@nms.unl.pt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NOVA Medical School, NOVA University of Lisbon | Recruiting | Lisbon | 1169-056 | Portugal |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| Non-alcoholic beer | Dietary Supplement | Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks. |
|
| 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) |
| D004700 | Endocrine System Diseases |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |