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

Not Applicable

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Water; Dietary Supplement: Non-alcoholic beer

• Registration Number: NCT03746093
• Lead Sponsor: Universidade do Porto

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.

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-11-07
• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-19
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-29
• Primary Completion: 2019-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Water	Participants will consume a bottle of water (330 ml) every day for 12 weeks.
Non-alcoholic beer	Non-alcoholic beer	Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 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-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

Name	Time	Method
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 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 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 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 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 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 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)

Trial Locations

Locations (1)

NOVA Medical School, NOVA University of Lisbon; 🇵🇹 Lisboa, Portugal