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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: Water; Dietary supplement: Non-alcoholic beer

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal, 1169-056
    • Recruiting
    • NOVA Medical School, NOVA University of Lisbon
    • Contact: Conceição Calhau; Phone Number: 00351918482491; Email: diabeer@nms.unl.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: NOVA Medical School; Center for Health Technology and Services Research

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DIABEER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No