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

Diabetes Mellitus, Type 2 Clinical Trial

— DIABEER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03746093
• Other study ID #: DIABEER
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2018
• Est. completion date: December 2019

Study information

• Verified date: October 2018
• Source: Universidade do Porto
• Contact: Conceição Calhau
• Phone: +351218803000
• Email: ccalhau[@]nms.unl.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Water
Participants will consume a bottle of water (330 ml) every day for 12 weeks.
• Non-alcoholic beer
Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.

Locations

Country	Name	City	State
Portugal	NOVA Medical School, NOVA University of Lisbon	Lisboa

Sponsors (3)

Lead Sponsor	Collaborator
Universidade do Porto	Center for Health Technology and Services Research, NOVA Medical School

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)