- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03746093
Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes (DIABEER)
January 25, 2019 updated by: Universidade do Porto
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Conceição Calhau
- Phone Number: +351218803000
- Email: ccalhau@nms.unl.pt
Study Locations
-
-
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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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
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.
|
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
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
|
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
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
|
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
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
|
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
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
|
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
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
|
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
Time Frame: 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.
|
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
Time Frame: 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
|
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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Changes in total body fat mass from baseline to visit 2 and 3
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
|
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
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
|
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
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
|
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
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
|
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
Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period)
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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