Back to resultsEffects of Non-alcoholic Beer in Patients With Type 2 Diabetes (DIABEER)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Water
Non-alcoholic beer
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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.
Sites / Locations
- NOVA Medical School, NOVA University of LisbonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control Group
Non-alcoholic beer
Arm Description
Participants will consume a bottle of water (330 ml) every day for 12 weeks.
Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.
Outcomes
Primary Outcome Measures
Changes in fasting capillary blood glucose from baseline to visit 2 and 3
Changes in fasting insulin levels from baseline to visit 2 and 3
Changes in HOMA-IR from baseline to visit 2 and 3
Changes in HOMA-B from baseline to visit 2 and 3
Changes in HbA1c levels from baseline to visit 2 and 3
Secondary Outcome Measures
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.
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
Changes in total body fat mass from baseline to visit 2 and 3
Changes in fasting serum total cholesterol from baseline to visit 2 and 3
Changes in fasting serum high-density lipoprotein (HDL) cholesterol from baseline to visit 2 and 3
Changes in fasting serum low-density lipoprotein (LDL) cholesterol from baseline to visit 2 and 3
Changes in fasting serum triglycerides from baseline to visit 2 and 3
Full Information
NCT ID
NCT03746093
First Posted
November 15, 2018
Last Updated
January 25, 2019
Sponsor
Universidade do Porto
Collaborators
Center for Health Technology and Services Research, NOVA Medical School
1. Study Identification
Unique Protocol Identification Number
NCT03746093
Brief Title
Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes
Acronym
DIABEER
Official Title
Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 7, 2018 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Porto
Collaborators
Center for Health Technology and Services Research, NOVA Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Participants will consume a bottle of water (330 ml) every day for 12 weeks.
Arm Title
Non-alcoholic beer
Arm Type
Experimental
Arm Description
Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Water
Intervention Description
Participants will consume a bottle of water (330 ml) every day for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Non-alcoholic beer
Intervention Description
Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.
Primary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Secondary Outcome Measure Information:
Title
Changes in intestinal microbiota from baseline to visit 2 and 3
Description
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.
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)
Title
Changes in body mass index from baseline to visit 2 and 3
Description
Weight and height will be combined to report BMI in kg/m^2
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Conceição Calhau
Phone
+351218803000
Email
ccalhau@nms.unl.pt
Facility Information:
Facility Name
NOVA Medical School, NOVA University of Lisbon
City
Lisboa
ZIP/Postal Code
1169-056
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Conceição Calhau
Phone
00351918482491
Email
diabeer@nms.unl.pt
12. IPD Sharing Statement
Learn more about this trial
Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes
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