NCT03746093

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 29, 2019

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

November 15, 2018

Last Update Submit

January 25, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (7)

  • 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)

  • 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)

  • 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)

  • +2 more secondary outcomes

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Participants will consume a bottle of water (330 ml) every day for 12 weeks.

Dietary Supplement: Water

Non-alcoholic beer

EXPERIMENTAL

Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.

Dietary Supplement: Non-alcoholic beer

Interventions

WaterDIETARY_SUPPLEMENT

Participants will consume a bottle of water (330 ml) every day for 12 weeks.

Control Group
Non-alcoholic beerDIETARY_SUPPLEMENT

Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.

Non-alcoholic beer

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NOVA Medical School, NOVA University of Lisbon

Lisbon, 1169-056, Portugal

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Water

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Central Study Contacts

Conceição Calhau

CONTACT

+351218803000ccalhau@nms.unl.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 19, 2018

Study Start

November 7, 2018

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

January 29, 2019

Record last verified: 2018-10

Locations

PT(1)