NCT07131904

Brief Summary

This study examines how various non-alcoholic beverages affect blood sugar levels. The beverages are a non-alcoholic, fiber-enriched beer, a conventional non-alcoholic beer, and a sugar solution. Participants drink one of these beverages on different days. Afterwards, a sensor on the upper arm is used to measure the sugar content in the body fluid under the skin over a period of two hours. The aim is to find out how much blood sugar concentration rises after drinking. This will be used to check whether the non-alcoholic, fiber-enriched beer has a more favorable effect on sugar metabolism than conventional beverages. Participation is voluntary, and the data will be treated confidentially.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

August 12, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

August 13, 2025

Last Update Submit

August 13, 2025

Conditions

Keywords

fiber-enriched beerfunctional foodcontinuous glucose monitoringpostprandial glucose response

Outcome Measures

Primary Outcomes (1)

  • Incremental Area Under the Curve (iAUC) for Postprandial Blood Glucose

    Incremental area under the curve for interstitial glucose concentration measured over 120 minutes after beverage consumption. Measurements obtained via continuous glucose monitoring (FreeStyle Libre 3) in a randomized crossover design.

    0-120 minutes after beverage consumption on each test day

Secondary Outcomes (1)

  • Glycemic Index of Fiber-Enriched Beer (FEB)

    0-120 minutes after beverage consumption on each test day

Study Arms (3)

non-alcoholic, fiber-enriched beer (FEB)

EXPERIMENTAL
Other: non-alcoholic, fiber-enriched beer (FEB)

conventional, non-alcoholic beer

ACTIVE COMPARATOR
Other: conventional, non-alcoholic beer

glucose solution

ACTIVE COMPARATOR
Other: glucose solution

Interventions

500 ml FEB consumed once during a test day in a randomized crossover design. Postprandial blood glucose is monitored for 120 minutes using a continuous glucose monitor (FreeStyle Libre 3).

non-alcoholic, fiber-enriched beer (FEB)

500 ml conventional non-alcoholic beer consumed once during a test day in a randomized crossover design. Postprandial blood glucose is monitored for 120 minutes using a continuous glucose monitor (FreeStyle Libre 3).

conventional, non-alcoholic beer

Glucose solution containing 12.5 g glucose in 500 ml water, consumed once during a test day in a randomized crossover design. Postprandial blood glucose is monitored for 120 minutes using a continuous glucose monitor (FreeStyle Libre 3).

glucose solution

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 18-60 years
  • Body mass index (BMI) between 18.5 and 29.9 kg/m²
  • Signed informed consent

You may not qualify if:

  • Diagnosed diabetes
  • Gastrointestinal diseases
  • Hormonal or other metabolic diseases
  • Allergies or intolerances to beer ingredients
  • Professional sports (\>10 hours/week of intense exercise)
  • Special diets (e.g., low-carb, intermittent fasting)
  • Sleep disorders or inability to maintain regular sleep (e.g., shift work)
  • Pregnancy or breastfeeding
  • Smoking
  • Inability to speak German or English
  • Problems with alcohol, drug, or medication abuse
  • Inability to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Congresses as Topic

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Central Study Contacts

David Fäh, Prof.Dr.med

CONTACT

Neeser Lorena, Bsc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med. David Fäh

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 20, 2025

Study Start

August 12, 2025

Primary Completion

September 22, 2025

Study Completion

October 15, 2025

Last Updated

August 20, 2025

Record last verified: 2025-08