- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07730229
Study the Effect of Plant-based Beverage Consumption on the Gut Microbiome in Healthy Adults
July 23, 2026 updated by: Åsa Håkansson, Lund University
Analysis of the Intestinal Flora Composition After Consumption of Plant-based Beverages
The goal of this intervention study is to analyse the microbiota composition after the plant-based beverage consumption.
The main questions are to evaluate if the plant-based beverage can have a beneficial effect on the gut microbiota.
Participants will consume different plant-based beverages for two weeks, and microbiota will be analysed.
Researchers will compare the microbiota composition before and after consumption.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
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 Locations
-
-
Skåne County
-
Lund, Skåne County, Sweden, 22100
- Recruiting
- Lund University
-
Contact:
- Åsa Håkansson, PhD
- Phone Number: +46704566277
- Email: asa.hakansson@ple.lth.se
-
Contact:
- Rumathi de Mel, Masters
- Phone Number: +46737464561
- Email: rumathi.de_mel@ple.lth.se
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18-65 years of age. • must be able to complete the form digitally.
Exclusion Criteria:
- Must not be diagnosed with gastrointestinal diseases, autoimmune diseases or have diseases or medications that cause immune deficiency, such as MS, type 1 diabetes, cancer or HIV
- must not take antibiotics during the study period
- must not have a milk protein allergy
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active group
Participants will consume the assigned dairy milk for two weeks.
|
Participants will consume the assigned plant-based beverages for two weeks.
|
|
Experimental: Experimental group
Participants will consume the assigned plant-based beverages for two weeks.
|
Participants will consume the assigned plant-based beverages for two weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in gut microbiome alpha diversity
Time Frame: up to 24 weeks
|
Gut microbiome alpha diversity will be assessed using 16S rRNA gene sequencing and quantified using alpha diversity indices (e.g., Shannon diversity index).
|
up to 24 weeks
|
|
Change in gut microbiome beta diversity
Time Frame: Upto 24 weeks
|
Gut microbiome beta diversity will be assessed using 16S rRNA gene sequencing by comparing community composition between samples using beta diversity distance metrics (e.g., Bray-Curtis dissimilarity or UniFrac distances).
|
Upto 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the relative abundance of gut bacterial taxa
Time Frame: Baseline to Week 24
|
The relative abundance of bacterial taxa identified by 16S rRNA gene sequencing will be compared between study groups and over time.
|
Baseline to Week 24
|
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 10, 2025
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
July 31, 2026
Study Registration Dates
First Submitted
June 29, 2026
First Submitted That Met QC Criteria
July 23, 2026
First Posted (Actual)
July 28, 2026
Study Record Updates
Last Update Posted (Actual)
July 28, 2026
Last Update Submitted That Met QC Criteria
July 23, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- Plant-based beverages
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.