The Difference in Health Outcomes After Drinking Cow's Milk Compared to Oat Milk - a Pilot Randomized Controlled Study
1 other identifier
interventional
32
1 country
1
Brief Summary
A new dietary trend is switching from cow\'s milk to plant-based milk alternatives, driven by the belief that this switch is beneficial for health reasons in addition to the sustainability aspect of a plant-based diet. The trend of using plant-based milk alternatives is especially popular among young women, of whom iodine nutrition also is of concern, both globally and in Norway. Some of the plant-based alternatives are fortified with iodine, but both the bio-availability and whether is feasible to consume large enough amounts of the milk to provide an adequate iodine intake is unknown. Another aspect is that the effect of cow's milk intake on blood lipids has been widely studied, however, there is a lack of studies on the effect of oat milk consumption on blood lipids.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedFirst Submitted
Initial submission to the registry
January 2, 2025
CompletedFirst Posted
Study publicly available on registry
January 8, 2025
CompletedJanuary 8, 2025
June 1, 2024
3 months
January 2, 2025
January 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Iodine nutrition
24-hr urine collection, 2 x spot urine, TSH, fT4, fT3, dietary iodine intake by 24-hour recall interview
Basline and end of intervention after 4 weeks
Blood lipids
s-HDL, s-LDL, s-total cholesterol, s-triacylglyserol
Basline and end of intervention after 4 weeks
Secondary Outcomes (2)
Body weight
Basline and end of intervention after 4 weeks
Hydration status
Basline and end of intervention after 4 weeks
Study Arms (2)
Cow's milk
ACTIVE COMPARATOR6 dl of cow's milk daily
Oat drink
EXPERIMENTAL6 dl of Oat drink daily
Interventions
Eligibility Criteria
You may qualify if:
- women aged 18-40 years
- healthy
- habitual milk drinkers
You may not qualify if:
- pregnant or lactating
- known thyroid disease
- planning to conceive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bergenlead
- Institute of Marine Researchcollaborator
Study Sites (1)
Research Unit for Health Surveys
Bergen, 5021, Norway
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hanne Rosendahl-Riise, PhD
University of Bergen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2025
First Posted
January 8, 2025
Study Start
August 20, 2024
Primary Completion
November 30, 2024
Study Completion
November 30, 2024
Last Updated
January 8, 2025
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share
This is a pilot study with limited number of participants.