NCT06764173

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

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
Last Updated

January 8, 2025

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

January 2, 2025

Last Update Submit

January 2, 2025

Conditions

Keywords

Iodine nutrition statusBlood lipidsoat milk

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 COMPARATOR

6 dl of cow's milk daily

Other: Oat drinkOther: Cow's milk

Oat drink

EXPERIMENTAL

6 dl of Oat drink daily

Other: Oat drinkOther: Cow's milk

Interventions

6 dl of oat drink daily

Cow's milkOat drink

6 dl of cow's milk daily

Cow's milkOat drink

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Research Unit for Health Surveys

Bergen, 5021, Norway

Location

MeSH Terms

Interventions

Milk

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Hanne Rosendahl-Riise, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

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.

Locations