The Difference in Health Outcomes After Drinking Cow's Milk Compared to Oat Milk - a Pilot Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Bergen
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Iodine nutrition
Study Overview
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.
Detailed Description
The aim of this study is two-fold
- To compare the iodine nutrition in those drinking cow's milk compared to oat milk
- To compare the levels of blood lipids in those drinking cow's milk compared to oat milk
Recruitment Women aged 18-40 years deemed eligible according to the inclusion and exclusion criteria will be asked to participate in the study. The recruitment will occur at the University of Bergen during the fall of 2024. Those willing to participate will contact the study personal by a digital form. Before participation, signed informed consent must be provided.
Participants who uses dietary supplements will be asked to cease these during the intervention. The exception is those with clinical deficiency e.g. anemia.
Sample size This is a pilot study testing both the feasibility of the interventions and if we observe any changes in the outcomes. To our knowledge, no trials have been conducted comparing cow's milk and oat milk before. Hypothesizing that oat milk will decrease total cholesterol due to its content of beta-glucans and a higher content of PUFAS compared to cow's milk. For the cow's milk group, we expect the total cholesterol in the cow's milk group to stay the same before and after intervention. A mean difference of 0.6 mmol/l between the groups, will need groups of 174 with an alpha of 0.05 and power of 80%. Due to the limitations and time frame of a master thesis, we propose 15 persons per arm, thus including 30-40 participants. In our experience with similar intervention studies in the same group of participants, this sample size is feasible within the timeframe of a master's thesis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •women aged 18-40 years
- •habitual milk drinkers
Exclusion Criteria
- •pregnant or lactating
- •known thyroid disease
- •planning to conceive
Outcomes
Primary Outcomes
Iodine nutrition
Time Frame: Basline and end of intervention after 4 weeks
24-hr urine collection, 2 x spot urine, TSH, fT4, fT3, dietary iodine intake by 24-hour recall interview
Blood lipids
Time Frame: Basline and end of intervention after 4 weeks
s-HDL, s-LDL, s-total cholesterol, s-triacylglyserol
Secondary Outcomes
- Body weight(Basline and end of intervention after 4 weeks)
- Hydration status(Basline and end of intervention after 4 weeks)