Innovative Food Structures to Enhance Nutrient Bioavailability

Study Overview
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Brief Summary
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This randomized controlled trial (RCT) will compare the change in vitamin D status (25-hydroxyvitamin D nmol/L) after a 4 week intervention with 4 groups: Vitamin D enriched (20ug) olive oil emulsion drink Vitamin D enriched (20ug) coconut oil emulsion drink Placebo emulsion drink Vitamin D supplement (20ug) Participants will be randomized to 1 of 4 intervention group. Hypothesis 1: 25-hydroxyvitamin D concentrations are higher in the olive oil emulsion drink group compared to the placebo emulsion drink group post intervention. Hypothesis 2: 25-hydroxyvitamin D concentrations are higher in the olive oil emulsion drink group compared to the coconut oil emulsion drink group post intervention.

Official Title
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Innovative Food Structures to Enhance the Sensory Experience, the Nutrient Profile and Nutrient Bioavailability for Older People

Conditions
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Vitamin D Deficiency, Aging Well

Intervention / Treatment
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* Dietary Supplement: Vitamin D enriched (20 mcg/day) olive oil emulsion drink
* Dietary Supplement: Vitamin D enriched (20 mcg/day) coconut oil emulsion drink
* Dietary Supplement: Placebo coconut oil emulsion drink
* Dietary Supplement: Vitamin D supplement (20 mcg/day)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Healthy adults Exclusion Criteria: Pregnant/lactating Smokers Individuals who are not free-living An inability to read, write or understand English Following a strict diet for any reason, insulin dependent diabetes, coeliac etc. Disease that requires chronic therapeutic nutritional or medical treatment Those with conditions that may affect kidney function Those with osteoporosis Those taking supplemental vitamin D Those who have been on a sun holiday in the last 2 months Those with a milk protein allergy or lactose intolerance

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Randomized Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D enriched (20 mcg/day) olive oil emulsion drink<br>30 mL vitamin D enriched drink consumed daily for 4 weeks | Dietary Supplement: Vitamin D enriched (20 mcg/day) olive oil emulsion drink<br>* Vitamin D enriched (20 mcg/day) olive oil emulsion drink. 30 mL drink daily<br>|
| Active Comparator: Vitamin D enriched (20 mcg/day) coconut oil emulsion drink<br>30 mL vitamin D enriched drink consumed daily for 4 weeks | Dietary Supplement: Vitamin D enriched (20 mcg/day) coconut oil emulsion drink<br>* Vitamin D enriched (20 mcg/day) coconut oil emulsion drink 30 mL drink daily<br>|
| Placebo Comparator: Placebo coconut oil emulsion drink<br>30 mL placebo drink consumed daily for 4 weeks | Dietary Supplement: Placebo coconut oil emulsion drink<br>* Placebo coconut oil emulsion drink 30 mL drink daily<br>|
| Active Comparator: Vitamin D supplement (20 mcg/day)<br>Vitamin D supplement consumed daily for 4 weeks | Dietary Supplement: Vitamin D supplement (20 mcg/day)<br>* Vitamin D supplement (20 mcg/day) Pill consumed daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D status | Change in vitamin D status measured as serum 25-hydroxyvitamin D (nmol/L) | Baseline to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Bioavailability, Aging, Fortified foods, Vitamin D status, 25-hydroxyvitamin D