Innovative Food Structures to Enhance Nutrient Bioavailability

Not Applicable

Completed

• Conditions: Aging Well; Vitamin D Deficiency
• Interventions: Dietary Supplement: Vitamin D supplement (20 mcg/day); Dietary Supplement: Vitamin D enriched (20 mcg/day) olive oil emulsion drink; Dietary Supplement: Placebo coconut oil emulsion drink; Dietary Supplement: Vitamin D enriched (20 mcg/day) coconut oil emulsion drink

• Registration Number: NCT04156074
• Lead Sponsor: University College Dublin

Brief Summary

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:

1. Vitamin D enriched (20ug) olive oil emulsion drink

2. Vitamin D enriched (20ug) coconut oil emulsion drink

3. Placebo emulsion drink

4. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-04
• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-07
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-03
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D supplement (20 mcg/day)	Vitamin D supplement (20 mcg/day)	Vitamin D supplement consumed daily for 4 weeks
Vitamin D enriched (20 mcg/day) olive oil emulsion drink	Vitamin D enriched (20 mcg/day) olive oil emulsion drink	30 mL vitamin D enriched drink consumed daily for 4 weeks
Placebo coconut oil emulsion drink	Placebo coconut oil emulsion drink	30 mL placebo drink consumed daily for 4 weeks
Vitamin D enriched (20 mcg/day) coconut oil emulsion drink	Vitamin D enriched (20 mcg/day) coconut oil emulsion drink	30 mL vitamin D enriched drink consumed daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Vitamin D status	Baseline to 28 days	Change in vitamin D status measured as serum 25-hydroxyvitamin D (nmol/L)

Trial Locations

Locations (1)

University College Dublin; 🇮🇪 Dublin, Ireland