Innovative Food Structures to Enhance Nutrient Bioavailability (NutriPlus)

University College Dublin

Status: Completed

Conditions: Vitamin D Deficiency; Aging Well

Treatments: Dietary Supplement: Vitamin D enriched (20 mcg/day) olive oil emulsion drink; Dietary Supplement: Placebo coconut oil emulsion drink; Dietary Supplement: Vitamin D supplement (20 mcg/day); Dietary Supplement: Vitamin D enriched (20 mcg/day) coconut oil emulsion drink

Study type: Interventional

Funder types: Other

Identifiers

NCT04156074

LS-19-56-McCourt-OSullivan

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

Vitamin D enriched (20 mcg/day) olive oil emulsion drink

Experimental group

Description:

30 mL vitamin D enriched drink consumed daily for 4 weeks

Treatment:

Dietary Supplement: Vitamin D enriched (20 mcg/day) olive oil emulsion drink

Vitamin D enriched (20 mcg/day) coconut oil emulsion drink

Active Comparator group

Description:

30 mL vitamin D enriched drink consumed daily for 4 weeks

Treatment:

Dietary Supplement: Vitamin D enriched (20 mcg/day) coconut oil emulsion drink

Placebo coconut oil emulsion drink

Placebo Comparator group

Description:

30 mL placebo drink consumed daily for 4 weeks

Treatment:

Dietary Supplement: Placebo coconut oil emulsion drink

Vitamin D supplement (20 mcg/day)

Active Comparator group

Description:

Vitamin D supplement consumed daily for 4 weeks

Treatment:

Dietary Supplement: Vitamin D supplement (20 mcg/day)