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Innovative Food Structures to Enhance Nutrient Bioavailability (NutriPlus)

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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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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