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Completed

NCT Number: NCT04156074

Innovative Food Structures to Enhance Nutrient Bioavailability

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.

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Key information

Conditions

Vitamin D Deficiency Aging Well Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Dublin

Dublin, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

Vitamin D enriched (20 mcg/day) olive oil emulsion drink. 30 mL drink daily

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

Dietary Supplement

Vitamin D enriched (20 mcg/day) coconut oil emulsion drink 30 mL drink daily

Placebo coconut oil emulsion drink

Dietary Supplement

Placebo coconut oil emulsion drink 30 mL drink daily

Vitamin D supplement (20 mcg/day)

Dietary Supplement

Vitamin D supplement (20 mcg/day) Pill consumed daily

Primary outcomes

  1. Vitamin D status

    Time frame: Baseline to 28 days

    Change in vitamin D status measured as serum 25-hydroxyvitamin D (nmol/L)

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Collaborators

  • Department of Agriculture Food and the Marine

Registry information

Official study title

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

Acronym: NutriPlus

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 7, 2019
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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