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Innovative Food Structures to Enhance Nutrient Bioavailability (NutriPlus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04156074
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Department of Agriculture Food and the Marine
Information provided by (Responsible Party):
Aifric O'Sullivan, 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.


Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Aging Well 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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Randomized Controlled Trial
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Prevention
Official Title: Innovative Food Structures to Enhance the Sensory Experience, the Nutrient Profile and Nutrient Bioavailability for Older People
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D enriched (20 mcg/day) olive oil emulsion drink
30 mL vitamin D enriched drink consumed daily for 4 weeks
Dietary Supplement: Vitamin D enriched (20 mcg/day) olive oil emulsion drink
Vitamin D enriched (20 mcg/day) olive oil emulsion drink. 30 mL drink daily

Active Comparator: Vitamin D enriched (20 mcg/day) coconut oil emulsion drink
30 mL vitamin D enriched drink consumed daily for 4 weeks
Dietary Supplement: Vitamin D enriched (20 mcg/day) coconut oil emulsion drink
Vitamin D enriched (20 mcg/day) coconut oil emulsion drink 30 mL drink daily

Placebo Comparator: Placebo coconut oil emulsion drink
30 mL placebo drink consumed daily for 4 weeks
Dietary Supplement: Placebo coconut oil emulsion drink
Placebo coconut oil emulsion drink 30 mL drink daily

Active Comparator: Vitamin D supplement (20 mcg/day)
Vitamin D supplement consumed daily for 4 weeks
Dietary Supplement: Vitamin D supplement (20 mcg/day)
Vitamin D supplement (20 mcg/day) Pill consumed daily




Primary Outcome Measures :
  1. Vitamin D status [ Time Frame: Baseline to 28 days ]
    Change in vitamin D status measured as serum 25-hydroxyvitamin D (nmol/L)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156074


Contacts
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Contact: Aifric O'Sullivan, PhD +353 1 7162824 aifric.osullivan@ucd.ie
Contact: Aislinn McCourt, BSc +353 1 7162824 aislinn.mccourt@ucd.ie

Locations
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Ireland
University College Dublin Recruiting
Dublin, Ireland
Contact: Aifric O'Sullivan, PhD    +353 1 7162824    aifric.osullivan@ucd.ie   
Sponsors and Collaborators
University College Dublin
Department of Agriculture Food and the Marine
Investigators
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Principal Investigator: Aifric O'Sullivan, PhD University College Dublin

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Responsible Party: Aifric O'Sullivan, Assistant Professor, University College Dublin
ClinicalTrials.gov Identifier: NCT04156074    
Other Study ID Numbers: LS-19-56-McCourt-OSullivan
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aifric O'Sullivan, University College Dublin:
Vitamin D
Bioavailability
Aging
Fortified foods
Vitamin D status
25-hydroxyvitamin D
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Nutrients
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents