Innovative Food Structures to Enhance Nutrient Bioavailability (NutriPlus)

March 3, 2023 updated by: Aifric O'Sullivan, University College Dublin

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • University College Dublin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D status
Time Frame: Baseline to 28 days
Change in vitamin D status measured as serum 25-hydroxyvitamin D (nmol/L)
Baseline to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Dublin

Collaborators

Department of Agriculture Food and the Marine

Investigators

  • Principal Investigator: Aifric O'Sullivan, PhD, University College Dublin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2019

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

November 5, 2019

First Submitted That Met QC Criteria

November 6, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LS-19-56-McCourt-OSullivan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin D Deficiency

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe