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Vitamin D Enriched Meat Project (Acute Study)

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pork arm
Chicken arm
Sponsored by
University of Ulster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin D Deficiency focused on measuring Vitamin D, Pork, Chicken, Bioavailability, 25 hydroxyvitamin D, Adults, RCT, Crossover

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • · Free-living, apparently healthy Caucasian adults

    • Aged 18-65 years at Recruitment
    • Body Mass Index (BMI) ≥18.5 and <25kg/m2
    • If consuming vitamin D supplements, willing to discontinue 4 weeks prior and for duration of study
    • Non-smokers

Exclusion Criteria:

  • · Non-Caucasian adults

    • Adults <18 or >65 years at recruitment
    • Taking vitamin D supplement and not willing to discontinue vitamin D supplementation for 4 weeks prior to and for duration of study
    • Current smokers
    • Pregnant/lactating females
    • Use of tanning facilities or winter vacation planned during the intervention period to a location expected to increase cutaneous synthesis
    • Severe medical illness
    • Medications which interfere with vitamin D metabolism e.g. steroid medications (e.g. prednisone), weight loss drug orlistat (e.g. Xenical and Alli), cholesterol-lowering drug cholestyramine (e.g. Questran, LoCholest and Prevalite), seizure drugs Phenobarbital and Dilantin, anti-tuberculosis, statins or thiazide diuretics
    • Intestinal malabsorption syndrome
    • Excessive alcohol use (>14 units/ week)

Sites / Locations

  • Human Intervention Studies Unit, Ulster University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Active Comparator

Experimental

Placebo Comparator

Arm Label

Vitamin D-enriched pork

Control pork

Vitamin D supplement

Vitamin D-enriched chicken

Control chicken

Arm Description

One portion of Vitamin D-enriched pork

One portion of control pork

Equivocal dose of Vitamin D supplement

One portion of Vitamin D-enriched chicken

One portion of control chicken

Outcomes

Primary Outcome Measures

Change in vitamin D concentration
Vitamin D3, vitamin D2, 25(OH)D3, 25(OH)D2) (nmol/L) in serum/plasma

Secondary Outcome Measures

Calcium serum concentrations
Adjusted calcium
Parathyroid hormone (PTH) concentration
Plasma levels

Full Information

First Posted
December 18, 2019
Last Updated
June 11, 2021
Sponsor
University of Ulster
Collaborators
Devenish Nutrition, Lagan House, 19 Clarendon Road, Belfast, BT1 3BG, Agri-Food and Biosciences Institute (AFBI), 18a Newforge Lane, Belfast, BT9 5P
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1. Study Identification

Unique Protocol Identification Number
NCT04207294
Brief Title
Vitamin D Enriched Meat Project (Acute Study)
Official Title
Bioavailability of Vitamin D-enriched Pork and Chicken in Comparison to a Vitamin D Supplement in Healthy Adults: an Acute Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
April 10, 2020 (Actual)
Study Completion Date
April 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ulster
Collaborators
Devenish Nutrition, Lagan House, 19 Clarendon Road, Belfast, BT1 3BG, Agri-Food and Biosciences Institute (AFBI), 18a Newforge Lane, Belfast, BT9 5P

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The importance of achieving an adequate vitamin D status is widely recognised, with public health and research communities heightening their interest over recent years. Whilst vitamin D can be synthesised following skin exposure to UV light, due to public health concerns regarding sun safety, and modern indoor lifestyles, it has become evident that endogenous synthesis may not be an effective means of maintaining an adequate vitamin D status across the year. Given the marked variation in seasonally-induced cutaneous synthesis, habitually low dietary vitamin D intakes of 2-4µg/day typically reported within nationally represented population surveys, and the generally low uptake of supplementation at the population level, it is warranted to identify alternative food-based strategies to yield greater adherence to the 10µg DRV, particularly during winter months where sunlight exposure is negligible. Commodity-based biofortification may provide an innovative and viable additional food-based approach to suboptimal vitamin D status, in combination with safe sun exposure, inclusion of natural and fortified dietary sources and/or supplementation. Meat naturally contains vitamin D3 and 25(OH)D3, yet by manipulating feeding regimes and/ or housing environments, it is possible to improve the concentration of both metabolites in animal products. Eggs, beef and pork provide viable opportunities for the enhancement of vitamin D3 and 25(OH)D3 which contribute to an increase in total vitamin D activity (vitamin D3 + [25(OH)D3 x 5]), and therefore would be expected to positively impact vitamin D status. Albeit whilst much biofortification research has been established, less is known regarding its effectiveness at raising circulating serum 25(OH)D concentrations amongst apparently healthy adults, with the exception of some plant-based foods. Therefore, an opportunity exists to understand the bioavailability of vitamin D-enriched pork and vitamin D-enriched chicken to increase 25(OH)D concentration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Vitamin D, Pork, Chicken, Bioavailability, 25 hydroxyvitamin D, Adults, RCT, Crossover

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D-enriched pork
Arm Type
Experimental
Arm Description
One portion of Vitamin D-enriched pork
Arm Title
Control pork
Arm Type
Placebo Comparator
Arm Description
One portion of control pork
Arm Title
Vitamin D supplement
Arm Type
Active Comparator
Arm Description
Equivocal dose of Vitamin D supplement
Arm Title
Vitamin D-enriched chicken
Arm Type
Experimental
Arm Description
One portion of Vitamin D-enriched chicken
Arm Title
Control chicken
Arm Type
Placebo Comparator
Arm Description
One portion of control chicken
Intervention Type
Other
Intervention Name(s)
Pork arm
Intervention Description
The effect of 1 portion of vitamin D-enriched pork on 25(OH)D concentration in comparison to a vitamin D supplement and control pork.
Intervention Type
Other
Intervention Name(s)
Chicken arm
Intervention Description
The effect of 1 portion of vitamin D-enriched chicken on 25(OH)D concentration in comparison to control chicken.
Primary Outcome Measure Information:
Title
Change in vitamin D concentration
Description
Vitamin D3, vitamin D2, 25(OH)D3, 25(OH)D2) (nmol/L) in serum/plasma
Time Frame
Change over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)
Secondary Outcome Measure Information:
Title
Calcium serum concentrations
Description
Adjusted calcium
Time Frame
Monitored over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)
Title
Parathyroid hormone (PTH) concentration
Description
Plasma levels
Time Frame
Change over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: · Free-living, apparently healthy Caucasian adults Aged 18-65 years at Recruitment Body Mass Index (BMI) ≥18.5 and <25kg/m2 If consuming vitamin D supplements, willing to discontinue 4 weeks prior and for duration of study Non-smokers Exclusion Criteria: · Non-Caucasian adults Adults <18 or >65 years at recruitment Taking vitamin D supplement and not willing to discontinue vitamin D supplementation for 4 weeks prior to and for duration of study Current smokers Pregnant/lactating females Use of tanning facilities or winter vacation planned during the intervention period to a location expected to increase cutaneous synthesis Severe medical illness Medications which interfere with vitamin D metabolism e.g. steroid medications (e.g. prednisone), weight loss drug orlistat (e.g. Xenical and Alli), cholesterol-lowering drug cholestyramine (e.g. Questran, LoCholest and Prevalite), seizure drugs Phenobarbital and Dilantin, anti-tuberculosis, statins or thiazide diuretics Intestinal malabsorption syndrome Excessive alcohol use (>14 units/ week)
Facility Information:
Facility Name
Human Intervention Studies Unit, Ulster University
City
Coleraine
State/Province
Co.Londonderry
ZIP/Postal Code
BT52 1SA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Vitamin D Enriched Meat Project (Acute Study)

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