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
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
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
NCT ID
NCT04207294
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
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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