Vitamin D Enriched Meat Project (Acute Study)

Sponsor

University of Ulster (Other)

Overall Status

Completed

CT.gov ID

NCT04207294

Collaborator

Devenish Nutrition, Lagan House, 19 Clarendon Road, Belfast, BT1 3BG (Other), Agri-Food and Biosciences Institute (AFBI), 18a Newforge Lane, Belfast, BT9 5P (Other)

Enrollment

Location

Arms

2.8

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency	Other: Pork arm Other: Chicken arm	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Bioavailability of Vitamin D-enriched Pork and Chicken in Comparison to a Vitamin D Supplement in Healthy Adults: an Acute Study

Actual Study Start Date :

Jan 16, 2020

Actual Primary Completion Date :

Apr 10, 2020

Actual Study Completion Date :

Apr 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin D-enriched pork One portion of Vitamin D-enriched pork	Other: Pork arm 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.
Placebo Comparator: Control pork One portion of control pork	Other: Pork arm 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.
Active Comparator: Vitamin D supplement Equivocal dose of Vitamin D supplement	Other: Pork arm 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.
Experimental: Vitamin D-enriched chicken One portion of Vitamin D-enriched chicken	Other: Chicken arm The effect of 1 portion of vitamin D-enriched chicken on 25(OH)D concentration in comparison to control chicken.
Placebo Comparator: Control chicken One portion of control chicken	Other: Chicken arm The effect of 1 portion of vitamin D-enriched chicken on 25(OH)D concentration in comparison to control chicken.

Outcome Measures

Primary Outcome Measures

Change in vitamin D concentration [Change over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)]
Vitamin D3, vitamin D2, 25(OH)D3, 25(OH)D2) (nmol/L) in serum/plasma

Secondary Outcome Measures

Calcium serum concentrations [Monitored over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)]
Adjusted calcium
Parathyroid hormone (PTH) concentration [Change over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)]
Plasma levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)