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Completed

NCT Number: NCT04207294

Vitamin D Enriched Meat Project (Acute Study)

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, BT52 1SA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pork arm

Other

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.

Chicken arm

Other

The effect of 1 portion of vitamin D-enriched chicken on 25(OH)D concentration in comparison to control chicken.

Primary outcomes

  1. Change in vitamin D concentration

    Time frame: 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 outcomes

  1. Calcium serum concentrations

    Time frame: Monitored over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)

    Adjusted calcium

  2. Parathyroid hormone (PTH) concentration

    Time frame: Change over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)

    Plasma levels

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Agri-Food and Biosciences Institute
  • Devenish Nutrition, Lagan House, 19 Clarendon Road, Belfast, BT1 3BG

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 20, 2019
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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