Vitamin D Enriched Meat Project (Acute Study)

NCT04207294 | Completed

• 1 other identifier: REC/19/0040
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

Vitamin D; Pork; Chicken; Bioavailability; 25 hydroxyvitamin D; Adults; RCT; Crossover

Outcome Measures

Primary Outcomes (1)

• Change in vitamin D concentration

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

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

Secondary Outcomes (2)

• Calcium serum concentrations

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

• Parathyroid hormone (PTH) concentration

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

Study Arms (5)

Vitamin D-enriched pork

EXPERIMENTAL

One portion of Vitamin D-enriched pork

Other: Pork arm

Control pork

PLACEBO COMPARATOR

One portion of control pork

Other: Pork arm

Vitamin D supplement

ACTIVE COMPARATOR

Equivocal dose of Vitamin D supplement

Other: Pork arm

Vitamin D-enriched chicken

EXPERIMENTAL

One portion of Vitamin D-enriched chicken

Other: Chicken arm

Control chicken

PLACEBO COMPARATOR

One portion of control chicken

Other: Chicken arm

Interventions

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.

Control pork; Vitamin D supplement; Vitamin D-enriched pork

Chicken arm OTHER

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

Control chicken; Vitamin D-enriched chicken

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• · 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

You may not qualify if:

• · 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)

Sponsors & Collaborators

• University of Ulster: lead
• Devenish Nutrition, Lagan House, 19 Clarendon Road, Belfast, BT1 3BG: collaborator
• Agri-Food and Biosciences Institute: collaborator

Study Sites (1)

Human Intervention Studies Unit, Ulster University

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

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: January 16, 2020
• Primary Completion: April 10, 2020
• Study Completion: April 10, 2020
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)