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Effect of SNPs in the BCMO1 Enzyme (BETASNP2)

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ClinicalTrials.gov Identifier: NCT02276014
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : October 6, 2015
Sponsor:
Collaborators:
Newcastle University
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Tracking Information
First Submitted Date  ICMJE October 21, 2014
First Posted Date  ICMJE October 27, 2014
Last Update Posted Date October 6, 2015
Study Start Date  ICMJE April 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
  • Area under the plasma concentration versus time curve (AUC) of beta-carotene [ Time Frame: Pharmacokinetic measures (0,1,4,36,46,57,60 days post-dose) ]
  • Area under the plasma concentration versus time curve (AUC) of [13C]retinol [ Time Frame: Pharmacokinetic measures (0,1,2,3,4,8,10,22,36,46,57,58,59,60,64,66,78,92,113 days post-dose) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of SNPs in the BCMO1 Enzyme
Official Title  ICMJE Effect of SNPs in the Beta-carotene 15, 15'-Monooxygenase (BCMO1) Enzyme on Retinol Formation and Beta-carotene Plasma Responses
Brief Summary

Summary:

Chronic intake of foods low in vitamin A (retinol) and provitamin A forming an unbalanced diet with little variety is common in young individuals in the United Kingdom (UK) population and can lead to subclinical micronutrient deficiency. Provitamin A sources such as β-carotene are cleaved centrally by the β-carotene 15,15'-monooxygenase (BCMO1) into retinal, the precursor of retinol. However, the amount of β-carotene and retinol produced after ingestion of β-carotene is highly variable between healthy individuals, with approximately 40% of the subjects being classified as low responders. Several stable isotope studies have shown a large disparity between the most efficient converters and the most inefficient converters of β-carotene with variations of up to 8-fold. It is possible that differences in β-carotene response may be due to single nucleotide polymorphisms (SNPs) in genes involved in aspects of β-carotene conversion. Previous work has shown that carriers of both, the 379V and 267S+379V BCMO1 variant alleles had a reduced ability to convert β-carotene. More importantly, 44% of the western population have the 379V haplotype. A high percentage of the Western population may therefore not be able to achieve adequate vitamin A intake if dietary β-carotene is a major source of their vitamin A intake. This is of particular relevance to vegetarians, to young individuals aged 19-24 years who have lower intakes of preformed retinol than any other age group, and to pregnant women. The aim of this study is to establish whether the maximum recommended dose for β-carotene of 7mg/day by the British Expert Committee on Vitamins and Minerals (EVM) can overcome the SNP effect in the BCMO1 enzyme.

Hypothesis:

The investigators hypothesize that the current maximum recommended intake of 7 mg of β-carotene per day cannot overcome the low convertor phenotype in BCMO1 to fulfill vitamin A requirements in these people.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE
  • Beta-carotene Bioavailability
  • Vitamin A Deficiency
Intervention  ICMJE Dietary Supplement: Beta-carotene
Study Arms  ICMJE
  • Supplement A
    Beta-carotene 7mg formulation A
    Intervention: Dietary Supplement: Beta-carotene
  • Supplement B
    Beta-carotene 7mg formulation B
    Intervention: Dietary Supplement: Beta-carotene
  • Supplement C
    Beta-carotene 7mg formulation C
    Intervention: Dietary Supplement: Beta-carotene
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2014)
85
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy individual.
  • Female.
  • Between 18 and 45 years of age.
  • Caucasian.
  • BMI between 18 and 30 kg/m2.
  • Subject willing and able to give written informed consent.

Exclusion Criteria:

  • Smoking.
  • Diabetes.
  • Gastrointestinal diseases.
  • Renal and hepatic diseases.
  • Hyperlipidaemia.
  • Preformed dietary retinol intake above 60% of reference nutrient intake (RNI) values.
  • Recreational drug use.
  • Multi-vitamin consumption.
  • Pregnancy.
  • Menopause.
  • Allergy or sensitivity to study products or ingredients.
  • Blood donation 3 months prior to screening.
  • Participation in other clinical study 4 weeks prior to study start.
  • Suspected inability or unwillingness to comply with study procedures.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02276014
Other Study ID Numbers  ICMJE 2011-01-18-BETASNP2
REC 11/NE/0211 ( Other Identifier: National Research Ethics Service (NRES) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Newcastle-upon-Tyne Hospitals NHS Trust
Study Sponsor  ICMJE Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators  ICMJE
  • Newcastle University
  • DSM Nutritional Products, Inc.
Investigators  ICMJE
Principal Investigator: Georg Lietz, PhD Newcastle University
PRS Account Newcastle-upon-Tyne Hospitals NHS Trust
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP