Effect of SNPs in the BCMO1 Enzyme

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Carotenoid Supplementation and Normal Ocular Health

NCT02147171

Retinal Ageing

COMPLETED PHASE2/PHASE3

Investigation of the Genetic and Environmental Determinants of MP Including Response to Supplementation

NCT01778231

Healthy

COMPLETED NA

Carotenoid Supplementation and Retinal Health in Healthy Adults

NCT07314411

Healthy

RECRUITING NA

The Influence of Lutein Supplements on Age-related Macular Degeneration

NCT01042860

Age-Related Macular Degeneration

COMPLETED NA

Effects of Lutein in Retinitis Pigmentosa

NCT00029289

Retinitis Pigmentosa

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Beta-carotene Bioavailability Vitamin A Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Supplement A

Beta-carotene 7mg formulation A

Group Type OTHER

Beta-carotene

Intervention Type DIETARY_SUPPLEMENT

Supplement B

Beta-carotene 7mg formulation B

Group Type OTHER

Beta-carotene

Intervention Type DIETARY_SUPPLEMENT

Supplement C

Beta-carotene 7mg formulation C

Group Type OTHER

Beta-carotene

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Beta-carotene

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes