Beta-cryptoxanthin Supplement: Absorption and Function

NCT ID: NCT05046457

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-07
• Study Completion Date: 2022-03-31

Brief Summary

Beta-cryptoxanthin (BCX) is a naturally occurring member of the carotenoid family, found in a wide range of fruits and vegetables. The unique biological functions of BCX have not been well-established, although BCX, like other members of the carotenoids have antioxidant functions. BCX, may also serve as a precursor of Vitamin A. Vitamin A has a wide range of functions including maintain immunity, vision, growth and development. Whilst not specific for BCX, epidemiological studies indicate that dietary intake of carotenoids may be of benefit in maintaining cognitive health and reducing stress via its antioxidant, anti-inflammatory and immunomodulatory properties. This pilot study aims to establish the relationship between supplemental dose and circulating concentrations of BCX and related carotenoids in circulation. Results obtained from this study will provide greater insight of bioavailability and carotenoid metabolism, necessary for larger supplementation in selected target populations.

Detailed Description

In previous Singapore maternal and child health cohort study, Growing up towards healthy outcomes (GUSTO), it established potentially significant health function to be significantly correlated with BCX. At childbirth, mothers' blood concentrations of carotenoids, including α-, β-carotene and BCX were simultaneously measured by ultra-performance liquid chromatography. Unique to the carotenoids, there was a correlation between higher maternal plasma concentrations of BCX with lower rates of depression and reduced anxiety scores during pregnancy for the mother. Furthermore, the concentrations of BCX were uniquely correlated with child neurocognitive function by age 2 years.

Current studies have only been food-based efficacy trials with an increase of dietary BCX intake through BCX-rich foods in humans. There have been no direct assessments of risk associated with BCX exposure, and current evidence in the literature does not identify any consistent, substantial risks for any level of BCX supplementation. Overall, the utility of BCX as a pro-vitamin A is clear, but evidence towards benefits beyond this role is inconsistent.

Hence, this is a pilot study that will aim to examine bioavailability of a novel BCX preparation supplemented at 2 doses (3mg and 6mg daily) versus placebo, consumed once daily in a randomised, doubled-blinded parallel trial, in healthy female subjects of reproductive age.

Conditions

Beta-cryptoxanthin Supplementation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

3mg BCX supplement

One 3mg BCX capsule + one placebo capsule to be taken once per day for 8 weeks

Group Type: EXPERIMENTAL

Beta-cryptoxanthin (BCX)

Intervention Type: DIETARY_SUPPLEMENT

Subjects will be randomised into one of the three study treatment arms.

6mg BCX supplement

Two 3mg BCX capsules to be taken once per day for 8 weeks

Group Type: EXPERIMENTAL

Beta-cryptoxanthin (BCX)

Intervention Type: DIETARY_SUPPLEMENT

Subjects will be randomised into one of the three study treatment arms.

0mg BCX supplementation

Two placebo capsules to be taken once per day for 8 weeks

Group Type: PLACEBO_COMPARATOR

Beta-cryptoxanthin (BCX)

Intervention Type: DIETARY_SUPPLEMENT

Subjects will be randomised into one of the three study treatment arms.

Interventions

Beta-cryptoxanthin (BCX)

Subjects will be randomised into one of the three study treatment arms.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Women aged 21 - 35 years old, residing in Singapore

2. Body mass index (BMI) between 18.5 to 27.5 kg/m2

3. Subject should not be pregnant or breastfeeding during study period

4. Subject should not be planning to conceive within 3 months from enrolment

5. Subject must voluntarily consent to participate in this study and provide their written informed consent prior to start of study

6. Subject is always willing to comply with study regulations and instructions

Exclusion Criteria

1. Any current diagnosis or history of cardiovascular, hepatic, renal, metabolic (e.g. diabetes), immunological, gastrointestinal diseases, psychiatric disorders or chronic diseases

2. Participation in another simultaneous clinical study

3. Ongoing adherence to weight reduction diet and/or programs

4. Use of medication and supplementation with other carotenoids reasonable expected to impact on primary outcome (e.g. drug treatment for hyperlipidemia)

5. A history of drug abuse

6. Current smoker or excessive alcohol intake (>4 standard drinks per day)

7. Subject has a known allergy or sensitivity to BCX or any ingredients of the study products provided

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: collaborator

Institute for Human Development and Potential (IHDP), Singapore

OTHER

Sponsor Role: lead

Responsible Party

Karen Tan Mei Ling

Research Clinician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Tan Mei Ling, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Human Development and Potential (IHDP), Singapore

Locations

Singapore Institute for Clinical Sciences

Singapore, , Singapore

Countries

Singapore

Other Identifiers

2021/00455

Identifier Type: -

Identifier Source: org_study_id