NCT05046457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

September 7, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

August 23, 2021

Last Update Submit

April 5, 2022

Conditions

Beta-cryptoxanthin Supplementation

Keywords

Beta-cryptoxanthinSupplementationCarotenoidsBioavailability

Outcome Measures

Primary Outcomes (1)

  • Change in plasma concentration of BCX over 8 weeks

    Fasting plasma carotenoids concentrations

    Baseline, Week 2, Week 4, Week 8

Secondary Outcomes (15)

  • Height measurement

    Baseline

  • Change in weight

    Baseline, Week 8

  • Change in Body Mass Index (BMI)

    Baseline, Week 8

  • Change in waist circumference

    Baseline, Week 8

  • Change in body composition - Total body fat

    Baseline, Week 8

  • +10 more secondary outcomes

Study Arms (3)

3mg BCX supplement

EXPERIMENTAL

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

Dietary Supplement: Beta-cryptoxanthin (BCX)

6mg BCX supplement

EXPERIMENTAL

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

Dietary Supplement: Beta-cryptoxanthin (BCX)

0mg BCX supplementation

PLACEBO COMPARATOR

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

Dietary Supplement: Beta-cryptoxanthin (BCX)

Interventions

Beta-cryptoxanthin (BCX)DIETARY_SUPPLEMENT

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

0mg BCX supplementation3mg BCX supplement6mg BCX supplement

Eligibility Criteria

Age21 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 21 - 35 years old, residing in Singapore
  • Body mass index (BMI) between 18.5 to 27.5 kg/m2
  • Subject should not be pregnant or breastfeeding during study period
  • Subject should not be planning to conceive within 3 months from enrolment
  • Subject must voluntarily consent to participate in this study and provide their written informed consent prior to start of study
  • Subject is always willing to comply with study regulations and instructions

You may not qualify if:

  • Any current diagnosis or history of cardiovascular, hepatic, renal, metabolic (e.g. diabetes), immunological, gastrointestinal diseases, psychiatric disorders or chronic diseases
  • Participation in another simultaneous clinical study
  • Ongoing adherence to weight reduction diet and/or programs
  • Use of medication and supplementation with other carotenoids reasonable expected to impact on primary outcome (e.g. drug treatment for hyperlipidemia)
  • A history of drug abuse
  • Current smoker or excessive alcohol intake (\>4 standard drinks per day)
  • Subject has a known allergy or sensitivity to BCX or any ingredients of the study products provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Institute for Clinical Sciences

Singapore, Singapore

Location

MeSH Terms

Interventions

Beta-Cryptoxanthin

Intervention Hierarchy (Ancestors)

CryptoxanthinsXanthophyllsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Karen Tan Mei Ling, PhD

    Institute for Human Development and Potential (IHDP), Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Clinician

Study Record Dates

First Submitted

August 23, 2021

First Posted

September 16, 2021

Study Start

September 7, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

April 13, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)