Beta-cryptoxanthin SupplementationBETA+NCT05046457
Beta-cryptoxanthin Supplement: Absorption and Function
A study testing Beta-cryptoxanthin (BCX) in people with Beta-cryptoxanthin Supplementation, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Beta-cryptoxanthin Supplementation
- What is being tested?
- Beta-cryptoxanthin (BCX)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Sep 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beta-Cryptoxanthin (BCX) Supplementation and Circulating Carotenoid Concentrations in Women: A Randomized, Controlled, Double-blinded and 8 Week Parallel Trial
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.
Read the 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
- Being tested
- Beta-cryptoxanthin (BCX)
- Keywords
- Beta-cryptoxanthin, Supplementation, Carotenoids, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-cryptoxanthin (BCX)Dietary supplement
Subjects will be randomised into one of the three study treatment arms.
| Study group | Role | What they receive |
|---|---|---|
| 3mg BCX supplement | Experimental | One 3mg BCX capsule + one placebo capsule to be taken once per day for 8 weeks Receives: Dietary Supplement: Beta-cryptoxanthin (BCX) |
| 6mg BCX supplement | Experimental | Two 3mg BCX capsules to be taken once per day for 8 weeks Receives: Dietary Supplement: Beta-cryptoxanthin (BCX) |
| 0mg BCX supplementation | Placebo comparator | Two placebo capsules to be taken once per day for 8 weeks Receives: Dietary Supplement: Beta-cryptoxanthin (BCX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma concentration of BCX over 8 weeks
Fasting plasma carotenoids concentrations
Measured: Baseline, Week 2, Week 4, Week 8
Secondary outcomes (15)
Height measurement
Height in centimeters (cm)
Measured: Baseline
Change in weight
Weight in kilograms (kg)
Measured: Baseline, Week 8
Change in Body Mass Index (BMI)
BMI in kg/m^2 (from converted height in centimeters to meters)
Measured: Baseline, Week 8
Change in waist circumference
Waist circumference in centimeters (cm)
Measured: Baseline, Week 8
Change in body composition - Total body fat
Body fat analysis in percentage (%)
Measured: Baseline, Week 8
Changes in General Health Questionnaire (GHQ-12) scores
- GHQ-12 scores for measure of physiological distress
Measured: Baseline, Week 8
Change in Pittsburgh Sleep Quality Index (PSQI) scores
- PSQI scores for measures of sleep quality and patterns
Measured: Baseline, Week 8
Change in State-Trait Anxiety Inventory (STAI) scores
- STAI scores for measures of anxiety
Measured: Baseline, Week 8
Change in Perceived Stress Scale (PSS) scores
- PSS scores for measures of stress perceptions
Measured: Baseline, Week 8
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (QLES) scores
- QLES scores for measures of the degree of life satisfaction
Measured: Baseline, Week 8
Change in Satisfaction with Life Scale (SLS) scores
- SLS scores for measures of subjective well-being
Measured: Baseline, Week 8
Change in Depression Anxiety Stress Scales (DASS) scores
- DASS scores for measures of the negative emotional states of depression, anxiety and stress
Measured: Baseline, Week 2, Week 4, Week 8
Change in gut microbiota composition
- Assessed by 16S rRNA gene sequencing of stool sample
Measured: Baseline, Week 8
Change in sleep/wake time
- Assessed with 7 consecutive days of total sleep time and wake after sleep onset measured using a wrist worn accelerometer
Measured: Baseline, Week 8
Change in physical activity
- Assessed with 7 consecutive days of raw acceleration, steps taken and activity counts measured using a wrist worn accelerometer
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start7 Sep 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta-cryptoxanthin SupplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Human Development and Potential (IHDP), Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Karen Tan Mei Ling, Institute for Human Development and Potential (IHDP), Singapore
- Investigators
- Karen Tan Mei Ling, PhD, Principal investigator, Institute for Human Development and Potential (IHDP), Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046457
- Sponsor's protocol ID
- 2021/00455
- Acronym
- BETA+
- Status last verified
- Apr 2022
- First submitted
- 23 Aug 2021
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-Cryptoxanthin (BCX) Supplementation and Circulating Carotenoid Concentrations in Women: A Randomized, Controlled, Double-blinded and 8 Week Parallel Trial
- ClinicalTrials.gov ID
- NCT05046457
- Acronym / sponsor ID
- BETA+ / 2021/00455
- Conditions
- Beta-cryptoxanthin Supplementation
- Keywords
- Beta-cryptoxanthin, Supplementation, Carotenoids, Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Institute for Human Development and Potential (IHDP), SingaporeUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3mg BCX supplement | Experimental | Dietary Supplement: Beta-cryptoxanthin (BCX)One 3mg BCX capsule + one placebo capsule to be taken once per day for 8 weeks |
| 6mg BCX supplement | Experimental | Dietary Supplement: Beta-cryptoxanthin (BCX)Two 3mg BCX capsules to be taken once per day for 8 weeks |
| 0mg BCX supplementation | Placebo comparator | Dietary Supplement: Beta-cryptoxanthin (BCX)Two placebo capsules to be taken once per day for 8 weeks |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-cryptoxanthin (BCX)Subjects will be randomised into one of the three study treatment arms. | Dietary supplement | 0mg BCX supplementation, 3mg BCX supplement, 6mg BCX supplement |
Primary outcome
Change in plasma concentration of BCX over 8 weeks
Time frame: Baseline, Week 2, Week 4, Week 8
Fasting plasma carotenoids concentrations
15 secondary outcomes
Height measurement
Time frame: Baseline
Change in weight
Time frame: Baseline, Week 8
Change in Body Mass Index (BMI)
Time frame: Baseline, Week 8
Change in waist circumference
Time frame: Baseline, Week 8
Change in body composition - Total body fat
Time frame: Baseline, Week 8
Changes in General Health Questionnaire (GHQ-12) scores
Time frame: Baseline, Week 8
Change in Pittsburgh Sleep Quality Index (PSQI) scores
Time frame: Baseline, Week 8
Change in State-Trait Anxiety Inventory (STAI) scores
Time frame: Baseline, Week 8
Change in Perceived Stress Scale (PSS) scores
Time frame: Baseline, Week 8
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (QLES) scores
Time frame: Baseline, Week 8
Change in Satisfaction with Life Scale (SLS) scores
Time frame: Baseline, Week 8
Change in Depression Anxiety Stress Scales (DASS) scores
Time frame: Baseline, Week 2, Week 4, Week 8
Change in gut microbiota composition
Time frame: Baseline, Week 8
Change in sleep/wake time
Time frame: Baseline, Week 8
Change in physical activity
Time frame: Baseline, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Tan Mei Ling, PhD principal investigator
Institute for Human Development and Potential (IHDP), Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-cryptoxanthin (BCX) in people with Beta-cryptoxanthin Supplementation, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma concentration of BCX over 8 weeks (time frame: Baseline, Week 2, Week 4, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.