Beta-cryptoxanthin Supplement: Absorption and Function

Not Applicable

Completed

• Conditions: Beta-cryptoxanthin Supplementation
• Interventions: Dietary Supplement: Beta-cryptoxanthin (BCX)

• Registration Number: NCT05046457
• Lead Sponsor: Institute for Human Development and Potential (IHDP), Singapore

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.

Study Timeline

• Study First Submitted: 2021-08-23
• Study Start: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-16
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6mg BCX supplement	Beta-cryptoxanthin (BCX)	Two 3mg BCX capsules to be taken once per day for 8 weeks
3mg BCX supplement	Beta-cryptoxanthin (BCX)	One 3mg BCX capsule + one placebo capsule to be taken once per day for 8 weeks
0mg BCX supplementation	Beta-cryptoxanthin (BCX)	Two placebo capsules to be taken once per day for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in plasma concentration of BCX over 8 weeks	Baseline, Week 2, Week 4, Week 8	Fasting plasma carotenoids concentrations

Secondary Outcome Measures

Name	Time	Method
Change in Body Mass Index (BMI)	Baseline, Week 8	BMI in kg/m\^2 (from converted height in centimeters to meters)
Change in waist circumference	Baseline, Week 8	Waist circumference in centimeters (cm)
Change in State-Trait Anxiety Inventory (STAI) scores	Baseline, Week 8	- STAI scores for measures of anxiety
Change in gut microbiota composition	Baseline, Week 8	- Assessed by 16S rRNA gene sequencing of stool sample
Change in sleep/wake time	Baseline, Week 8	- Assessed with 7 consecutive days of total sleep time and wake after sleep onset measured using a wrist worn accelerometer
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (QLES) scores	Baseline, Week 8	- QLES scores for measures of the degree of life satisfaction
Change in body composition - Total body fat	Baseline, Week 8	Body fat analysis in percentage (%)
Changes in General Health Questionnaire (GHQ-12) scores	Baseline, Week 8	- GHQ-12 scores for measure of physiological distress
Change in Satisfaction with Life Scale (SLS) scores	Baseline, Week 8	- SLS scores for measures of subjective well-being
Height measurement	Baseline	Height in centimeters (cm)
Change in Pittsburgh Sleep Quality Index (PSQI) scores	Baseline, Week 8	- PSQI scores for measures of sleep quality and patterns
Change in weight	Baseline, Week 8	Weight in kilograms (kg)
Change in Perceived Stress Scale (PSS) scores	Baseline, Week 8	- PSS scores for measures of stress perceptions
Change in Depression Anxiety Stress Scales (DASS) scores	Baseline, Week 2, Week 4, Week 8	- DASS scores for measures of the negative emotional states of depression, anxiety and stress
Change in physical activity	Baseline, Week 8	- Assessed with 7 consecutive days of raw acceleration, steps taken and activity counts measured using a wrist worn accelerometer

Trial Locations

Locations (1)

Singapore Institute for Clinical Sciences; 🇸🇬 Singapore, Singapore