Clinical trial NCT05046457: Beta-cryptoxanthin Supplement: Absorption and Function
Official title: Beta-Cryptoxanthin (BCX) Supplementation and Circulating Carotenoid Concentrations in Women: A Randomized, Controlled, Double-blinded and 8 Week Parallel Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beta-cryptoxanthin Supplementation
Keywords: Beta-cryptoxanthin
Supplementation
Carotenoids
Bioavailability
Lead sponsor: Institute for Human Development and Potential (IHDP), Singapore
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2021-09-16
Enrollment: 90
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in plasma concentration of BCX over 8 weeks
timeFrame: Baseline, Week 2, Week 4, Week 8
Secondary outcomes:
measure: Height measurement
timeFrame: Baseline
measure: Change in weight
timeFrame: Baseline, Week 8
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, Week 8
measure: Change in waist circumference
timeFrame: Baseline, Week 8
measure: Change in body composition - Total body fat
timeFrame: Baseline, Week 8
measure: Changes in General Health Questionnaire (GHQ-12) scores
timeFrame: Baseline, Week 8
measure: Change in Pittsburgh Sleep Quality Index (PSQI) scores
timeFrame: Baseline, Week 8
measure: Change in State-Trait Anxiety Inventory (STAI) scores
timeFrame: Baseline, Week 8
measure: Change in Perceived Stress Scale (PSS) scores
timeFrame: Baseline, Week 8
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire (QLES) scores
timeFrame: Baseline, Week 8
measure: Change in Satisfaction with Life Scale (SLS) scores
timeFrame: Baseline, Week 8
measure: Change in Depression Anxiety Stress Scales (DASS) scores
timeFrame: Baseline, Week 2, Week 4, Week 8
measure: Change in gut microbiota composition
timeFrame: Baseline, Week 8
measure: Change in sleep/wake time
timeFrame: Baseline, Week 8
measure: Change in physical activity
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Institute for Clinical Sciences
Study officials:
affiliation: Institute for Human Development and Potential (IHDP), Singapore
name: Karen Tan Mei Ling, PhD
role: PRINCIPAL_INVESTIGATOR
References: