Impact of Antioxidant-rich Supplementation on Skin Carotenoids Status, Antioxidant Status and Cardiometabolic Health in Overweight and Obese Individuals

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorNational University of Singapore

About this trial

This study aims to evaluate the effects of antioxidant-rich supplementation on skin carotenoid status, antioxidant status, and cardiometabolic health in overweight and obese individuals. The study may provide additional scientific evidence to support the further refinement of current dietary and nutritional recommendations.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able to give informed consent (AMT score ≥ 8 for older adults [65-70 years old])

Adults 21-70 years old

English-literate

Have venous access sufficient to allow for blood sampling as per the protocol

Disqualifiers

Weight change > 3kg in the past 3 months

Exercising vigorously over the past 3 months

Taking medications or dietary supplements which may impact eye/skin health

Taking lipid-lowering and blood pressure controlling medications less than 3 years

Trial design

Design model

Parallel

Treatments tested in this trial

  • Antioxidant-rich supplementation Element

    Dietary supplement

    Maintained habitual diet with additionally taking LifePak Element for 12 weeks

  • Antioxidant-rich supplementation Optimal

    Dietary supplement

    Maintaining habitual diet with additionally taking LifePak Optimal for 12 weeks

Treatment groups

83 Participants
are divided into 3 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: LifePak Elements SupplementationExperimental treatment 1 intervention
Group C: LifePak Optimal SupplementationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Skin Carotenoid Score Measured by Prysm iO™ from Baseline to Week 12

Skin carotenoid status will be assessed using the Prysm iO™ device. The device scans the participant's fingertip and provides a skin carotenoid score, also referred to as the Prysm Score. Results will be reported as the numerical Prysm Score. Higher scores indicate higher skin carotenoid levels.

Time frame
Week 0, 4, 8, 12
2

Mean Change from Baseline in Blood Carotenoid Concentration

Blood carotenoid concentration will be assessed using blood samples collected from participants. Results will be reported as the mean change from baseline in blood carotenoid concentration at Week 12. Higher concentrations indicate higher circulating carotenoid status.

Time frame
Week 0 and Week 12

Secondary outcomes

1

Mean Change from Baseline in Total Antioxidant Capacity in Blood Samples

Total antioxidant capacity will be assessed using blood samples collected from participants. Results will be reported as the mean change from baseline in total antioxidant capacity at each post-baseline time point.

Time frame
Week 0 and Week 12
2

Mean Change from Baseline in Fasting Blood Lipid and Lipoprotein Concentrations

Fasting blood lipid and lipoprotein concentrations will be assessed using blood samples collected from participants after an overnight fast. The lipid and lipoprotein profile may include total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides. Results will be reported as the mean change from baseline in each lipid and lipoprotein parameter at Week 12.

Time frame
Week 0 and Week 12
3

Mean Change from Baseline in Fasting Blood Glucose Concentration

Fasting blood glucose concentration will be assessed using blood samples collected from participants after an overnight fast. Results will be reported as the mean change from baseline in fasting blood glucose concentration at Week 12.

Time frame
Week 0 and Week 12
4

Mean Change from Baseline in Fasting Blood Insulin Concentration

Fasting blood insulin concentration will be assessed using blood samples collected from participants after an overnight fast. Results will be reported as the mean change from baseline in fasting blood insulin concentration at Week 12.

Time frame
Week 0 and Week 12

Other outcomes

1

Mean Change from Baseline in Blood Clock Gene-Related Markers

Clock gene-related markers will be assessed using blood samples collected from participants. Results will be reported as the mean change from baseline in selected clock gene-related markers at Week 12. This outcome is exploratory and will be used to explore potential biological changes associated with the intervention.

Time frame
Week 0 and Week 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Singapore

Lead sponsor

Nu Skin Enterprises

Collaborator

This trial is not recruiting at the moment. You can still explore other options: