Antioxidant Status, Overweight , Obesity
Conditions
Keywords
Overweight, Obese, Antioxidants, Long-term, Body composition, Cardiometabolic health, Skin carotenoid
Brief summary
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.
Detailed description
This study will be a single-blind, randomized, parallel-group trial, and all participants will complete a 12-week study period. A total of 66 participants will be recruited and randomly assigned to continue their habitual diet with or without antioxidant-rich supplementation. This study aims to investigate whether antioxidant-rich supplementation will influence body composition, skin carotenoid status, antioxidant status, and cardiometabolic health. The study will comprise 1 screening visit and 4 test visits.
Interventions
DIETARY_SUPPLEMENTAntioxidant-rich supplementation Element
Maintained habitual diet with additionally taking LifePak Element for 12 weeks
DIETARY_SUPPLEMENTAntioxidant-rich supplementation Optimal
Maintaining habitual diet with additionally taking LifePak Optimal for 12 weeks
Sponsors
National University of Singapore
Nu Skin Enterprises
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * No drastic change of diet for the past 1 year * If taking medication, has been consistently taking antihypertensive/cholesterol-lowering/type-2 diabetic medication for more than 3 years prior to starting the study
Exclusion criteria
* 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 * Smoking * Drinking more than 2 alcoholic drinks per day * Pregnant, lactating, or planning pregnancy in the next 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Carotenoid Score Measured by Prysm iO™ from Baseline to Week 12 | Week 0, 4, 8, 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. |
| Mean Change from Baseline in Blood Carotenoid Concentration | Week 0 and Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change from Baseline in Total Antioxidant Capacity in Blood Samples | Week 0 and Week 12 | 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. |
| Mean Change from Baseline in Fasting Blood Lipid and Lipoprotein Concentrations | Week 0 and Week 12 | 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. |
| Mean Change from Baseline in Fasting Blood Glucose Concentration | Week 0 and Week 12 | 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. |
| Mean Change from Baseline in Fasting Blood Insulin Concentration | Week 0 and Week 12 | 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. |
| Mean Change from Baseline in Blood Biomarkers of Oxidative Stress: Malondialdehyde and 8-Isoprostane | Week 0 and Week 12 | Oxidative stress will be assessed using blood samples collected from participants. Blood biomarkers of oxidative stress will include malondialdehyde and 8-isoprostane. Results will be reported as the mean change from baseline in malondialdehyde concentration and 8-isoprostane concentration at Week 12. Higher concentrations indicate higher levels of oxidative stress. |
| Mean Change from Baseline in Skin Autofluorescence Measured by AGE Reader mu Connect | Week 0, 4, 8, 12 | Skin advanced glycation end product accumulation will be assessed non-invasively using the AGE Reader mu Connect. The device measures skin tissue autofluorescence on the inside of the participant's dominant lower forearm. Results will be reported as the mean change from baseline in AGE Reader measurement result, expressed in arbitrary units. Higher values indicate higher skin advanced glycation end product accumulation. |
| Mean Change from Baseline in Blood Advanced Glycation End Product Level | Week 0 and Week 12 | Blood advanced glycation end product level will be assessed using blood samples collected from participants. Results will be reported as the mean change from baseline in blood advanced glycation end product level at Week 12. |
| Mean change from baseline in anthropometric and body composition parameters | Week 0, 4, 8, 12 | Anthropometric and body composition parameters will be assessed using standard measurements and InBody body composition analysis. Parameters may include body weight, waist circumference, body fat percentage, fat mass, fat-free mass, skeletal muscle mass and body mass index. Results will be reported as the mean change from baseline at each post-baseline time point. |
Countries
Singapore
Contacts
CONTACTLingyin Yu, B.Sc.
PRINCIPAL_INVESTIGATORJung Eun Kim, Ph.D., R.D.
National University of Singapore, Department of Food Science and Technology
Outcome results
None listed