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Not yet recruiting NCT07748468

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

No phase Interventional Overweight , Obesity Antioxidant Status

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Antioxidant-rich supplementation Element, Antioxidant-rich supplementation Optimal.
Who it may be relevant to
Registry conditions: Overweight , Obesity, Antioxidant Status. Basic parameters: 21 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 supplement Antioxidant-rich supplementation Element
    Maintained habitual diet with additionally taking LifePak Element for 12 weeks
  • Dietary supplement Antioxidant-rich supplementation Optimal
    Maintaining habitual diet with additionally taking LifePak Optimal for 12 weeks

Primary outcome measures

  • Change in Skin Carotenoid Score Measured by Prysm iO™ from Baseline to Week 12 [Time frame: Week 0, 4, 8, 12]
  • Mean Change from Baseline in Blood Carotenoid Concentration [Time frame: Week 0 and Week 12]
Secondary outcome measures (8)
  • Mean Change from Baseline in Total Antioxidant Capacity in Blood Samples [Time frame: Week 0 and Week 12]
  • Mean Change from Baseline in Fasting Blood Lipid and Lipoprotein Concentrations [Time frame: Week 0 and Week 12]
  • Mean Change from Baseline in Fasting Blood Glucose Concentration [Time frame: Week 0 and Week 12]
  • Mean Change from Baseline in Fasting Blood Insulin Concentration [Time frame: Week 0 and Week 12]
  • Mean Change from Baseline in Blood Biomarkers of Oxidative Stress: Malondialdehyde and 8-Isoprostane [Time frame: Week 0 and Week 12]
  • Mean Change from Baseline in Skin Autofluorescence Measured by AGE Reader mu Connect [Time frame: Week 0, 4, 8, 12]
  • Mean Change from Baseline in Blood Advanced Glycation End Product Level [Time frame: Week 0 and Week 12]
  • Mean change from baseline in anthropometric and body composition parameters [Time frame: Week 0, 4, 8, 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Singapore · 1 center
  • NUS, Department of Food Science and Technology, 1 Science Drive 3, Block S13, #03-07, Sing — Singapore

Identifiers

NCT: NCT07748468 · S39 · NUS-IRB-2026-268

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗