Cardio-vascular Protective Effects of Wolfberry in Middle-aged and Older Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 41
- Locations
- 4
- Primary Endpoint
- Change in Lipidomic Profiles
Study Overview
Brief Summary
This purpose of this study is to assess the impact of consuming wolfberry on cardiovascular risk in Singapore's middle-aged and older adults. The investigators hypothesize that consuming wolfberry with a healthy eating pattern diet will contribute to improvements in cardiovascular health when compared to a similar diet without wolfberry.
Detailed Description
This is a 16-week parallel, single-blind (investigator), prospective randomized controlled trial. The study was designed based on previous research which showed that consuming 15 g/day of wolfberry for 4 weeks and 14 g/day of wolfberry with meal for 6 weeks increased plasma zeaxanthin concentrations and antioxidant status. Also, other studies reported observable changes in the endothelial progenitor cells and flow mediated dilation after just two weeks of fruit and vegetables or healthy diet interventions. Thus collectively, 16-weeks may be a sufficient period to detect the changes in endothelial function, whole body carotenoids, and anti-oxidant status, which are the outcomes of interest in this research project.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Ability to give an informed consent
- •Age 50 to 75 years
- •Willing to follow the study procedures
Exclusion Criteria
- •Significant change in weight (± 5% body weight) during the past 3 months
- •Allergy to wolfberry
- •Acute illness at the study baseline
- •Exercising vigorously over the past 3 months
- •Consistently following healthy eating pattern diet in the past 3 months
- •Have an average weekly alcohol intake that above 21 units per week (males) and 14 units per week (females): 1 unit = 360 mL of beer; 150 mL of wine; 45 mL of distilled spirits)
- •Pregnant, lactating, or planning pregnancy in the next 6 months
- •Taking dietary supplements which may impact the outcome of interests (e.g. vitamin supplements, antioxidant supplement etc.)
- •Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 5 years prior to the intervention participation
- •Insufficient venous access to allow the blood collection
Outcomes
Primary Outcomes
Change in Lipidomic Profiles
Time Frame: Pre- and post-intervention (Week 16)
The main classes of lipids in the cell membrane
Change in Carotid Intima Media Thickness
Time Frame: Pre- and post-intervention (Week 16)
Carotid intima media thickness measured using high-frequency ultrasonographic imaging
Change in Endothelial Progenitor Cells
Time Frame: Pre- and post-intervention (Week 16)
Quantity and quality of circulating endothelial progenitor cells
Change in Flow Mediated Dilation
Time Frame: Pre- and post-intervention (Week 16)
Brachial artery flow mediated dilation measured using high-frequency ultrasonographic imaging
Change in Plasma Nitric Oxide
Time Frame: Pre- and post-intervention (Week 16)
Concentrations of plasma total nitrate/nitrite using commercially available ELISA assay kits.
Change in Blood Carotenoid Status
Time Frame: Pre- and post-intervention (Week 16)
Fasting state plasma carotenoids using high performance liquid chromatography.
Change in Plasma Endothelin-1
Time Frame: Pre- and post-intervention (Week 16)
Concentrations of plasma endothelin-1 using commercially available ELISA assay kits.
Change in Plasma ICAM-1
Time Frame: Pre- and post-intervention (Week 16)
Concentrations of plasma intercellular adhesion molecule-1 using commercially available ELISA assay kits.
Secondary Outcomes
- Change in Blood Lipid-lipoprotein Concentrations(Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported)
- Change in Blood Pressure(Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported)
- Change in Oxidative Stress-related Biomarkers(Pre- and post-intervention (Week 16))
- Change in Body Composition(Pre- and post-intervention (Week 16))
- Change in Skin Carotenoid Status(Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported)
- Body Mass Index(Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported)
- Change in Waist Circumference(Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported)
- Change in Appetite(Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported)
- Dietary Carotenoids(Pre- and post-intervention (Week 16))
- Change in Sleep Quality(Pre- and post-intervention (Week 16))
- Change in Cognitive Function(Pre- and post-intervention (Week 16))
Investigators
Jung Eun Kim
Assistant Professor
National University of Singapore