Wolfberry
OtherConsumption of cooked dehydrated wolfberry as part of a mixed meal.
NCT Number: NCT03535844
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.
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Notify Me50 year–75 year
All sexes
Interventional
Not applicable
National University Hospital, Singapore
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
Time frame: Pre- and post-intervention (Week 16)
The main classes of lipids in the cell membrane
Time frame: Pre- and post-intervention (Week 16)
Carotid intima media thickness measured using high-frequency ultrasonographic imaging
Time frame: Pre- and post-intervention (Week 16)
Quantity and quality of circulating endothelial progenitor cells
Time frame: Pre- and post-intervention (Week 16)
Brachial artery flow mediated dilation measured using high-frequency ultrasonographic imaging
Time frame: Pre- and post-intervention (Week 16)
Concentrations of plasma total nitrate/nitrite using commercially available ELISA assay kits.
Time frame: Pre- and post-intervention (Week 16)
Fasting state plasma carotenoids using high performance liquid chromatography.
Time frame: Pre- and post-intervention (Week 16)
Concentrations of plasma endothelin-1 using commercially available ELISA assay kits.
Time frame: Pre- and post-intervention (Week 16)
Concentrations of plasma intercellular adhesion molecule-1 using commercially available ELISA assay kits.
Time frame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and total triglyceride
Time frame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
Both systolic and diastolic blood pressure
Time frame: Pre- and post-intervention (Week 16)
Concentrations of plasma biomarkers of oxidative stress.
Time frame: Pre- and post-intervention (Week 16)
Dual-energy X-ray absorptiometry
Time frame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
Measured using resonance Raman spectroscopy to obtain a skin carotenoid status, a score which ranges from 10000 to 89000. Higher score represents higher concentration of carotenoids in skin, hence, an improved outcome
Time frame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
(body mass) divided by (height x height)
Time frame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
Measurement of waist circumference using World Health Organization guidelines
Time frame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
A subjective visual analogue scale consisting of a 100 mm line for each term (1) hunger; (2) fullness; (3) desire to eat; (4) prospective food consumption. Subjects respond by placing a mark on the line that is anchored with an extreme answer at either end (e.g. "not felt at all" and "felt the greatest")
A composite appetite score is computed by: (hunger + desire to eat + (100 - fullness) + prospective food consumption) divided by 4. With a maximum score of 400 for the greatest possible appetite (represented by hunger = 100; desire to eat = 100; fullness = 0 and prospective food consumption = 100) and a minimum score of 0 (represented by hunger = 0; desire to eat = 0; fullness = 100 and prospective food consumption = 0)
Time frame: Pre- and post-intervention (Week 16)
Analysis of dietary carotenoids using 3-day food records
Time frame: Pre- and post-intervention (Week 16)
Measured using The Pittsburgh Sleep Quality Index (PSQI) and sleep evaluation questionnaire
Time frame: Pre- and post-intervention (Week 16)
Measured using Montreal cognitive assessment (MOCA)
National University of Singapore
Other
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