Cardio-vascular Protective Effects of Wolfberry in Middle-aged and Older Adults

National University of Singapore41 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Cardiovascular Diseases Aging

Interventions

WolfberryOTHER

Consumption of cooked dehydrated wolfberry as part of a mixed meal.

Healthy dietOTHER

Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Ability to give an informed consent 2. Age 50 to 75 years 3. Willing to follow the study procedures Exclusion Criteria: 1. Significant change in weight (± 5% body weight) during the past 3 months 2. Allergy to wolfberry 3. Acute illness at the study baseline 4. Exercising vigorously over the past 3 months 5. Consistently following healthy eating pattern diet in the past 3 months 6. Smoking 7. 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) 8. Pregnant, lactating, or planning pregnancy in the next 6 months 9. Taking dietary supplements which may impact the outcome of interests (e.g. vitamin supplements, antioxidant supplement etc.) 10. Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 5 years prior to the intervention participation 11. Insufficient venous access to allow the blood collection

Locations (2)

National University of Singapaore

Singapore, Singapore

National University Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

Change in Lipidomic Profiles

The main classes of lipids in the cell membrane

Time frame: Pre- and post-intervention (Week 16)

Change in Carotid Intima Media Thickness

Carotid intima media thickness measured using high-frequency ultrasonographic imaging

Time frame: Pre- and post-intervention (Week 16)

Change in Endothelial Progenitor Cells

Quantity and quality of circulating endothelial progenitor cells

Time frame: Pre- and post-intervention (Week 16)

Change in Flow Mediated Dilation

Brachial artery flow mediated dilation measured using high-frequency ultrasonographic imaging

Time frame: Pre- and post-intervention (Week 16)

Change in Plasma Nitric Oxide

Concentrations of plasma total nitrate/nitrite using commercially available ELISA assay kits.

Time frame: Pre- and post-intervention (Week 16)

Change in Blood Carotenoid Status

Fasting state plasma carotenoids using high performance liquid chromatography.

Time frame: Pre- and post-intervention (Week 16)

Change in Plasma Endothelin-1

Concentrations of plasma endothelin-1 using commercially available ELISA assay kits.

Time frame: Pre- and post-intervention (Week 16)

Change in Plasma ICAM-1

Concentrations of plasma intercellular adhesion molecule-1 using commercially available ELISA assay kits.

Data from ClinicalTrials.gov

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Secondary Outcomes

Change in Blood Lipid-lipoprotein Concentrations

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

Change in Blood Pressure

Both systolic and diastolic blood pressure

Time frame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported

Change in Oxidative Stress-related Biomarkers

Concentrations of plasma biomarkers of oxidative stress.

Time frame: Pre- and post-intervention (Week 16)

Change in Body Composition

Dual-energy X-ray absorptiometry

Time frame: Pre- and post-intervention (Week 16)

Change in Skin Carotenoid Status

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 Index

(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

Change in Waist Circumference

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

Change in Appetite

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: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported

Dietary Carotenoids

Analysis of dietary carotenoids using 3-day food records

Time frame: Pre- and post-intervention (Week 16)

Change in Sleep Quality

Measured using The Pittsburgh Sleep Quality Index (PSQI) and sleep evaluation questionnaire

Time frame: Pre- and post-intervention (Week 16)

Change in Cognitive Function

Measured using Montreal cognitive assessment (MOCA)

Time frame: Pre- and post-intervention (Week 16)