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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Diseases, Aging

Intervention / Treatment
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* Other: Wolfberry
* Other: Healthy diet


Participation Criteria
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Eligibility Criteria
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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 Smoking 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wolfberry with healthy diet<br>Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal. | Other: Wolfberry<br>* Consumption of cooked dehydrated wolfberry as part of a mixed meal.<br>Other: Healthy diet<br>* Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.<br>|
| Active Comparator: Healthy diet<br>Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. | Other: Healthy diet<br>* Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lipidomic Profiles | The main classes of lipids in the cell membrane | Pre- and post-intervention (Week 16) | 
| Change in Carotid Intima Media Thickness | Carotid intima media thickness measured using high-frequency ultrasonographic imaging | Pre- and post-intervention (Week 16) | 
| Change in Endothelial Progenitor Cells | Quantity and quality of circulating endothelial progenitor cells | Pre- and post-intervention (Week 16) | 
| Change in Flow Mediated Dilation | Brachial artery flow mediated dilation measured using high-frequency ultrasonographic imaging | Pre- and post-intervention (Week 16) | 
| Change in Plasma Nitric Oxide | Concentrations of plasma total nitrate/nitrite using commercially available ELISA assay kits. | Pre- and post-intervention (Week 16) | 
| Change in Blood Carotenoid Status | Fasting state plasma carotenoids using high performance liquid chromatography. | Pre- and post-intervention (Week 16) | 
| Change in Plasma Endothelin-1 | Concentrations of plasma endothelin-1 using commercially available ELISA assay kits. | Pre- and post-intervention (Week 16) | 
| Change in Plasma ICAM-1 | Concentrations of plasma intercellular adhesion molecule-1 using commercially available ELISA assay kits. | Pre- and post-intervention (Week 16) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Lipid-lipoprotein Concentrations | Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and total triglyceride | 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 | 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. | Pre- and post-intervention (Week 16) | 
| Change in Body Composition | Dual-energy X-ray absorptiometry | 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 | 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) | 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 | 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) | 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 | Pre- and post-intervention (Week 16) | 
| Change in Sleep Quality | Measured using The Pittsburgh Sleep Quality Index (PSQI) and sleep evaluation questionnaire | Pre- and post-intervention (Week 16) | 
| Change in Cognitive Function | Measured using Montreal cognitive assessment (MOCA) | Pre- and post-intervention (Week 16) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wolfberry (Goji berry), Healthy diet, Cardiovascular diseases, Endothelial function, Lipidomics, Middle-aged and older adults, Oxidative stress, Inflammation