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

National University of Singapore

Status: Completed

Conditions: Aging; Cardiovascular Diseases

Treatments: Other: Healthy diet; Other: Wolfberry

Study type: Interventional

Funder types: Other

Identifiers

NCT03535844

S2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups

Wolfberry with healthy diet

Experimental group

Description:

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.

Treatment:

Other: Wolfberry

Other: Healthy diet

Healthy diet

Active Comparator group

Description:

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.

Treatment:

Other: Healthy diet