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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535844
• Other study ID #: S2
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: September 26, 2019

Study information

• Verified date: April 2020
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 26, 2019
• Est. primary completion date: September 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cardiovascular Diseases

Intervention

Other:
• Wolfberry
Consumption of cooked dehydrated wolfberry as part of a mixed meal.
• Healthy diet
Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore
Singapore	National University of Singapaore	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
National University, Singapore	Ministry of Education, Singapore, National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Cheng CY, Chung WY, Szeto YT, Benzie IF. Fasting plasma zeaxanthin response to Fructus barbarum L. (wolfberry; Kei Tze) in a food-based human supplementation trial. Br J Nutr. 2005 Jan;93(1):123-30. — View Citation

de Souza Zanchet MZ, Nardi GM, de Oliveira Souza Bratti L, Filippin-Monteiro FB, Locatelli C. Lycium barbarum Reduces Abdominal Fat and Improves Lipid Profile and Antioxidant Status in Patients with Metabolic Syndrome. Oxid Med Cell Longev. 2017;2017:9763210. doi: 10.1155/2017/9763210. Epub 2017 Jun 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Lipidomic Profiles	The main classes of lipids in the cell membrane	Pre- and post-intervention (Week 16)
Primary	Change in Carotid Intima Media Thickness	Carotid intima media thickness measured using high-frequency ultrasonographic imaging	Pre- and post-intervention (Week 16)
Primary	Change in Endothelial Progenitor Cells	Quantity and quality of circulating endothelial progenitor cells	Pre- and post-intervention (Week 16)
Primary	Change in Flow Mediated Dilation	Brachial artery flow mediated dilation measured using high-frequency ultrasonographic imaging	Pre- and post-intervention (Week 16)
Primary	Change in Plasma Nitric Oxide	Concentrations of plasma total nitrate/nitrite using commercially available ELISA assay kits.	Pre- and post-intervention (Week 16)
Primary	Change in Blood Carotenoid Status	Fasting state plasma carotenoids using high performance liquid chromatography.	Pre- and post-intervention (Week 16)
Primary	Change in Plasma Endothelin-1	Concentrations of plasma endothelin-1 using commercially available ELISA assay kits.	Pre- and post-intervention (Week 16)
Primary	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	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
Secondary	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
Secondary	Change in Oxidative Stress-related Biomarkers	Concentrations of plasma biomarkers of oxidative stress.	Pre- and post-intervention (Week 16)
Secondary	Change in Body Composition	Dual-energy X-ray absorptiometry	Pre- and post-intervention (Week 16)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Dietary Carotenoids	Analysis of dietary carotenoids using 3-day food records	Pre- and post-intervention (Week 16)
Secondary	Change in Sleep Quality	Measured using The Pittsburgh Sleep Quality Index (PSQI) and sleep evaluation questionnaire	Pre- and post-intervention (Week 16)
Secondary	Change in Cognitive Function	Measured using Montreal cognitive assessment (MOCA)	Pre- and post-intervention (Week 16)