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

Not Applicable

Completed

• Conditions: Aging; Cardiovascular Diseases
• Interventions: Other: Wolfberry; Other: Healthy diet

• Registration Number: NCT03535844
• Lead Sponsor: National University of Singapore

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-04-22
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-24
• Study Start: 2018-08-06
• Primary Completion: 2019-09-26
• Study Completion: 2019-09-26
• Results First Submitted: 2020-03-06
• Results First Submitted QC: 2020-03-19
• Status Verified: 2020-04
• Results First Posted: 2020-04-01
• Last Update Submitted: 2020-04-13
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wolfberry with healthy diet	Wolfberry	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.
Wolfberry with healthy diet	Healthy diet	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.
Healthy diet	Healthy diet	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Blood Lipid-lipoprotein Concentrations	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
Change in Blood Pressure	Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported	Both systolic and diastolic blood pressure
Change in Oxidative Stress-related Biomarkers	Pre- and post-intervention (Week 16)	Concentrations of plasma biomarkers of oxidative stress.
Change in Body Composition	Pre- and post-intervention (Week 16)	Dual-energy X-ray absorptiometry
Change in Skin Carotenoid Status	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
Body Mass Index	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)
Change in Waist Circumference	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
Change in Appetite	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)
Dietary Carotenoids	Pre- and post-intervention (Week 16)	Analysis of dietary carotenoids using 3-day food records
Change in Sleep Quality	Pre- and post-intervention (Week 16)	Measured using The Pittsburgh Sleep Quality Index (PSQI) and sleep evaluation questionnaire
Change in Cognitive Function	Pre- and post-intervention (Week 16)	Measured using Montreal cognitive assessment (MOCA)

Trial Locations

Locations (2)

National University of Singapaore; 🇸🇬 Singapore, Singapore

National University Hospital; 🇸🇬 Singapore, Singapore