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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Aging
• Intervention / Treatment: Other: Wolfberry; Other: Healthy diet

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 117546
    • National University of Singapaore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wolfberry with 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.	Other: Wolfberry; Consumption of cooked dehydrated wolfberry as part of a mixed meal.; Other: Healthy diet; Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
Active Comparator: 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.	Other: Healthy diet; Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: National University of Singapore
• Collaborators: National University Hospital, Singapore; Ministry of Education, Singapore
• Investigators: Principal Investigator: Jung Eun Kim, PhD, RD, National University of Singapore

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1079/bjn20041284.
• Toh DWK, Xia X, Sutanto CN, Low JHM, Poh KK, Wang JW, Foo RS, Kim JE. Enhancing the cardiovascular protective effects of a healthy dietary pattern with wolfberry (Lycium barbarum): A randomized controlled trial. Am J Clin Nutr. 2021 Jul 1;114(1):80-89. doi: 10.1093/ajcn/nqab062. Erratum In: Am J Clin Nutr. 2021 Jul 1;114(1):397.

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2018
• Primary Completion (Actual): September 26, 2019
• Study Completion (Actual): September 26, 2019

Study Registration Dates

• First Submitted: April 22, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 13, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Oxidative stress; Inflammation; Endothelial function; Cardiovascular diseases; Lipidomics; Middle-aged and older adults; Healthy diet; Wolfberry (Goji berry)
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: S2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Electronic copies of the data with identifiable participant information will be kept on a secure website with access limited to the principal investigator and her research staff. All data will be de-identified prior to statistical analyses

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No