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

NCT03535844 | Completed Results

• 1 other identifier: S2
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Diseases; Aging

Keywords

Wolfberry (Goji berry); Healthy diet; Cardiovascular diseases; Endothelial function; Lipidomics; Middle-aged and older adults; Oxidative stress; Inflammation

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (11)

• Change in Blood Lipid-lipoprotein Concentrations

  Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported

• Change in 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

  Pre- and post-intervention (Week 16)

• Change in Body Composition

  Pre- and post-intervention (Week 16)

• Change in Skin Carotenoid Status

  Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported

Study Arms (2)

Wolfberry with healthy diet

EXPERIMENTAL

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; Other: Healthy diet

Healthy diet

ACTIVE COMPARATOR

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

Interventions

Wolfberry OTHER

Consumption of cooked dehydrated wolfberry as part of a mixed meal.

Wolfberry with healthy diet

Healthy diet OTHER

Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.

Healthy diet; Wolfberry with healthy diet

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to give an informed consent
• Age 50 to 75 years
• Willing to follow the study procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead
• National University Hospital, Singapore: collaborator
• Ministry of Education, Singapore: collaborator

Study Sites (2)

National University of Singapaore

Singapore, 117546, Singapore

Location

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (3)

• 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.

  PMID: 28685012 BACKGROUND

• 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.

  PMID: 15705234 BACKGROUND

• 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.

  PMID: 33964853 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Inflammation

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

There are no limitations to this trial currently.

Results Point of Contact

• Title: Dr. Kim Jung Eun
• Organization: National University of Singapore

fstkje@nus.edu.sg

+6565161136

Study Officials

• Jung Eun Kim, PhD, RD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 22, 2018
• First Posted: May 24, 2018
• Study Start: August 6, 2018
• Primary Completion: September 26, 2019
• Study Completion: September 26, 2019
• Last Updated: April 22, 2020
• Results First Posted: April 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)