Cardiovascular DiseasesNCT03535844

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

A study testing Wolfberry and Healthy diet in people with Cardiovascular Diseases and Aging, run by National University of Singapore at 2 sites in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Cardiovascular Diseases, Aging
What is being tested?: Wolfberry and Healthy diet
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 2 sitesSingapore
Study dates: 6 Aug 2018to 26 Sep 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

2 sites in 1 country.

Singapore2 sites

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

Other trials in Singapore

About this study

Read the 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.

Conditions: Cardiovascular Diseases, Aging
Being tested: Wolfberry, Healthy diet
Keywords: Wolfberry (Goji berry), Healthy diet, Cardiovascular diseases, Endothelial function, Lipidomics, Middle-aged and older adults, Oxidative stress, Inflammation
Medical subject headings: Cardiovascular Diseases, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03535844
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Healthy diet

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (11)

Change in Blood Lipid-lipoprotein Concentrations
Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and total triglyceride
Measured: 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
Measured: 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.
Measured: Pre- and post-intervention (Week 16)
Change in Body Composition
Dual-energy X-ray absorptiometry
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: Pre- and post-intervention (Week 16)
Change in Sleep Quality
Measured using The Pittsburgh Sleep Quality Index (PSQI) and sleep evaluation questionnaire
Measured: Pre- and post-intervention (Week 16)
Change in Cognitive Function
Measured using Montreal cognitive assessment (MOCA)
Measured: Pre- and post-intervention (Week 16)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Aug 201826 Sep 2019

First posted24 May 2018
Study start6 Aug 2018
Primary completion26 Sep 2019
Study completion26 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
More trials run by National University of SingaporeThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03535844
Sponsor's protocol ID: S2
Status last verified: Apr 2020
First submitted: 22 Apr 2018
Last updated: 22 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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

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.
PubMed 28685012
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.
PubMed 15705234
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.
PubMed 33964853

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cardio-vascular Protective Effects of Wolfberry in Middle-aged and Older Adults
ClinicalTrials.gov ID: NCT03535844
Acronym / sponsor ID: S2
Conditions: Cardiovascular Diseases, Aging
Keywords: Wolfberry (Goji berry), Healthy diet, Cardiovascular diseases, Endothelial function, Lipidomics, Middle-aged and older adults, Oxidative stress, Inflammation
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: National University of SingaporeUniversity, hospital or other
Collaborators: National University Hospital, Singapore, Ministry of Education, Singapore
Study start: 6 Aug 2018 (actual)
Primary completion: 26 Sep 2019 (actual)
Study completion: 26 Sep 2019 (actual)
First posted: 24 May 2018 (actual)
Results: Posted 1 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Wolfberry with healthy diet	Experimental	Other: Wolfberry, Other: Healthy dietEach 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	Active comparator	Other: Healthy dietEach subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WolfberryConsumption of cooked dehydrated wolfberry as part of a mixed meal.	Other	Wolfberry with healthy diet
Healthy dietCompliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.	Other	Healthy diet, Wolfberry with healthy diet

Primary outcome

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

11 secondary outcomes

Change in Blood Lipid-lipoprotein Concentrations
Time frame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
Change in Blood Pressure
Time frame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
Change in Oxidative Stress-related Biomarkers
Time frame: Pre- and post-intervention (Week 16)
Change in Body Composition
Time frame: Pre- and post-intervention (Week 16)
Change in Skin Carotenoid Status
Time frame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
Body Mass Index
Time frame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
Change in Waist Circumference
Time frame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
Change in Appetite
Time frame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
Dietary Carotenoids
Time frame: Pre- and post-intervention (Week 16)
Change in Sleep Quality
Time frame: Pre- and post-intervention (Week 16)
Change in Cognitive Function
Time frame: Pre- and post-intervention (Week 16)

Results and safety

Results posted to the registry on 1 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Wolfberry With Healthy Diet	22	22
Healthy Diet	19	18

Primary outcome: Change in Lipidomic Profiles

Time frame: Pre- and post-intervention (Week 16)

The sponsor has not posted figures for this outcome.

Primary outcome: Change in Carotid Intima Media Thickness

Time frame: Pre- and post-intervention (Week 16). Mean (Standard Deviation). Unit: mm

Measure	Wolfberry With Healthy Diet n = 22	Healthy Diet n = 18
Week 0	0.67 (0.11)	0.60 (0.10)
Week16	0.67 (0.12)	0.70 (0.09)

Wolfberry With Healthy Diet vs Healthy Diet: p = 0.49, t-test, 2 sided
Healthy Diet: p = 0.5672, t-test, 1 sided
Wolfberry With Healthy Diet: p = 0.788, t-test, 2 sided

Primary outcome: Change in Endothelial Progenitor Cells

Time frame: Pre- and post-intervention (Week 16). Mean (Standard Deviation). Unit: cells

Measure	Wolfberry With Healthy Diet n = 22	Healthy Diet n = 18
Week 0	9.89 (3.43)	10.36 (2.67)
Week 16	9.64 (2.29)	9.46 (2.87)

Wolfberry With Healthy Diet vs Healthy Diet: p = 0.67, t-test, 2 sided
Healthy Diet: p = 0.8203, t-test, 2 sided
Wolfberry With Healthy Diet: p = 0.3882, t-test, 2 sided

Primary outcome: Change in Flow Mediated Dilation

Time frame: Pre- and post-intervention (Week 16). Mean (Standard Deviation). Unit: % dilation

Measure	Wolfberry With Healthy Diet n = 22	Healthy Diet n = 18
Week 0	4.50 (3.24)	3.95 (3.12)
Week 16	3.79 (2.68)	5.34 (2.49)

Wolfberry With Healthy Diet vs Healthy Diet: p = 0.08, t-test, 2 sided

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Wolfberry With Healthy Diet	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Healthy Diet	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Limitations and caveats (from the sponsor): There are no limitations to this trial currently.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28685012de 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.
Background: PubMed 15705234Cheng 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.
Derived from this study: PubMed 33964853Toh 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.
Individual participant dataSharing planned: No. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jung Eun Kim, PhD, RD principal investigator

National University of Singapore

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Wolfberry and Healthy diet in people with Cardiovascular Diseases and Aging, run by National University of Singapore at 2 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lipidomic Profiles (time frame: Pre- and post-intervention (Week 16)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03535844, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.