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| Name | Class |
|---|---|
| National University Hospital, Singapore | OTHER |
| Ministry of Education, Singapore | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wolfberry | Other | Consumption of cooked dehydrated wolfberry as part of a mixed meal. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung Eun Kim, PhD, RD | National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Singapaore | Singapore | 117546 | Singapore | |||
| National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28685012 | Background | 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. | |
| 15705234 | Background |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Apparently healthy middle-aged and older adults in Singapore
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Lipidomic Profiles | The main classes of lipids in the cell membrane | Not Posted | Sep 2020 | Pre- and post-intervention (Week 16) | Participants | ||||||||||
| Primary | Change in Carotid Intima Media Thickness | Carotid intima media thickness measured using high-frequency ultrasonographic imaging | Posted | Mean | Standard Deviation | mm | Pre- and post-intervention (Week 16) |
1 year
There is no known risk associated with the consumption of wolfberry or a healthy eating pattern diet according to earlier intervention studies of a similar nature
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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There are no limitations to this trial currently.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kim Jung Eun | National University of Singapore | +6565161136 | fstkje@nus.edu.sg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2019 | Mar 5, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 18, 2019 | Mar 5, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000072001 | Diet, Healthy |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Healthy diet | Other | Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board. |
|
| Change in Plasma ICAM-1 |
Concentrations of plasma intercellular adhesion molecule-1 using commercially available ELISA assay kits. |
| Pre- and post-intervention (Week 16) |
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) |
| Singapore |
| 119074 |
| Singapore |
| 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. |
| 33964853 | Derived | 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. |
| BG001 | 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. Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Use of prescription medication and/or supplements | Count of Participants | Participants |
|
|
|
|
|
| Primary | Change in Endothelial Progenitor Cells | Quantity and quality of circulating endothelial progenitor cells | Posted | Mean | Standard Deviation | cells | Pre- and post-intervention (Week 16) |
|
|
|
|
| Primary | Change in Flow Mediated Dilation | Brachial artery flow mediated dilation measured using high-frequency ultrasonographic imaging | Posted | Mean | Standard Deviation | % dilation | Pre- and post-intervention (Week 16) |
|
|
|
|
| Primary | Change in Plasma Nitric Oxide | Concentrations of plasma total nitrate/nitrite using commercially available ELISA assay kits. | Posted | Mean | Standard Deviation | nmol/mL | Pre- and post-intervention (Week 16) |
|
|
|
|
| Primary | Change in Blood Carotenoid Status | Fasting state plasma carotenoids using high performance liquid chromatography. | Posted | Mean | Standard Deviation | nmol/L | 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 | Posted | Mean | Standard Deviation | mmol/L | 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 | Posted | Mean | Standard Deviation | mmHg | 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. | Posted | Mean | Standard Deviation | uM | Pre- and post-intervention (Week 16) |
|
|
|
|
| Secondary | Change in Body Composition | Dual-energy X-ray absorptiometry | Posted | Mean | Standard Deviation | % Body Fat | 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 | Posted | Mean | Standard Deviation | score on a scale | 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) | Posted | Mean | Standard Deviation | kg/m^2 | 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 | Posted | Mean | Standard Deviation | cm | 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) | Posted | Mean | Standard Deviation | score on a scale | 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 | Posted | Mean | Standard Deviation | ug | Pre- and post-intervention (Week 16) |
|
|
|
|
| Secondary | Change in Sleep Quality | Measured using The Pittsburgh Sleep Quality Index (PSQI) and sleep evaluation questionnaire | Not Posted | Sep 2020 | Pre- and post-intervention (Week 16) | Participants |
| Secondary | Change in Cognitive Function | Measured using Montreal cognitive assessment (MOCA) | Not Posted | Sep 2020 | Pre- and post-intervention (Week 16) | Participants |
| Primary | Change in Plasma Endothelin-1 | Concentrations of plasma endothelin-1 using commercially available ELISA assay kits. | Posted | Mean | Standard Deviation | pg/mL | 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. | Posted | Mean | Standard Deviation | ng/mL | Pre- and post-intervention (Week 16) |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | 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. Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board. | 0 | 18 | 0 | 18 | 0 | 18 |
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| 0.8203 |
| Superiority |
| t-test, 2 sided | Paired t-test of change values | 0.3882 | Superiority |
| 0.07 |
| Superiority |
| t-test, 2 sided | Paired t-test of Week 0 and Week 16 nitric oxide values | <0.05 | Superiority |
| TC Week 0 |
|
| TC Week 16 |
|
| LDL Week 0 |
|
| LDL Week 16 |
|
| HDL Week 0 |
|
| HDL Week 16 |
|
| 0.1393 |
| Superiority |
| t-test, 2 sided | Independent t-test of change LDL cholesterol values | 0.2221 | Superiority |
| t-test, 2 sided | Independent t-test of change HDL cholesterol values | 0.078 | Superiority |
| t-test, 2 sided | Paired t-test of Week 0 and Week 16 HDL cholesterol values | <0.05 | Superiority |
| t-test, 2 sided | Paired t-test of Week 0 and Week 16 HDL cholesterol values | 0.7261 | Superiority |
| Diastolic Week 0 |
|
| Diastolic Week 16 |
|
| 0.916 |
| Superiority |
| 0.07 |
| Superiority |
| t-test, 2 sided | 0.005 | Paired t-test between Week 0 and Week 16 endothelin-1 concentrations | Superiority |