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Completed

NCT Number: NCT03535844

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Wolfberry

Other

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

healthy diet

Other

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

Primary outcomes

  1. Change in Lipidomic Profiles

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

    The main classes of lipids in the cell membrane

  2. Change in Carotid Intima Media Thickness

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

    Carotid intima media thickness measured using high-frequency ultrasonographic imaging

  3. Change in Endothelial Progenitor Cells

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

    Quantity and quality of circulating endothelial progenitor cells

  4. Change in Flow Mediated Dilation

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

    Brachial artery flow mediated dilation measured using high-frequency ultrasonographic imaging

  5. 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.

  6. Change in Blood Carotenoid Status

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

    Fasting state plasma carotenoids using high performance liquid chromatography.

  7. Change in Plasma Endothelin-1

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

    Concentrations of plasma endothelin-1 using commercially available ELISA assay kits.

  8. 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.

Secondary outcomes

  1. 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

    Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and total triglyceride

  2. Change in Blood Pressure

    Time frame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported

    Both systolic and diastolic blood pressure

  3. Change in Oxidative Stress-related Biomarkers

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

    Concentrations of plasma biomarkers of oxidative stress.

  4. Change in Body Composition

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

    Dual-energy X-ray absorptiometry

  5. 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

    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

  6. Body Mass Index

    Time frame: 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)

  7. Change in Waist Circumference

    Time frame: 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

  8. Change in Appetite

    Time frame: 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)

  9. Dietary Carotenoids

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

    Analysis of dietary carotenoids using 3-day food records

  10. Change in Sleep Quality

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

    Measured using The Pittsburgh Sleep Quality Index (PSQI) and sleep evaluation questionnaire

  11. Change in Cognitive Function

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

    Measured using Montreal cognitive assessment (MOCA)

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Collaborators

  • Ministry of Education, Singapore
  • National University Hospital, Singapore

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 24, 2018
Registry last updated
Apr 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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