Clinical trial NCT03535844: Cardio-vascular Protective Effects of Wolfberry in Middle-aged and Older Adults
Official title: Cardio-vascular Protective Effects of Wolfberry in Middle-aged and Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Aging
Keywords: Wolfberry (Goji berry)
Healthy diet
Cardiovascular diseases
Endothelial function
Lipidomics
Middle-aged and older adults
Oxidative stress
Inflammation
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: National University Hospital, Singapore
name: Ministry of Education, Singapore
First posted: 2018-05-24
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Lipidomic Profiles
timeFrame: Pre- and post-intervention (Week 16)
measure: Change in Carotid Intima Media Thickness
timeFrame: Pre- and post-intervention (Week 16)
measure: Change in Endothelial Progenitor Cells
timeFrame: Pre- and post-intervention (Week 16)
measure: Change in Flow Mediated Dilation
timeFrame: Pre- and post-intervention (Week 16)
measure: Change in Plasma Nitric Oxide
timeFrame: Pre- and post-intervention (Week 16)
measure: Change in Blood Carotenoid Status
timeFrame: Pre- and post-intervention (Week 16)
measure: Change in Plasma Endothelin-1
timeFrame: Pre- and post-intervention (Week 16)
measure: Change in Plasma ICAM-1
timeFrame: Pre- and post-intervention (Week 16)
Secondary outcomes:
measure: Change in Blood Lipid-lipoprotein Concentrations
timeFrame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
measure: Change in Blood Pressure
timeFrame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
measure: Change in Oxidative Stress-related Biomarkers
timeFrame: Pre- and post-intervention (Week 16)
measure: Change in Body Composition
timeFrame: Pre- and post-intervention (Week 16)
measure: Change in Skin Carotenoid Status
timeFrame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
measure: Body Mass Index
timeFrame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
measure: Change in Waist Circumference
timeFrame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
measure: Change in Appetite
timeFrame: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported
measure: Dietary Carotenoids
timeFrame: Pre- and post-intervention (Week 16)
measure: Change in Sleep Quality
timeFrame: Pre- and post-intervention (Week 16)
measure: Change in Cognitive Function
timeFrame: Pre- and post-intervention (Week 16)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapaore
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University of Singapore
name: Jung Eun Kim, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.