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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03535844

Enrollment

Registered

2018-05-24

Start date

2018-08-06

Completion date

2019-09-26

Last updated

2020-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Cardiovascular Diseases

Keywords

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

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.

Interventions

OTHERWolfberry

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

OTHERHealthy diet

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Dietary Carotenoids	Pre- and post-intervention (Week 16)	Analysis of dietary carotenoids using 3-day food records
Change in Blood Lipid-lipoprotein Concentrations	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
Change in Cognitive Function	Pre- and post-intervention (Week 16)	Measured using Montreal cognitive assessment (MOCA)
Change in Sleep Quality	Pre- and post-intervention (Week 16)	Measured using The Pittsburgh Sleep Quality Index (PSQI) and sleep evaluation questionnaire
Change in Blood Pressure	Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported	Both systolic and diastolic blood pressure
Change in Oxidative Stress-related Biomarkers	Pre- and post-intervention (Week 16)	Concentrations of plasma biomarkers of oxidative stress.
Change in Body Composition	Pre- and post-intervention (Week 16)	Dual-energy X-ray absorptiometry
Change in Skin Carotenoid Status	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
Body Mass Index	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)
Change in Waist Circumference	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
Change in Appetite	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)

Countries

Singapore

Participant flow

Participants by arm

Arm	Count
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.	22
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.	18
Total	40

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Wolfberry With Healthy Diet	Healthy Diet	Total
Age, Continuous	55 years STANDARD_DEVIATION 4	56 years STANDARD_DEVIATION 4	56 years STANDARD_DEVIATION 4
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	22 Participants	17 Participants	39 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	1 Participants	1 Participants
Region of Enrollment Singapore	22 Participants	18 Participants	40 Participants
Sex: Female, Male Female	18 Participants	11 Participants	29 Participants
Sex: Female, Male Male	4 Participants	7 Participants	11 Participants
Use of prescription medication and/or supplements	22 Participants	18 Participants	40 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 22	0 / 18
other Total, other adverse events	0 / 22	0 / 18
serious Total, serious adverse events	0 / 22	0 / 18

Outcome results

Primary

Change in Blood Carotenoid Status

Fasting state plasma carotenoids using high performance liquid chromatography.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Change in Blood Carotenoid Status	Week 0	2020.9 nmol/L	Standard Deviation 192.3
Wolfberry With Healthy Diet	Change in Blood Carotenoid Status	Week 16	1916.2 nmol/L	Standard Deviation 218.7
Healthy Diet	Change in Blood Carotenoid Status	Week 0	2746.3 nmol/L	Standard Deviation 224
Healthy Diet	Change in Blood Carotenoid Status	Week 16	1682.9 nmol/L	Standard Deviation 209.7

p-value: <0.05t-test, 2 sided

Primary

Change in Carotid Intima Media Thickness

Carotid intima media thickness measured using high-frequency ultrasonographic imaging

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Change in Carotid Intima Media Thickness	Week 0	0.67 mm	Standard Deviation 0.11
Wolfberry With Healthy Diet	Change in Carotid Intima Media Thickness	Week16	0.67 mm	Standard Deviation 0.12
Healthy Diet	Change in Carotid Intima Media Thickness	Week 0	0.60 mm	Standard Deviation 0.1
Healthy Diet	Change in Carotid Intima Media Thickness	Week16	0.70 mm	Standard Deviation 0.09

p-value: 0.49t-test, 2 sided

p-value: 0.5672t-test, 1 sided

p-value: 0.788t-test, 2 sided

Primary

Change in Endothelial Progenitor Cells

Quantity and quality of circulating endothelial progenitor cells

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Change in Endothelial Progenitor Cells	Week 0	9.89 cells	Standard Deviation 3.43
Wolfberry With Healthy Diet	Change in Endothelial Progenitor Cells	Week 16	9.64 cells	Standard Deviation 2.29
Healthy Diet	Change in Endothelial Progenitor Cells	Week 0	10.36 cells	Standard Deviation 2.67
Healthy Diet	Change in Endothelial Progenitor Cells	Week 16	9.46 cells	Standard Deviation 2.87

p-value: 0.67t-test, 2 sided

p-value: 0.8203t-test, 2 sided

p-value: 0.3882t-test, 2 sided

Primary

Change in Flow Mediated Dilation

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

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Change in Flow Mediated Dilation	Week 0	4.50 % dilation	Standard Deviation 3.24
Wolfberry With Healthy Diet	Change in Flow Mediated Dilation	Week 16	3.79 % dilation	Standard Deviation 2.68
Healthy Diet	Change in Flow Mediated Dilation	Week 0	3.95 % dilation	Standard Deviation 3.12
Healthy Diet	Change in Flow Mediated Dilation	Week 16	5.34 % dilation	Standard Deviation 2.49

p-value: 0.08t-test, 2 sided

Primary

Change in Lipidomic Profiles

The main classes of lipids in the cell membrane

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

Primary

Change in Plasma Endothelin-1

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

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Change in Plasma Endothelin-1	Endothelin1 Week 0	1.31 pg/mL	Standard Deviation 0.56
Wolfberry With Healthy Diet	Change in Plasma Endothelin-1	Endothelin1 Week 16	1.11 pg/mL	Standard Deviation 0.48
Healthy Diet	Change in Plasma Endothelin-1	Endothelin1 Week 0	1.19 pg/mL	Standard Deviation 0.6
Healthy Diet	Change in Plasma Endothelin-1	Endothelin1 Week 16	1.04 pg/mL	Standard Deviation 0.51

p-value: 0.7052t-test, 2 sided

p-value: 0.07t-test, 2 sided

p-value: 0.005t-test, 2 sided

Primary

Change in Plasma ICAM-1

Concentrations of plasma intercellular adhesion molecule-1 using commercially available ELISA assay kits.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Change in Plasma ICAM-1	ICAM-1 Week 16	7.43 ng/mL	Standard Deviation 2.43
Wolfberry With Healthy Diet	Change in Plasma ICAM-1	ICAM-1 Week 0	7.4 ng/mL	Standard Deviation 2.33
Healthy Diet	Change in Plasma ICAM-1	ICAM-1 Week 0	7.1 ng/mL	Standard Deviation 2.52
Healthy Diet	Change in Plasma ICAM-1	ICAM-1 Week 16	7.14 ng/mL	Standard Deviation 2.25

p-value: 0.9426t-test, 2 sided

Primary

Change in Plasma Nitric Oxide

Concentrations of plasma total nitrate/nitrite using commercially available ELISA assay kits.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Change in Plasma Nitric Oxide	Nitric oxide Week 0	15.91 nmol/mL	Standard Deviation 8.39
Wolfberry With Healthy Diet	Change in Plasma Nitric Oxide	Nitric oxide Week 16	19.38 nmol/mL	Standard Deviation 10.12
Healthy Diet	Change in Plasma Nitric Oxide	Nitric oxide Week 0	14.53 nmol/mL	Standard Deviation 6.8
Healthy Diet	Change in Plasma Nitric Oxide	Nitric oxide Week 16	19.55 nmol/mL	Standard Deviation 8.27

p-value: 0.7162t-test, 2 sided

p-value: 0.07t-test, 2 sided

p-value: <0.05t-test, 2 sided

Secondary

Body Mass Index

(body mass) divided by (height x height)

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Body Mass Index	Week 0	22.7 kg/m^2	Standard Deviation 3.7
Wolfberry With Healthy Diet	Body Mass Index	Week 16	22.7 kg/m^2	Standard Deviation 3.7
Healthy Diet	Body Mass Index	Week 0	22.8 kg/m^2	Standard Deviation 2.5
Healthy Diet	Body Mass Index	Week 16	22.9 kg/m^2	Standard Deviation 2.3

p-value: 0.9135t-test, 2 sided

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)

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Change in Appetite	Week 0	215 score on a scale	Standard Deviation 17
Wolfberry With Healthy Diet	Change in Appetite	Week 16	194 score on a scale	Standard Deviation 104
Healthy Diet	Change in Appetite	Week 0	209 score on a scale	Standard Deviation 64
Healthy Diet	Change in Appetite	Week 16	185 score on a scale	Standard Deviation 81

p-value: 0.9379t-test, 2 sided

Secondary

Change in Blood Lipid-lipoprotein Concentrations

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

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	TG Week 0	1.18 mmol/L	Standard Deviation 0.54
Wolfberry With Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	TG Week 16	1.15 mmol/L	Standard Deviation 0.52
Wolfberry With Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	TC Week 0	5.16 mmol/L	Standard Deviation 0.87
Wolfberry With Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	TC Week 16	5.30 mmol/L	Standard Deviation 0.88
Wolfberry With Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	LDL Week 0	3.06 mmol/L	Standard Deviation 0.63
Wolfberry With Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	LDL Week 16	3.14 mmol/L	Standard Deviation 0.6
Wolfberry With Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	HDL Week 0	1.56 mmol/L	Standard Deviation 0.49
Wolfberry With Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	HDL Week 16	1.65 mmol/L	Standard Deviation 0.47
Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	HDL Week 16	1.53 mmol/L	Standard Deviation 0.39
Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	TG Week 0	1.32 mmol/L	Standard Deviation 0.62
Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	LDL Week 0	3.23 mmol/L	Standard Deviation 1.1
Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	TG Week 16	1.36 mmol/L	Standard Deviation 0.73
Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	HDL Week 0	1.54 mmol/L	Standard Deviation 0.42
Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	TC Week 0	5.36 mmol/L	Standard Deviation 1.17
Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	LDL Week 16	3.16 mmol/L	Standard Deviation 1.11
Healthy Diet	Change in Blood Lipid-lipoprotein Concentrations	TC Week 16	5.31 mmol/L	Standard Deviation 1.16

p-value: 0.4855t-test, 2 sided

p-value: 0.1393t-test, 2 sided

p-value: 0.2221t-test, 2 sided

p-value: 0.078t-test, 2 sided

p-value: <0.05t-test, 2 sided

p-value: 0.7261t-test, 2 sided

Secondary

Change in Blood Pressure

Both systolic and diastolic blood pressure

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Change in Blood Pressure	Systolic Week 0	114 mmHg	Standard Deviation 18
Wolfberry With Healthy Diet	Change in Blood Pressure	Systolic Week 16	111 mmHg	Standard Deviation 15
Wolfberry With Healthy Diet	Change in Blood Pressure	Diastolic Week 0	72 mmHg	Standard Deviation 12
Wolfberry With Healthy Diet	Change in Blood Pressure	Diastolic Week 16	73 mmHg	Standard Deviation 10
Healthy Diet	Change in Blood Pressure	Diastolic Week 16	69 mmHg	Standard Deviation 7
Healthy Diet	Change in Blood Pressure	Systolic Week 0	106 mmHg	Standard Deviation 13
Healthy Diet	Change in Blood Pressure	Diastolic Week 0	69 mmHg	Standard Deviation 9
Healthy Diet	Change in Blood Pressure	Systolic Week 16	107 mmHg	Standard Deviation 13

p-value: 0.1951t-test, 2 sided

p-value: 0.916t-test, 2 sided

Secondary

Change in Body Composition

Dual-energy X-ray absorptiometry

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Change in Body Composition	% Body Fat Week 0	36.5 % Body Fat	Standard Deviation 6.9
Wolfberry With Healthy Diet	Change in Body Composition	% Body Fat Week 16	36.2 % Body Fat	Standard Deviation 7.4
Healthy Diet	Change in Body Composition	% Body Fat Week 0	35.1 % Body Fat	Standard Deviation 6.1
Healthy Diet	Change in Body Composition	% Body Fat Week 16	34.4 % Body Fat	Standard Deviation 7.4

p-value: 0.4408t-test, 2 sided

Secondary

Change in Cognitive Function

Measured using Montreal cognitive assessment (MOCA)

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

Secondary

Change in Oxidative Stress-related Biomarkers

Concentrations of plasma biomarkers of oxidative stress.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Change in Oxidative Stress-related Biomarkers	MDA Week 0	0.294 uM	Standard Deviation 0.021
Wolfberry With Healthy Diet	Change in Oxidative Stress-related Biomarkers	MDA Week 16	0.282 uM	Standard Deviation 0.021
Healthy Diet	Change in Oxidative Stress-related Biomarkers	MDA Week 0	0.327 uM	Standard Deviation 0.037
Healthy Diet	Change in Oxidative Stress-related Biomarkers	MDA Week 16	0.316 uM	Standard Deviation 0.025

p-value: 0.9882t-test, 2 sided

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

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Change in Skin Carotenoid Status	Week 0	33636 score on a scale	Standard Deviation 2724
Wolfberry With Healthy Diet	Change in Skin Carotenoid Status	Week 16	37879 score on a scale	Standard Deviation 2841
Healthy Diet	Change in Skin Carotenoid Status	Week 0	33713 score on a scale	Standard Deviation 1954
Healthy Diet	Change in Skin Carotenoid Status	Week 16	35426 score on a scale	Standard Deviation 2065

p-value: 0.1487t-test, 2 sided

Secondary

Change in Sleep Quality

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

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

Secondary

Change in Waist Circumference

Measurement of waist circumference using World Health Organization guidelines

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Change in Waist Circumference	Week 0	80.5 cm	Standard Deviation 9.6
Wolfberry With Healthy Diet	Change in Waist Circumference	Week 16	80.4 cm	Standard Deviation 9.6
Healthy Diet	Change in Waist Circumference	Week 0	22.9 cm	Standard Deviation 2.3
Healthy Diet	Change in Waist Circumference	Week 16	22.8 cm	Standard Deviation 2.5

p-value: 0.5859t-test, 2 sided

Secondary

Dietary Carotenoids

Analysis of dietary carotenoids using 3-day food records

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Wolfberry With Healthy Diet	Dietary Carotenoids	Week 0	8627.1 ug	Standard Deviation 1637.1
Wolfberry With Healthy Diet	Dietary Carotenoids	Week 16	10487.8 ug	Standard Deviation 1099.5
Healthy Diet	Dietary Carotenoids	Week 0	11087.4 ug	Standard Deviation 1708.3
Healthy Diet	Dietary Carotenoids	Week 16	12845.98 ug	Standard Deviation 1791.12

p-value: 0.9717t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026

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

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change in Blood Carotenoid Status

Change in Carotid Intima Media Thickness

Change in Endothelial Progenitor Cells

Change in Flow Mediated Dilation

Change in Lipidomic Profiles

Change in Plasma Endothelin-1

Change in Plasma ICAM-1

Change in Plasma Nitric Oxide

Body Mass Index

Change in Appetite

Change in Blood Lipid-lipoprotein Concentrations

Change in Blood Pressure

Change in Body Composition

Change in Cognitive Function

Change in Oxidative Stress-related Biomarkers

Change in Skin Carotenoid Status

Change in Sleep Quality

Change in Waist Circumference

Dietary Carotenoids