Vascular Health of Postmenopausal Women
Conditions
Brief summary
This study aimed to examine the effects of a one-time dose of 100% watermelon juice on circulating lycopene levels and measures of vascular health among a cohort of postmenopausal women.
Detailed description
Purpose and Objectives Arterial stiffness and endothelial dysfunction are early independent predictors of cardiovascular disease (CVD), the leading cause of death for women ages 60 and older in the United States. It is well-known that age-related decreases in vascular function are partially due to increases in oxidative stress and inflammation. In attempts to combat CVD, previous studies have investigated provision of isolated food compounds in supplement form. For example, purified lycopene has been shown to decrease oxidative stress, and our previous work supports the supplemental use of glutamine and arginine powders for improving vascular endothelial function of older adults. Watermelon is among the greatest plant sources of arginine and glutamine, and it is one of the richest sources of lycopene. However, clinical studies evaluating the whole food have not been done. According to the Healthy Eating Index, only 27% of women ages 60 and older meet the daily dietary recommendations for 2.5 fruit servings. Likewise, although no Recommended Dietary Allowance for lycopene exists, this age group consumes less lycopene daily than is provided in one serving of watermelon. While reasons for poor fruit intake among older adults are multifactorial, difficulty chewing and inability to prepare fresh foods in the home environment have been noted as significant barriers to fresh fruit and vegetable intake. Of note, a previous systematic review suggests that 100% fruit and vegetable juices may be practical vehicles for improving intake of antioxidant nutrients among older adults. The provision of 100% watermelon juice to older adult women represents a practical, innovative approach to increase consumption of a food containing multiple components that may act in synergy to improve vascular function. Therefore, the purpose of this study is to investigate the effects of a one-time serving of 100% watermelon juice on blood vessel function and serum lycopene. Specific Aims The specific aims of this study are to: 1. To determine whether consumption of a 12-ounce serving of 100% watermelon juice by non-obese women ages 60-75 will result in increased levels of serum lycopene. Hypotheses: Acute supplementation with 100% watermelon juice will result in increased serum lycopene. 2. To determine whether consumption of a 12-ounce serving of 100% watermelon juice by non-obese women ages 60-75 will result in improved vascular endothelial function as assessed by flow-mediated dilation (FMD) and decreased arterial stiffness as assessed by pulse wave analysis (PWA). Hypotheses: Acute supplementation with 100% watermelon juice will result in improved vascular endothelial function and decreased arterial stiffness.
Interventions
Participants consumed a one-time dose of 100% watermelon juice. Blood was sampled before and 2 hours after ingestion. Blood pressure and brachial artery flow-mediated dilation were measured before and 2 hours after ingestion.
Sponsors
University of Alabama, Tuscaloosa
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index 18.5 - 29.9 kg/m2 (non-obese) * Ambulatory * Postmenopausal female * Ages 65-70 years
Exclusion criteria
* Food allergy to watermelon * Diagnosis of phenylketonuria * History of hypotension, chronic uncontrolled hypertension, chronic kidney disease, diabetes, previous cardiac events or procedures, * Smoking or other tobacco use * Use of anticoagulant medications, cholesterol-lowering medications, vasodilatory dietary supplements (garlic, fish oil), or dietary supplements containing lycopene, ascorbic acid, L-glutamine, L-arginine, or L-citrulline * Weight change \> 10% in the previous six months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Circulating Lycopene Levels | 2 hours post-ingestion | On the testing day, participants reported to the clinic following a 10-hour overnight fast. Blood samples were obtained by standard venipuncture at baseline and two hours after ingestion of a 360 ml dose of 100% pasteurized watermelon juice in order to determine change in serum lycopene levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Endothelial-dependent Vasodilation | 2 hours post-ingestion | Brachial artery flow-mediated dilation (FMD) was used to assess endothelial-dependent vasodilation. FMD uses ultrasound technology to quantify changes in brachial artery diameter in response to hyperemia. A blood pressure cuff was placed distal to the brachial artery of the right arm with the participant supine and rested. Pre-inflation diameter was recorded for one minute, and the cuff was inflated to 50 mmHg above resting SBP for five minutes. Then, images were recorded for 120 seconds after cuff deflation. Peak diameter was determined as an average of the five highest measurements over five seconds post-deflation. FMD was expressed as the percentage increase in peak diameter. FMD measurements were taken at baseline and 2 hours after ingestion of the 100% watermelon juice. The outcome measure reflects change in FMD from baseline to 2 hours post-ingestion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Watermelon Juice All participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Blood sampling was not completed for 2 participants. | 2 |
| Overall Study | One participant chose not to consume the entire 12-ounce dose of watermelon juice. | 1 |
Baseline characteristics
| Characteristic | Watermelon Juice |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 65.73 years STANDARD_DEVIATION 2.28 |
| Flow-mediated dilation (FMD) | 9.93 percent change in diameter STANDARD_DEVIATION 6.09 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 11 Participants |
| Serum lycopene | 1.48 umol/L STANDARD_DEVIATION 1.07 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Change From Baseline in Circulating Lycopene Levels
On the testing day, participants reported to the clinic following a 10-hour overnight fast. Blood samples were obtained by standard venipuncture at baseline and two hours after ingestion of a 360 ml dose of 100% pasteurized watermelon juice in order to determine change in serum lycopene levels.
Time frame: 2 hours post-ingestion
Population: Eleven participants provided consent for the cross-sectional study. Blood sampling was not possible for two participants, and one participant did not consume the entire 12-ounce dose of juice.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Watermelon Juice | Change From Baseline in Circulating Lycopene Levels | 2.85 umol/L | Standard Deviation 0.66 |
Secondary
Change From Baseline in Endothelial-dependent Vasodilation
Brachial artery flow-mediated dilation (FMD) was used to assess endothelial-dependent vasodilation. FMD uses ultrasound technology to quantify changes in brachial artery diameter in response to hyperemia. A blood pressure cuff was placed distal to the brachial artery of the right arm with the participant supine and rested. Pre-inflation diameter was recorded for one minute, and the cuff was inflated to 50 mmHg above resting SBP for five minutes. Then, images were recorded for 120 seconds after cuff deflation. Peak diameter was determined as an average of the five highest measurements over five seconds post-deflation. FMD was expressed as the percentage increase in peak diameter. FMD measurements were taken at baseline and 2 hours after ingestion of the 100% watermelon juice. The outcome measure reflects change in FMD from baseline to 2 hours post-ingestion.
Time frame: 2 hours post-ingestion
Population: One participant did not consume the entire 12-ounce dose of juice.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Watermelon Juice | Change From Baseline in Endothelial-dependent Vasodilation | 2.33 percent change from baseline | Standard Deviation 7.33 |