Cardiovascular DiseaseNCT02209493
Effects of Nopales (Opuntia Spp.) on Lipoprotein Profile and Oxidative Stress in Moderately Hypercholesterolemic Adults
A study testing Food supplementation: nopales and Food supplementation: cucumber in people with Cardiovascular Disease, run by Arizona State University at 1 site in United States.
Trial summary
In light of the high CVD morbidity and mortality, promoting simple interventions to improve serum lipids and decrease oxidative stress are warranted to help prevent chronic diseases. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Food supplementation: nopales and Food supplementation: cucumber
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderate hypercholesterolemia (LDL cholesterol ≥ 120 mg/dL)
Who cannot join
- Use of hypolipidemic medications
- Regular physical activity (≥ 30 min /day for ≥ 5 days/week)
- Presence of known chronic diseases (e.g., diabetes, CVD, cancer, hepatitis, inflammatory conditions, gastrointestinal disorders)
- Consumption of > 4 servings/day of fruits and vegetables
- Following a restrictive diet (e.g., carbohydrate restriction, veganism) or having any condition likely to require specialized dietary modifications
- Use of supplements (antioxidants, fiber and botanicals)
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- Latex allergy
- Fear of needles
- Breastfeeding, pregnancy, or intent to become pregnant
- Unwillingness to comply with study protocol
- Participation in other research studies.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nutrition Laboratory at Arizona State University
Phoenix, Arizona, 85004
About this study
Official title: The Efficacy of Nopales (Opuntia Spp.) on Lipoprotein Profile and Oxidative Stress Among Moderately Hypercholesterolemic Adults
In light of the high CVD morbidity and mortality, promoting simple interventions to improve serum lipids and decrease oxidative stress are warranted to help prevent chronic diseases. Because of their fiber content, nopales (prickly pear cactus pads from the Opuntia species) are commonly regarded among Mexicans as a medicinal plant for glycemic and cholesterol control. However, the literature documenting their purported hypocholesterolemic potential is scarce. Given the unique composition and potential benefits of nopales, their use may be an ideal approach as an adjunct therapy for the reduction in cardiometabolic risk factors. Therefore, the aim of this study is to evaluate the efficacy of a 2-week intervention with nopales pads for the reduction of established CVD risk factors (serum lipids) in comparison to a control food with lower antioxidant and fiber content (cucumber) among adults with moderate hypercholesterolemia in a randomized controlled crossover trial. Because limited data exists on the effects of nopales supplementation on other factors associated with cardiometabolic risk, an exploratory assessment of how biomarkers of insulin sensitivity, inflammation (high sensitivity C-reactive protein [hsCRP]) and oxidative stress (LDL oxidizability and total antioxidant capacity) will also be conducted.
Read the detailed description
In light of the high cardiovascular disease morbidity and mortality, promoting simple interventions to improve serum lipids and decrease oxidative stress are warranted to help prevent chronic diseases. Commonly prescribed dietary interventions for cardiovascular disease risk reduction include the use of functional foods known to have beneficial effects on risk factors.
Because of their fiber content, nopales (prickly pear cactus pads from the Opuntia species) are commonly regarded among Mexicans as a medicinal plant for glycemic and cholesterol control. However, the literature documenting their purported hypocholesterolemic potential is scarce. Most studies have focused on the prickly pear fruit, rather than the actual nopales cactus pads. Given the unique composition and potential benefits of nopales, their use may be an ideal approach as an adjunct therapy for the reduction in cardiometabolic risk factors.
The aim of this study is to evaluate the efficacy of a 2-week intervention with nopales pads for the reduction of established CVD risk factors (serum lipids) in comparison to a control food with lower antioxidant and fiber content (cucumber) among adults with moderate hypercholesterolemia in a randomized controlled crossover trial. Because limited data exists on the effects of nopales supplementation on other factors associated with cardiometabolic risk, an exploratory assessment of how biomarkers of insulin sensitivity, inflammation (high sensitivity C-reactive protein [hsCRP]) and oxidative stress (LDL oxidizability and total antioxidant capacity) will also be conducted.
In this randomized crossover trial, healthy adults with moderate hypercholesterolemia (LDL-cholesterol ≥ 120 mg/dL) but otherwise healthy will be randomly assigned to supplementation with 2 cups/day of nopales (300 g; intervention) or cucumbers (208 g; control), divided into two 1 cup daily doses with each of two main meals. After a 3-week washout period, each group will receive the alternative treatment for an additional 2 weeks. Participants will be asked to refrain from making any additional changes to their usual diet throughout the duration of the entire study.
Fasting blood samples will be collected at the beginning and end of each dietary intervention. At the beginning and end of each dietary intervention an additional fasting blood sample will be collected at least one day apart from the main blood collection day for measurement of serum lipids to account for day-to-day variability. Outcome measures include a complete lipid panel (total cholesterol, HDL-c, LDL-c, and triglycerides), fasting glucose, insulin, oxidized LDL and LDL susceptibility to oxidation, total antioxidant capacity (TAC), and vitamin C.
- Conditions
- Cardiovascular Disease
- Being tested
- Food supplementation: nopales, Food supplementation: cucumber
- Keywords
- Dietary intervention, Hypercholesterolemic adults, Vegetable intake, Functional food, Prevention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplementation: nopalesBehavioural
Consumption of 2 cups/day of test food: nopales
Food supplementation: cucumberBehavioural
Consumption of 2 cups/day of test food: cucumber
| Study group | Role | What they receive |
|---|---|---|
| Food supplementation: nopales | Experimental | Consumption of 2 cups/day of cooked nopales (prickly pear cactus leaves) with each of two main meals for 2 weeks Receives: Behavioral: Food supplementation: nopales |
| Food supplementation: cucumber | Sham comparator | Consumption of 2 cups/day peeled and chopped cucumber with each of two main meals for 2 weeks Receives: Behavioral: Food supplementation: cucumber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma lipids
Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides.
Measured: Pre- and post- each 2-week phase
Secondary outcomes (3)
Glucose
Plasma glucose
Measured: Pre- and post- each 2-week phase
Distribution of cholesterol in LDL and HDL subfractions
Distribution of cholesterol among seven LDL and ten HDL subfractions.
Measured: After each 2-week phase
Oxidized LDL
Amount of oxidized LDL as measured by ELISA and LDL oxidizability as measured by conjugated diene formation.
Measured: Pre- and post- each 2-week phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Vega-Lopez, Arizona State University
- Investigators
- Sonia Vega-López, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209493
- Sponsor's protocol ID
- Nopales-2014
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2014
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Nopales (Opuntia Spp.) on Lipoprotein Profile and Oxidative Stress Among Moderately Hypercholesterolemic Adults
- ClinicalTrials.gov ID
- NCT02209493
- Acronym / sponsor ID
- Nopales-2014
- Conditions
- Cardiovascular Disease
- Keywords
- Dietary intervention, Hypercholesterolemic adults, Vegetable intake, Functional food, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In light of the high CVD morbidity and mortality, promoting simple interventions to improve serum lipids and decrease oxidative stress are warranted to help prevent chronic diseases. Because of their fiber content, nopales (prickly pear cactus pads from the Opuntia species) are commonly regarded among Mexicans as a medicinal plant for glycemic and cholesterol control. However, the literature documenting their purported hypocholesterolemic potential is scarce. Given the unique composition and potential benefits of nopales, their use may be an ideal approach as an adjunct therapy for the reduction in cardiometabolic risk factors. Therefore, the aim of this study is to evaluate the efficacy of a 2-week intervention with nopales pads for the reduction of established CVD risk factors (serum lipids) in comparison to a control food with lower antioxidant and fiber content (cucumber) among adults with moderate hypercholesterolemia in a randomized controlled crossover trial. Because limited data exists on the effects of nopales supplementation on other factors associated with cardiometabolic risk, an exploratory assessment of how biomarkers of insulin sensitivity, inflammation (high sensitivity C-reactive protein [hsCRP]) and oxidative stress (LDL oxidizability and total antioxidant capacity) will also be conducted.
Detailed description
In light of the high cardiovascular disease morbidity and mortality, promoting simple interventions to improve serum lipids and decrease oxidative stress are warranted to help prevent chronic diseases. Commonly prescribed dietary interventions for cardiovascular disease risk reduction include the use of functional foods known to have beneficial effects on risk factors.
Because of their fiber content, nopales (prickly pear cactus pads from the Opuntia species) are commonly regarded among Mexicans as a medicinal plant for glycemic and cholesterol control. However, the literature documenting their purported hypocholesterolemic potential is scarce. Most studies have focused on the prickly pear fruit, rather than the actual nopales cactus pads. Given the unique composition and potential benefits of nopales, their use may be an ideal approach as an adjunct therapy for the reduction in cardiometabolic risk factors.
The aim of this study is to evaluate the efficacy of a 2-week intervention with nopales pads for the reduction of established CVD risk factors (serum lipids) in comparison to a control food with lower antioxidant and fiber content (cucumber) among adults with moderate hypercholesterolemia in a randomized controlled crossover trial. Because limited data exists on the effects of nopales supplementation on other factors associated with cardiometabolic risk, an exploratory assessment of how biomarkers of insulin sensitivity, inflammation (high sensitivity C-reactive protein [hsCRP]) and oxidative stress (LDL oxidizability and total antioxidant capacity) will also be conducted.
In this randomized crossover trial, healthy adults with moderate hypercholesterolemia (LDL-cholesterol ≥ 120 mg/dL) but otherwise healthy will be randomly assigned to supplementation with 2 cups/day of nopales (300 g; intervention) or cucumbers (208 g; control), divided into two 1 cup daily doses with each of two main meals. After a 3-week washout period, each group will receive the alternative treatment for an additional 2 weeks. Participants will be asked to refrain from making any additional changes to their usual diet throughout the duration of the entire study.
Fasting blood samples will be collected at the beginning and end of each dietary intervention. At the beginning and end of each dietary intervention an additional fasting blood sample will be collected at least one day apart from the main blood collection day for measurement of serum lipids to account for day-to-day variability. Outcome measures include a complete lipid panel (total cholesterol, HDL-c, LDL-c, and triglycerides), fasting glucose, insulin, oxidized LDL and LDL susceptibility to oxidation, total antioxidant capacity (TAC), and vitamin C.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food supplementation: nopales | Experimental | Behavioral: Food supplementation: nopalesConsumption of 2 cups/day of cooked nopales (prickly pear cactus leaves) with each of two main meals for 2 weeks |
| Food supplementation: cucumber | Sham comparator | Behavioral: Food supplementation: cucumberConsumption of 2 cups/day peeled and chopped cucumber with each of two main meals for 2 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate hypercholesterolemia (LDL cholesterol ≥ 120 mg/dL)
Key exclusion criteria (11 listed)
- Use of hypolipidemic medications
- Regular physical activity (≥ 30 min /day for ≥ 5 days/week)
- Presence of known chronic diseases (e.g., diabetes, CVD, cancer, hepatitis, inflammatory conditions, gastrointestinal disorders)
- Consumption of > 4 servings/day of fruits and vegetables
- Following a restrictive diet (e.g., carbohydrate restriction, veganism) or having any condition likely to require specialized dietary modifications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food supplementation: nopalesConsumption of 2 cups/day of test food: nopales | Behavioural | Food supplementation: nopales |
| Food supplementation: cucumberConsumption of 2 cups/day of test food: cucumber | Behavioural | Food supplementation: cucumber |
Primary outcome
Plasma lipids
Time frame: Pre- and post- each 2-week phase
Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides.
3 secondary outcomes
Glucose
Time frame: Pre- and post- each 2-week phase
Distribution of cholesterol in LDL and HDL subfractions
Time frame: After each 2-week phase
Oxidized LDL
Time frame: Pre- and post- each 2-week phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Vega-López, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food supplementation: nopales and Food supplementation: cucumber in people with Cardiovascular Disease, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma lipids (time frame: Pre- and post- each 2-week phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.