Effects of Nopales (Opuntia Spp.) on Lipoprotein Profile and Oxidative Stress in Moderately Hypercholesterolemic Adults

NCT02209493 | Completed

• 1 other identifier: Nopales-2014
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Disease

Keywords

Dietary intervention; Hypercholesterolemic adults; Vegetable intake; Functional food; Prevention

Outcome Measures

Primary Outcomes (1)

• Plasma lipids

  Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides.

  Pre- and post- each 2-week phase

Secondary Outcomes (3)

• Glucose

  Pre- and post- each 2-week phase

• Distribution of cholesterol in LDL and HDL subfractions

  After each 2-week phase

• Oxidized LDL

  Pre- and post- each 2-week phase

Other Outcomes (1)

• Vitamin C

  Pre- and post- each 2-week phase

Study Arms (2)

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

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

Behavioral: Food supplementation: cucumber

Interventions

Food supplementation: nopales BEHAVIORAL

Consumption of 2 cups/day of test food: nopales

Food supplementation: nopales

Food supplementation: cucumber BEHAVIORAL

Consumption of 2 cups/day of test food: cucumber

Food supplementation: cucumber

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate hypercholesterolemia (LDL cholesterol ≥ 120 mg/dL)

You may not qualify if:

• 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)
• Latex allergy
• Fear of needles
• Breastfeeding, pregnancy, or intent to become pregnant
• Unwillingness to comply with study protocol
• Participation in other research studies.

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Nutrition Laboratory at Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Sonia Vega-López, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 6, 2014
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: March 1, 2014
• Last Updated: August 7, 2014

Record last verified: 2014-08

Locations

US (1)