Effect of Consumption of Chaya on Lipid Concentration and Antioxidant Status of Patients With Dyslipidemia

NCT04110392 | Completed

• 1 other identifier: 2018-030
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, the changes generated in lifestyle, such as excessive consumption of saturated fats and refined carbohydrates, as well as the decrease in the intake of fiber, fruits, vegetables and antioxidants, as well as physical inactivity, have generated an increase in the prevalence of dyslipidemias. Dyslipidemias are a disorder of blood lipid and lipoprotein concentration, which increases the risk of developing atherosclerosis and cardiovascular diseases. In Mexico, the dyslipidemias are present in one in four Mexicans over 20 years old. However, in Yucatan increases this frequency increases due to one in three people suffer from dyslipidemia. Its prevalence is even higher in overweight subjects, diabetes and high blood pressure. Thus, it is important to search for strategies to reduce dyslipidemias, as well as the complications associated with them. The treatment and prevention of dyslipidemia is through dietary treatment, which may be accompanied by the consumption of foods that generate beneficial health effects due to the presence of bioactive compounds. Chaya (Cnidoscolus chayamansa) is a plant use in popular medicine to treat medicine in the treatment of chronic degenerative diseases. It contained different bioactive compounds such as flavonoids, vitamin C and polyphenols such as quercetin and kaempferol. Compounds that have been assigned various beneficial effects such as decreased triglyceride concentrations, cholesterol, malondialdehyde, C-Reactive protein, oxidized LDL, which are alterations that are present in dyslipidemia. Therefore, the consumption of this food could be an adequate strategy for subjects with dyslipidemia in Yucatan and Mexico due to the anti-inflammatory and antioxidant effects, and could reduce the risk of developing atherosclerosis and cardiovascular diseases.

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (2)

• Change from baseline triglycerides concentration at 6 weeks of intervention

  Serum triglyceride measurement by the method of colorimetry enzymatic

  At the beginning of the study and after 6 weeks of intervention

• Change from baseline Lipoproteins concentration at 6 weeks of intervention

  Total cholesterol, LDL and HDL measurement by the method of colorimetry enzymatic

  At the beginning of the study and after 6 weeks of intervention

Secondary Outcomes (4)

• Change from baseline blood gene expression of superoxide dismutase at 6 weeks of intervention

  At the beginning of the study and after 6 weeks of intervention

• Change from baseline blood gene expression of catalase at 6 weeks of intervention

  At the beginning of the study and after 6 weeks of intervention

• Change from baseline serum antioxidant activity at 6 weeks of intervention

  At the beginning of the study and after 6 weeks of intervention

• Change from baseline serum C-Reactive Protein at 6 weeks of intervention

  At the beginning of the study and after 6 weeks of intervention

Study Arms (1)

Chaya (Cnidoscolus chayamansa)

EXPERIMENTAL

Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be treated with a commercial brand disinfectant following the manufacturer's instructions for use, then added 1L of purified water and mixed in blender. Finally, 500 mL of it will be placed in bottles. Participants will be instructed to consume 1 bottle per day for 6 weeks. 7 bottles will be delivered at each visit, which will be consumed during the week; participants will be instructed to keep the water refrigerated until it is consumed.

Dietary Supplement: Chaya (Cnidoscolus chayamansa)

Interventions

Chaya (Cnidoscolus chayamansa) DIETARY_SUPPLEMENT

Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be treated with a commercial brand disinfectant following the manufacturer's instructions for use, then added 1L of purified water and mixed in blender. Finally, 500 mL of it will be placed in bottles. Participants will be instructed to consume 1 bottle per day for 6 weeks. 7 bottles will be delivered at each visit, which will be consumed during the week; participants will be instructed to keep the water refrigerated until it is consumed.

Chaya (Cnidoscolus chayamansa)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female.
• Adults between 20 and 60 years.
• BMI ≥ 20 and ≤ 39.9 kg / m².
• Mestizo Mexicans: parents and grandparents born in Mexico.
• Patients diagnosed with dyslipidemia.
• Dyslipidemia will be defined by any? alteration in the concentrations of the following lipoproteins: LDL cholesterol\> 130mg/dL or total cholesterol\> 200 mg/dL or triglycerides\> 150 mg/dL
• Patients should know how to read and write.
• Signature of informed consent.

You may not qualify if:

• Patients with any type of diabetes previously diagnosed
• Patients with acquired diseases that produce secondary obesity and diabetes.
• Patients who have suffered a cardiovascular event.
• Weight loss\> 3 kg in the last 3 months.
• Catabolic diseases such as cancer and acquired immunodeficiency syndrome.
• Positive smoking.
• Drug treatment:
• Antihypertensive drugs (thiacyclic, loop or potassium-sparing diuretics, angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers).

Sponsors & Collaborators

• Hospital Regional de Alta Especialidad de la Península de Yucatán: lead

Study Sites (1)

Hospital Regional de Alta Especialidad de la Península de Yucatán

Mérida, Yucatán, 97130, Mexico

Location

Related Publications (3)

• Garcia-Rodriguez RV, Gutierrez-Rebolledo GA, Mendez-Bolaina E, Sanchez-Medina A, Maldonado-Saavedra O, Dominguez-Ortiz MA, Vazquez-Hernandez M, Munoz-Muniz OD, Cruz-Sanchez JS. Cnidoscolus chayamansa Mc Vaugh, an important antioxidant, anti-inflammatory and cardioprotective plant used in Mexico. J Ethnopharmacol. 2014 Feb 3;151(2):937-43. doi: 10.1016/j.jep.2013.12.004. Epub 2013 Dec 11.

  PMID: 24333962 BACKGROUND

• Loarca-Pina G, Mendoza S, Ramos-Gomez M, Reynoso R. Antioxidant, antimutagenic, and antidiabetic activities of edible leaves from Cnidoscolus chayamansa Mc. Vaugh. J Food Sci. 2010 Mar;75(2):H68-72. doi: 10.1111/j.1750-3841.2009.01505.x.

  PMID: 20492237 BACKGROUND

• Kuti JO, Kuti HO. Proximate composition and mineral content of two edible species of Cnidoscolus (tree spinach). Plant Foods Hum Nutr. 1999;53(4):275-83. doi: 10.1023/a:1008081501857.

  PMID: 10540979 BACKGROUND

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Azalia Avila Nava, PhD

  Hospital Regional de Alta Especialidad de la Península de Yucatán

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher in medical sciences

Model Details: It is quasi-experimental and it was proposed before and after study, the study will be consisting of a pre-visit, 6 subsequent visits and a last visit to deliver results to the participant.

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 1, 2019
• Study Start: June 1, 2019
• Primary Completion: September 20, 2020
• Study Completion: December 7, 2020
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)