Effect of Intake of Dehydrated Nopal Powder From Highly Mature Cladodes on the Lipid Profile

June 4, 2025 updated by: Maria de los Angeles Aguilera Barreiro, Universidad Autonoma de Queretaro

Effect of Intake of Dehydrated Nopal Powder From Highly Mature Cladodes (Opuntia Ficus-indica) on the Lipid Profile of Overweight or Obese Adults. A Randomized Controlled Trial.

Background: Opuntia ficus-indica is a plant from the cactus family (Cactaceae) that is widespread and of great economic importance in Mexico. It has been consumed as food since pre-Hispanic times and is currently considered a nutraceutical. In this study, the effect of consumption of dehydrated nopal powder from highly mature cladodes (Opuntia ficus-indica) on the lipid profile of overweight or obese patients diagnosed with dyslipidemia was investigated. Methods: A 3-month prospective clinical trial was conducted in 35 overweight or obese patients with dyslipidemia. The sample was divided into three groups with a daily intake of 30 g of dietary fiber: Group I received 5 g of dehydrated Opuntia ficus-indica cladodes plus the standard normocaloric diet for dyslipidemia, Group II received 15 g plus the diet, and Group III followed only the diet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Queretaro
      • Juriquilla, Queretaro, Mexico, 76230
        • Autonomous University of Queretaro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants with dyslipidemia, confirmed by lipid meas-urement in blood chemistry
  • overweight or obesity
  • A cardiovascular risk factor associated with abdominal obesity

Exclusion Criteria:

  • Patients with a suspected diagnosis of primary dyslipidemia
  • Diabetes
  • Hypertension
  • Thyroid disease were excluded from the study
  • Patients with complex or severe disease such as heart failure, liver or kidney disease
  • Pregnant or lactating women
  • Indidividuals taking lipid-modifying drugs or hormone replacement therapy - Patients with gastrointestinal problems and deficiencies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I (first arm): 5 g of dehydrated nopal + normocaloric diet.
Supplementation: 5 g of dehydrated nopal (2.47 g of fiber per day), reconstituted in water, taken before breakfast. Diet: 27.53 g of fiber per day, Normocaloric diet: Carbohydrates: 55%, Lipids 25% and Proteins 20%
Dietary supplement: supplementation with 5 g dehydrated nopal powder from highly mature cladodes
Group I received 5 g of dehydrated Opuntia ficus-indica cladodes plus the standard normocaloric diet for dyslipidemia.
Active Comparator: Group II (second arm): 15 g of dehydrated nopal + normocaloric diet.
Supplementation: 15 g of dehydrated nopal (7.42 g of fiber per day), reconstituted in water, taken before breakfast and at night. Diet: 22.58 g of fiber per day, Normocaloric diet: Carbohydrates 55%, Lipids 25% and Proteins 20%
Dietary supplement: supplementation with 15 g dehydrated nopal powder from highly mature cladodes
Group II received 15 g plus the diet, and Group III followed only the diet.
Other: Group III (third arm): normocaloric diet only (control or comparison group).
No dehydrated nopal or placebo. 30 g of fiber per day Normocaloric diet Carbohydrates 55%, Lipids 25% and Proteins 20%
Other: Control Group (only diet)
No dehydrated nopal or placebo. Diet: 30 g of fiber per day Normocaloric diet Carbohydrates 55%, Lipids 25% and Proteins 20%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood lipid levels
Time Frame: From enrollment to the end of treatment at 12 weeks
A blood sample (3 ml) was taken from the patients after fasting for 12 hours, then prepared for subsequent analysis by an enzymatic method. The Clinical 50 VWR cen-trifuge ® was used for sample preparation and the Roche Cobas C 111 ® kit for lipid analysis of the samples. These analyses were performed in duplicate. Comparison of supplementation with dehydrated nopal powder from highly mature cladodes, by group, in initial and final values of the lipid profile: Total cholesterol; LDL, Low-density lipoproteins; HDL, High-density lipoproteins; TGL, Tri-glycerides.
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Queretaro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

December 15, 2018

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

May 25, 2025

First Submitted That Met QC Criteria

June 4, 2025

First Posted (Actual)

June 13, 2025

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCN-10310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe