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

NCT ID: NCT07018908

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group I (first arm): 5 g of dehydrated nopal + normocaloric diet. Group II (second arm): 15 g of dehydrated nopal + normocaloric diet. Group III (third arm): normocaloric diet only (control or comparison group).

This design allows for the comparison of the effects of different doses or treatments (in this case, different amounts of nopal) against a control (the diet alone).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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%

Group Type ACTIVE_COMPARATOR

supplementation with 5 g dehydrated nopal powder from highly mature cladodes

Intervention Type DIETARY_SUPPLEMENT

Group I received 5 g of dehydrated Opuntia ficus-indica cladodes plus the standard normocaloric diet for dyslipidemia.

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%

Group Type ACTIVE_COMPARATOR

supplementation with 15 g dehydrated nopal powder from highly mature cladodes

Intervention Type DIETARY_SUPPLEMENT

Group II received 15 g plus the diet, and Group III followed only the diet.

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%

Group Type OTHER

Control Group (only diet)

Intervention Type OTHER

No dehydrated nopal or placebo. Diet: 30 g of fiber per day Normocaloric diet Carbohydrates 55%, Lipids 25% and Proteins 20%

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

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%

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Autónoma de Querétaro

OTHER

Sponsor Role lead

Responsible Party

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Maria de los Angeles Aguilera Barreiro

Director and Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Autonomous University of Queretaro

Juriquilla, Querétaro, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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FCN-10310

Identifier Type: -

Identifier Source: org_study_id

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