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

NCT07018908 | Completed

• 1 other identifier: FCN-10310
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight; Obesity; Dyslipidemia

Keywords

Opuntia ficus-indica; dyslipidemia; overweight; obesity; diet

Outcome Measures

Primary Outcomes (1)

• Blood lipid levels

  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

Study Arms (3)

Group I (first arm): 5 g of dehydrated nopal + normocaloric diet.

ACTIVE COMPARATOR

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 II (second arm): 15 g of dehydrated nopal + normocaloric diet.

ACTIVE COMPARATOR

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 III (third arm): normocaloric diet only (control or comparison group).

OTHER

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)

Interventions

supplementation with 5 g dehydrated nopal powder from highly mature cladodes DIETARY_SUPPLEMENT

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

Group I (first arm): 5 g of dehydrated nopal + normocaloric diet.

supplementation with 15 g dehydrated nopal powder from highly mature cladodes DIETARY_SUPPLEMENT

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

Group II (second arm): 15 g of dehydrated nopal + normocaloric diet.

Control Group (only diet) OTHER

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

Group III (third arm): normocaloric diet only (control or comparison group).

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autónoma de Querétaro: lead

Study Sites (1)

Autonomous University of Queretaro

Juriquilla, Querétaro, 76230, Mexico

Location

MeSH Terms

Conditions

Overweight; Obesity; Dyslipidemias

Interventions

Dietary Supplements; Control Groups

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 13, 2025
• Study Start: June 1, 2018
• Primary Completion: December 15, 2018
• Study Completion: May 1, 2019
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)