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

Universidad Autónoma de Querétaro

Status: Completed

Conditions: Overweight; Obesity; Dyslipidemia

Treatments: Other: Control Group (only diet); Dietary Supplement: supplementation with 5 g dehydrated nopal powder from highly mature cladodes; Dietary Supplement: supplementation with 15 g dehydrated nopal powder from highly mature cladodes

Study type: Interventional

Funder types: Other

Identifiers

NCT07018908

FCN-10310

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 3 patient groups

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

Active Comparator group

Description:

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%

Treatment:

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 group

Description:

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%

Treatment:

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 group

Description:

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

Treatment:

Other: Control Group (only diet)