OverweightNCT07018908
Effect of Intake of Dehydrated Nopal Powder From Highly Mature Cladodes on the Lipid Profile
A study testing supplementation with 5 g dehydrated nopal powder from highly mature cladodes and supplementation with 15 g dehydrated nopal powder from highly mature cladodes in people with Overweight and Obesity, run by Universidad Autónoma de Querétaro at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Overweight, Obesity, Dyslipidemia
- What is being tested?
- supplementation with 5 g dehydrated nopal powder from highly mature cladodes and supplementation with 15 g dehydrated nopal powder from highly mature cladodes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jun 2018to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with dyslipidemia, confirmed by lipid meas-urement in blood chemistry
- overweight or obesity
- A cardiovascular risk factor associated with abdominal obesity
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Overweight, Obesity, Dyslipidemia
- Being tested
- supplementation with 5 g dehydrated nopal powder from highly mature cladodes, supplementation with 15 g dehydrated nopal powder from highly mature cladodes, Control Group (only diet)
- Keywords
- Opuntia ficus-indica, dyslipidemia, overweight, obesity, diet
- Medical subject headings
- Overweight, Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplementation with 5 g dehydrated nopal powder from highly mature cladodesDietary supplement
Group I received 5 g of dehydrated Opuntia ficus-indica cladodes plus the standard normocaloric diet for dyslipidemia.
supplementation with 15 g dehydrated nopal powder from highly mature cladodesDietary supplement
Group II received 15 g plus the diet, and Group III followed only the 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%
| Study group | Role | What they receive |
|---|---|---|
| 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% Receives: 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% Receives: 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% Receives: Other: Control Group (only diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Jun 2018
- Primary completion15 Dec 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma de Querétaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria de los Angeles Aguilera Barreiro, Universidad Autónoma de Querétaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018908
- Sponsor's protocol ID
- FCN-10310
- Status last verified
- Jun 2025
- First submitted
- 25 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07018908
- Acronym / sponsor ID
- FCN-10310
- Conditions
- Overweight, Obesity, Dyslipidemia
- Keywords
- Opuntia ficus-indica, dyslipidemia, overweight, obesity, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidad Autónoma de QuerétaroUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group I (first arm): 5 g of dehydrated nopal + normocaloric diet. | Active comparator | Dietary Supplement: supplementation with 5 g dehydrated nopal powder from highly mature cladodesSupplementation: 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 II (second arm): 15 g of dehydrated nopal + normocaloric diet. | Active comparator | Dietary Supplement: supplementation with 15 g dehydrated nopal powder from highly mature cladodesSupplementation: 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 III (third arm): normocaloric diet only (control or comparison group). | Other | Other: Control Group (only diet)No dehydrated nopal or placebo. 30 g of fiber per day Normocaloric diet Carbohydrates 55%, Lipids 25% and Proteins 20% |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants with dyslipidemia, confirmed by lipid meas-urement in blood chemistry
- overweight or obesity
- A cardiovascular risk factor associated with abdominal obesity
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supplementation with 5 g dehydrated nopal powder from highly mature cladodesGroup I received 5 g of dehydrated Opuntia ficus-indica cladodes plus the standard normocaloric diet for dyslipidemia. | Dietary supplement | Group I (first arm): 5 g of dehydrated nopal + normocaloric diet. |
| supplementation with 15 g dehydrated nopal powder from highly mature cladodesGroup II received 15 g plus the diet, and Group III followed only the diet. | Dietary supplement | Group II (second arm): 15 g of dehydrated nopal + normocaloric diet. |
| 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% | Other | Group III (third arm): normocaloric diet only (control or comparison group). |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supplementation with 5 g dehydrated nopal powder from highly mature cladodes and supplementation with 15 g dehydrated nopal powder from highly mature cladodes in people with Overweight and Obesity, run by Universidad Autónoma de Querétaro at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood lipid levels (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.