DyslipidemiasPhase 2NCT05028699
Evaluation of Common Bean Baked Snack Consumption on Blood Lipids in Overweight People With Altered Blood Lipid Levels
A Phase 2 study testing Snack in people with Dyslipidemias, run by Centro Universitario de Ciencias de la Salud, Mexico at 1 site in Mexico.
Trial summary
Introduction: The Mexican population consumes vegetables and snacks with the same frequency. Besides, most of the snacks available on the market contain high fat, sodium and calorie, and low protein levels. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteMexico
- Study dates
- 3 May 2021to 10 Sep 2021
- Phase
- Phase 2
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI between 25.0 and 29.9 kg/m2,
- Abnormal serum lipid levels:
- Total cholesterol: ≥200 mg/dL,
- Low-density lipoproteins: 100 to 190 mg/dL,
- High-density lipoproteins: <50 mg/dL in females and <40 mg/dL in males,
- Triglycerides: 150 to 500 mg/dL.
Who cannot join
- Pregnancy or lactation,
- Plans to lose or gain weight in the next three months,
- Modification of diet or physical activity in the last three months,
- Diagnosis of diabetes, cancer, hypertension, heart disease, gastrointestinal disorder, pancreatitis, kidney, liver or thyroid disease,
- Smoking or drug use,
- Sensitivity for bean consumption,
- Pharmacological treatment or consumption of non-prescription drugs, herbal or nutritional supplements known to modify serum lipid levels.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
Guadalajara, Jalisco, 44340
About this study
Official title: Effect of Common Bean Baked Snack (Phaseolus Vulgaris L.) Consumption on Blood Lipid Levels and Hormones Regulating Appetite and Satiety: Randomized Crossover Clinical Trials
Introduction: The Mexican population consumes vegetables and snacks with the same frequency. Besides, most of the snacks available on the market contain high fat, sodium and calorie, and low protein levels. Regular consumption of these snacks and low physical activity could promote the development of noncommunicable diseases. Common bean-based snacks are potential healthier alternatives to replace conventional snacks.
Hypothesis: The consumption of a common bean baked snack (Phaseolus vulgaris L.) reduces blood lipid levels in overweight people with altered blood lipid levels.
Read more
Objectives: Evaluate the effect of common bean baked snack consumption on blood lipid levels in overweight people with altered blood lipid levels.
Material and Methods: Randomized crossover clinical trial, 28 patients with altered blood lipid levels, 18-40 years old, snack supplementation for four weeks, clinical and laboratory determinations, such as total cholesterol, triglycerides, LDL, HDL, among others.
- Intervention phase: Common bean baked snack intervention.
- Control phase B: No intervention.
- Conditions
- Dyslipidemias
- Being tested
- Snack
- Keywords
- Functional food, Common bean, Snack
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SnackOther
Participants will consume 32 g of a common bean baked snack per day for 28 days during the intervention stage.
| Study group | Role | What they receive |
|---|---|---|
| Snack | Experimental | 32 g of a common bean baked snack per day for 28 days. Receives: Other: Snack |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the mean low-density lipoprotein (mg/dL) at 28 days
Measured: Baseline and 28 days
Change from baseline in the mean high-density lipoprotein (mg/dL) at 28 days
Measured: Baseline and 28 days
Change from baseline in the mean total cholesterol (mg/dL) at 28 days
Measured: Baseline and 28 days
Change from baseline in the mean triglycerides (mg/dL) at 28 days
Measured: Baseline and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start3 May 2021
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco
- Responsible party
- Principal investigator, Alejandro Escobedo Avila, Centro Universitario de Ciencias de la Salud, Mexico
- Investigators
- Edgar A. Rivera León, PhD, Principal investigator, Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028699
- Sponsor's protocol ID
- CI-09620
- Status last verified
- Dec 2021
- First submitted
- 20 Aug 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Non-shareable data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Common Bean Baked Snack (Phaseolus Vulgaris L.) Consumption on Blood Lipid Levels and Hormones Regulating Appetite and Satiety: Randomized Crossover Clinical Trials
- ClinicalTrials.gov ID
- NCT05028699
- Acronym / sponsor ID
- CI-09620
- Conditions
- Dyslipidemias
- Keywords
- Functional food, Common bean, Snack
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, MexicoUniversity, hospital or other
- Collaborators
- Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco
- Study start
- 3 May 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 31 Aug 2021 (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.
Introduction: The Mexican population consumes vegetables and snacks with the same frequency. Besides, most of the snacks available on the market contain high fat, sodium and calorie, and low protein levels. Regular consumption of these snacks and low physical activity could promote the development of noncommunicable diseases. Common bean-based snacks are potential healthier alternatives to replace conventional snacks.
Hypothesis: The consumption of a common bean baked snack (Phaseolus vulgaris L.) reduces blood lipid levels in overweight people with altered blood lipid levels.
Objectives: Evaluate the effect of common bean baked snack consumption on blood lipid levels in overweight people with altered blood lipid levels.
Material and Methods: Randomized crossover clinical trial, 28 patients with altered blood lipid levels, 18-40 years old, snack supplementation for four weeks, clinical and laboratory determinations, such as total cholesterol, triglycerides, LDL, HDL, among others.
- Intervention phase: Common bean baked snack intervention.
- Control phase B: No intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Snack | Experimental | Other: Snack32 g of a common bean baked snack per day for 28 days. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- BMI between 25.0 and 29.9 kg/m2,
- Abnormal serum lipid levels:
Key exclusion criteria (7 listed)
- Pregnancy or lactation,
- Plans to lose or gain weight in the next three months,
- Modification of diet or physical activity in the last three months,
- Diagnosis of diabetes, cancer, hypertension, heart disease, gastrointestinal disorder, pancreatitis, kidney, liver or thyroid disease,
- Smoking or drug use,
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 |
|---|---|---|
| SnackParticipants will consume 32 g of a common bean baked snack per day for 28 days during the intervention stage. | Other | Snack |
Primary outcome
Change from baseline in the mean low-density lipoprotein (mg/dL) at 28 days
Time frame: Baseline and 28 days
Change from baseline in the mean high-density lipoprotein (mg/dL) at 28 days
Time frame: Baseline and 28 days
Change from baseline in the mean total cholesterol (mg/dL) at 28 days
Time frame: Baseline and 28 days
Change from baseline in the mean triglycerides (mg/dL) at 28 days
Time frame: Baseline and 28 days
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 10 Dec 2021.
- Individual participant dataSharing planned: No. Non-shareable data.
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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.
Edgar A. Rivera León, PhD principal investigator
Departamento de Biología Molecular y Genómica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Snack in people with Dyslipidemias, run by Centro Universitario de Ciencias de la Salud, Mexico 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 6 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 10 Dec 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in the mean low-density lipoprotein (mg/dL) at 28 days (time frame: Baseline and 28 days). The study lists 4 primary outcomes in all. 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 10 Dec 2021.