ObesityPhase 3NCT06496100
Effect of Triticum Aestivum on Appetite, Ghrelin, Leptin, Adiponectin Hormonal Axis in Patients With Obesity
A Phase 3 study testing Triticum Aestivum in people with Obesity and Leptin Deficiency, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
Obesity represents one of the major health problems worldwide; it is clear that current approaches to address obesity are largely unsuccessful. The endocrine axis of leptin and ghrelin acts as the critical link between adipose tissue and hypothalamic centers that regulate food intake, satiety, energy expenditure and… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Leptin Deficiency, Ghrelin
- What is being tested?
- Triticum Aestivum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteMexico
- Study dates
- 3 Jan 2024to 24 Dec 2024
- Phase
- Phase 3
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- People of any sex (eumenorrheic women with mechanical or definitive contraceptive method without hormonal treatment).
- Age from 30 to 50 years old. Residents of the metropolitan area of Guadalajara. Signed informed consent form. People with a diagnosis of obesity (BMI ≥30 - 39.9 kg/m2), stable body weight within the 3 months prior to the start of the study.
Who cannot join
- Diagnosis of diabetes and dyslipidemia. Diagnosis of anxiety and/or depression. History of: liver disease, chronic kidney disease, thyroid disease, cancer. Antidiabetic treatment, lipid-lowering, food supplements, antidepressants, corticosteroids.
- Acute infectious processes Alcoholism and/or active smoking in any intensity within the 12 months prior to the start of the study.
- Suspected or confirmed pregnancy or breastfeeding. History of drug intake. Recent surgery (<3 months) Carrying a pacemaker, or any other bioelectronic or metallic element. Excessive sedentary lifestyle defined as physical activity less than the equivalent of 15 minutes of walking per day.
- Excessive exercise, defined as physical activity equivalent to running for 60 minutes per day.
- Intake of anorexigenic drugs, hypolipidemic drugs or drugs with effect on body weight.
- History of any type of cancer, hyperthyroidism, hypothyroidism, renal disease, liver disease and pancreatic disease.
- History of hypersensitivity to the study drug (gluten).
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Social Security Institute.
Guadalajara, Jalisco, 44380
Sandra O Hernández González, PhD, 52 3336170060 ext. 31494, dra_sandy2003@yahoo.com.mx
Miguel A Cardenas Sosa, MSPH, 52 3411703066, alejandrocs951127@hotmail.com
About this study
Official title: Effect of Triticum Aestivum on Appetite Regulation and the Ghrelin, Leptin, Adiponectin Hormonal Axis in Patients With Obesity
Obesity represents one of the major health problems worldwide; it is clear that current approaches to address obesity are largely unsuccessful. The endocrine axis of leptin and ghrelin acts as the critical link between adipose tissue and hypothalamic centers that regulate food intake, satiety, energy expenditure and weight.
Despite being a highly prevalent disease with major complications, current therapeutic options are not sufficient, as they are not ideal for the entire population. The importance of new pharmacological interventions that can be evaluated in the population at risk as an early form of treatment to avoid the development of chronic diseases with high morbidity and mortality.
Natural products such as Triticum aestivum and their high content of bioactive principles have been described for their pharmacokinetic functions in weight reduction, insulin resistance and modulation of neuropeptides involved in food intake.
Read the detailed description
A double-blind clinical trial is proposed, with two parallel groups, with random assignment and group control. The universe of the sample will be patients with a diagnosis of obesity, residents of the Guadalajara Metropolitan Area, who agree to participate by signing informed consent and can go to the Biomedical Unit 02 of the Mexican Institute of Social Security.
Two parallel groups, with randomization by software using envelopes, will require a total of 38 patients, which will be distributed as follows: 1) A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg capsules with lyophilized Triticum aestivum orally every 12 hours for 120 days, and 2) A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg capsules of placebo (calcined magnesia) orally every 12 hours for 120 days.
- Conditions
- Obesity, Leptin Deficiency, Ghrelin, Adiponectin
- Being tested
- Triticum Aestivum, Placebo (calcined magnesia)
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triticum AestivumDrug
The intervention period will be 120 days, looking for effects on appetite regulation and the hormonal axis Leptin, Ghrelin and Adiponectin.
Placebo (calcined magnesia)Drug
Also called Calcined magnesia
The intervention period will be 120 days, looking for effects on appetite regulation and the hormonal axis Leptin, Ghrelin and Adiponectin.
| Study group | Role | What they receive |
|---|---|---|
| Triticum aestivum | Active comparator | A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg of triticum aestivum orally every 12 hours for 120 days. Receives: Drug: Triticum Aestivum |
| Placebo (calcined magnesia) | Placebo comparator | A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg of calcined magnesia orally every 12 hours for 120 days. Receives: Drug: Placebo (calcined magnesia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of Triticum aestivum on leptin in patients with obesity.
To quantify the serum concentrations of leptin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo.
Measured: 120 days
To evaluate the effect of Triticum aestivum on ghrelin in patients with obesity.
To quantify the serum concentrations of ghrelin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo.
Measured: 120 days
To evaluate the effect of Triticum aestivum on adiponectin in patients with obesity.
To quantify the serum concentrations of adiponectin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo.
Measured: 120 days
To evaluate the effect of Triticum aestivum on satiety regulation
To evaluate the effect on satiety by the visual analog scale for satiety and appetite
Measured: 120 days
To evaluate the effect of Triticum aestivum on appetite regulation
To evaluate the effect on satiety by the visual analog scale for satiety and appetite
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start3 Jan 2024
- Primary completion27 Nov 2024 (estimated)
- Study completion24 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled clinical trial, of two parallel groups, double blind, with random assignment and control group. 38 patients: 1. 19 patients with 500 mg of triticum aestivum orally every 12 hours for 120 days. 2. 19 patients with 500 mg of placebo orally every 12 hours for 120 days. * Visit 1/ Day -7: Screening period, information about the study, signing of informed consent, medical history, anthropometric measurements, baseline laboratory tests. * Visit 2/Day 0: Randomization, 60 tablets of Triticum aestivum or placebo will be given, general diet and exercise recommendations. * Visit 3,4,5/Day 30,60,90: Treatment adherence evaluation, laboratory tests, adverse events evaluation, general diet and exercise recommendations and 60 tablets of Triticum aestivum or placebo will be given. * Visit 6/Final/Day 120 ÷ 7: Anthropometric measurements will be taken, laboratory tests will be performed, adherence to treatment and adverse events will be
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sandra O Hernandez Gonzalez, PhD, Principal investigator, Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496100
- Sponsor's protocol ID
- R-2023-1301-251
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data resulting from the clinical investigation, except the personal identification of the subjects (name, address, telephone, etc.)
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Triticum Aestivum on Appetite Regulation and the Ghrelin, Leptin, Adiponectin Hormonal Axis in Patients With Obesity
- ClinicalTrials.gov ID
- NCT06496100
- Acronym / sponsor ID
- R-2023-1301-251
- Conditions
- Obesity, Leptin Deficiency, Ghrelin, Adiponectin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 27 Nov 2024 (estimated)
- Study completion
- 24 Dec 2024 (estimated)
- First posted
- 11 Jul 2024 (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.
Obesity represents one of the major health problems worldwide; it is clear that current approaches to address obesity are largely unsuccessful. The endocrine axis of leptin and ghrelin acts as the critical link between adipose tissue and hypothalamic centers that regulate food intake, satiety, energy expenditure and weight.
Despite being a highly prevalent disease with major complications, current therapeutic options are not sufficient, as they are not ideal for the entire population. The importance of new pharmacological interventions that can be evaluated in the population at risk as an early form of treatment to avoid the development of chronic diseases with high morbidity and mortality.
Natural products such as Triticum aestivum and their high content of bioactive principles have been described for their pharmacokinetic functions in weight reduction, insulin resistance and modulation of neuropeptides involved in food intake.
Detailed description
A double-blind clinical trial is proposed, with two parallel groups, with random assignment and group control. The universe of the sample will be patients with a diagnosis of obesity, residents of the Guadalajara Metropolitan Area, who agree to participate by signing informed consent and can go to the Biomedical Unit 02 of the Mexican Institute of Social Security.
Two parallel groups, with randomization by software using envelopes, will require a total of 38 patients, which will be distributed as follows: 1) A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg capsules with lyophilized Triticum aestivum orally every 12 hours for 120 days, and 2) A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg capsules of placebo (calcined magnesia) orally every 12 hours for 120 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Controlled clinical trial, of two parallel groups, double blind, with random assignment and control group. 38 patients: 1. 19 patients with 500 mg of triticum aestivum orally every 12 hours for 120 days. 2. 19 patients with 500 mg of placebo orally every 12 hours for 120 days. * Visit 1/ Day -7: Screening period, information about the study, signing of informed consent, medical history, anthropometric measurements, baseline laboratory tests. * Visit 2/Day 0: Randomization, 60 tablets of Triticum aestivum or placebo will be given, general diet and exercise recommendations. * Visit 3,4,5/Day 30,60,90: Treatment adherence evaluation, laboratory tests, adverse events evaluation, general diet and exercise recommendations and 60 tablets of Triticum aestivum or placebo will be given. * Visit 6/Final/Day 120 ÷ 7: Anthropometric measurements will be taken, laboratory tests will be performed, adherence to treatment and adverse events will be
| Arm | Type | Receives |
|---|---|---|
| Triticum aestivum | Active comparator | Drug: Triticum AestivumA group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg of triticum aestivum orally every 12 hours for 120 days. |
| Placebo (calcined magnesia) | Placebo comparator | Drug: Placebo (calcined magnesia)A group of 19 patients with a diagnosis of obesity without pharmacological or surgical treatment, who will receive 500 mg of calcined magnesia orally every 12 hours for 120 days. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- People of any sex (eumenorrheic women with mechanical or definitive contraceptive method without hormonal treatment).
- Age from 30 to 50 years old. Residents of the metropolitan area of Guadalajara. Signed informed consent form. People with a diagnosis of obesity (BMI ≥30 - 39.9 kg/m2), stable body weight within the 3 months prior to the start of the study.
Key exclusion criteria (7 listed)
- Diagnosis of diabetes and dyslipidemia. Diagnosis of anxiety and/or depression. History of: liver disease, chronic kidney disease, thyroid disease, cancer. Antidiabetic treatment, lipid-lowering, food supplements, antidepressants, corticosteroids.
- Acute infectious processes Alcoholism and/or active smoking in any intensity within the 12 months prior to the start of the study.
- Suspected or confirmed pregnancy or breastfeeding. History of drug intake. Recent surgery (<3 months) Carrying a pacemaker, or any other bioelectronic or metallic element. Excessive sedentary lifestyle defined as physical activity less than the equivalent of 15 minutes of walking per day.
- Excessive exercise, defined as physical activity equivalent to running for 60 minutes per day.
- Intake of anorexigenic drugs, hypolipidemic drugs or drugs with effect on body weight.
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 |
|---|---|---|
| Triticum AestivumThe intervention period will be 120 days, looking for effects on appetite regulation and the hormonal axis Leptin, Ghrelin and Adiponectin. | Drug | Triticum aestivum |
| Placebo (calcined magnesia)Also: Calcined magnesiaThe intervention period will be 120 days, looking for effects on appetite regulation and the hormonal axis Leptin, Ghrelin and Adiponectin. | Drug | Placebo (calcined magnesia) |
Primary outcome
To evaluate the effect of Triticum aestivum on leptin in patients with obesity.
Time frame: 120 days
To quantify the serum concentrations of leptin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo.
To evaluate the effect of Triticum aestivum on ghrelin in patients with obesity.
Time frame: 120 days
To quantify the serum concentrations of ghrelin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo.
To evaluate the effect of Triticum aestivum on adiponectin in patients with obesity.
Time frame: 120 days
To quantify the serum concentrations of adiponectin ( pg/mL) before and after of treatment with 1000 mg of Triticum aestivum or placebo.
To evaluate the effect of Triticum aestivum on satiety regulation
Time frame: 120 days
To evaluate the effect on satiety by the visual analog scale for satiety and appetite
To evaluate the effect of Triticum aestivum on appetite regulation
Time frame: 120 days
To evaluate the effect on satiety by the visual analog scale for satiety and appetite
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Hypothalamic IKKβ/NF-κB and ER Stress Link Overnutrition to Energy Imbalance and Obesity.Link provided by the sponsor.
- Issues in Measuring and Interpreting Human Appetite (Satiety/Satiation) and Its Contribution to Obesity.Link provided by the sponsor.
- Eating and Weight Disorders - Studies on Anorexia, Bulimia and ObesityLink provided by the sponsor.
- Proanthocyanidins potentiate hypothalamic leptin/STAT3 signalling and Pomc gene expression in rats with diet-induced obesity.Link provided by the sponsor.
- Hunger and Satiety Mechanisms and Their Potential Exploitation in the Regulation of Food Intake.Link provided by the sponsor.
- STAT3 signalling is required for leptin regulation of energy balance but not reproduction.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All data resulting from the clinical investigation, except the personal identification of the subjects (name, address, telephone, etc.)
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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.
Sandra O Hernandez Gonzalez, PhD principal investigator
Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triticum Aestivum in people with Obesity and Leptin Deficiency, run by Coordinación de Investigación en 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 2 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: status not confirmed, as of the sponsor's last update on 11 Jul 2024. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra O Hernandez Gonzalez, PhD (523336170060 ext. 31494, drasandy2003@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of Triticum aestivum on leptin in patients with obesity. (time frame: 120 days). The study lists 5 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 11 Jul 2024.