ObesityPhase 3NCT06950138
Efficacy of Triticum Aestivum Over Vascular Function in Mexican Obese Patients
A Phase 3 study testing Triticum aestivum and calcined magnesia in people with Obesity and Vascular Risk, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
This study aims to evaluate the efficacy of Triticum aestivum as a treatment for improving the vascular function in Mexican obese patients. We conducted a triple-blind, randomized, placebo controlled clinical trial, involving obese individuals from the metropolitan area of Guadalajara. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Obesity, Vascular Risk
- What is being tested?
- Triticum aestivum and calcined magnesia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 3 Jan 2023to 5 Feb 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sex indistinct, age between 30 and 60 years, BMI ≥30 and <40 kg/m2, signed informed consent, eumenorrheic women with mechanical or definitive contraceptive method without hormonal treatment.
Who cannot join
- History of: liver disease, chronic kidney disease, thyroid disease, cancer, diagnosis of diabetes, hypertension, dyslipidemia, patients with antihypertensive and antidiabetic treatment, lipid-lowering drugs, dietary supplements, acute infectious processes, alcoholism and/or active smoking, current pregnancy or breastfeeding, history of drug intake, recent surgery (in the last 3 months), pacemaker implantation, or any other permanent bioelectronic or metallic element that may modify the bioimpedance reading or may be affected by it.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Speciality, West National Medical Center, Mexican Social Security Institute.
Guadalajara, Jalisco, 44380
About this study
This study aims to evaluate the efficacy of Triticum aestivum as a treatment for improving the vascular function in Mexican obese patients. We conducted a triple-blind, randomized, placebo controlled clinical trial, involving obese individuals from the metropolitan area of Guadalajara. The participants were randomly assigned to either Triticum aestivum (intervention group) or placebo supplementation (control). The primary outcome measures were those related with the vascular function using non-invasive methods such as flow-mediated dilation and wave pulse velocity measurements. Secondary outcomes included changes in anthropometric or clinical measures, laboratory results and molecular markers (endothelin-1 and nitric oxide). Data were collected at baseline and after the intervention period. Statistical analyses were performed to determine the significance of the observed changes.
Read the detailed description
Background:
Obesity is a multifactorial disease highly prevalent among Mexican population. It is closely related to the maintenance of a pro-inflammatory syndrome. This promotes the development of physiopathological mechanisms that support and perpetuate the vascular disfunction which can contribute to the development of cardiovascular disease.
The vascular disfunction is closely related to the impaired endothelial function and increase arterial stiffness. Currently there is no specific treatment for vascular disfunction. Triticum aestivum, or wheatgrass, is a known plant, used primary for its anti-inflammatory and antioxidant properties. This trial aim to investigate the potential health benefits in vascular function of Mexican obese patients. Triticum aestivum is rich in fibers, vitamins, minerals, and polyphenols. Polyphenols, such as flavonoids have antioxidant and anti-inflammatory properties. The flavonoids in wheat grass can scavenge free radicals, preventing cellular damage and preserving endothelial function. In addition, flavonoids have demonstrated anti-inflammatory effects, modulating inflammatory processes within the vascular system. Moreover, the flavonoids can contribute to a improve lipid profile by reducing low density cholesterol levels.
Objetive:
Evaluate the efficacy of Triticum aestivum versus placebo over the vascular function of Mexican obese patients.
Study Design:
A randomized, triple-blind, placebo-controlled clinical trial in Mexican patients with obesity from the metropolitan area of Guadalajara diagnosed according to WHO criteria, who agreed to participate in the protocol through informed consent, randomly assigned to two groups: an intervention group that will receive 1 capsule of 500 mg of Triticum aestivum every 12 hours for 120 days (n=10), and a control group that will receive placebo with the same organoleptic characteristics for the same period of time (n=10).
Participants:
20 Mexican patients with obesity from the metropolitan area of Guadalajara diagnosed according to WHO criteria (BMI between ≥30 and <40 kg/m2), both sexes, who agreed to participate in the protocol through informed consent, with no known co-mobilities, use of current medication or any contraindication.
Intervention:
Intervention group that received 1 capsule of 500 mg of Triticum aestivum every 12 hours for 120 days (n=10), and a control group that received placebo with the same organoleptic characteristics for the same period (n=10). Both groups received general lifestyle and dietary recommendations.
Outcome Measures:
Primary outcome measures included flow-mediated dilation and arterial stiffness assessed by wave pulse velocity using non-invasive techniques. Secondary outcome measures encompassed anthropometric and clinical parameters, as well as laboratory results, and molecular markers such as endothelin-1 and nitric oxide.
Data Collection:
Baseline and post-intervention data were collected through standardized assessments and laboratory tests.
- Conditions
- Obesity, Vascular Risk
- Being tested
- Triticum aestivum, calcined magnesia
- Keywords
- Triticum aestivum, Obesity, Arterial stiffness, Flow-mediated dilatation, Wave pulse velocity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triticum aestivumDrug
During the intervention period, the aim is to evaluate changes in the patient's vascular function.
calcined magnesiaDrug
Also called Magnesium oxide
During the intervention period, the aim is to evaluate changes in the patient's vascular function.
| Study group | Role | What they receive |
|---|---|---|
| Triticum aestivum | Active comparator | A group of 20 patients with a diagnosis of obesity without current treatment or other associated pathologies, who will receive 500 mg of triticum aestivum orally every 12 hours for 120 days. |
| Calcined magnesia | Placebo comparator | A group of 20 patients with a diagnosis of obesity without current treatment or other associated pathologies, who will recive 500 mg of calcined magnesia oraly every 12 hours for 120 days. Receives: Drug: calcined magnesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wave Pulse Velocity
The transit time of an aortic pressure wave between the common carotid artery and the common femoral artery. It is a standard measure of arterial stiffness.
Measured: 12 weeks
Flow-mediated dilatation
Ecosonographic assessment of diameter changes in of the brachial artery secondary to increased blood flow.
Measured: 12 weeks
Secondary outcomes (5)
Body Max Index
An indicator of body density as determined by the relationship of body weight to body height. BMI=weight (kg)/height squared (m2). BMI correlates with body fat (adipose tissue). Their relationship varies with age and gender. For adults, BMI falls into these categories: below 18.5 (underweight); 18.5-24.9 (normal); 25.0-29.9 (overweight); 30.0 and above (obese).
Measured: 12 weeks
Blood Pressure
The blood pressure in the arteries. It is commonly measured with a sphygmomanometer on the upper arm which represents the arterial pressure in the brachial artery.
Measured: 12 weeks
Waist Hip Ratio
The waist circumference measurement divided by the hip circumference measurement. For both men and women, a waist-to-hip ratio (WHR) of 1.0 or higher is considered "at risk" for undesirable health consequences, such as heart disease and ailments associated with overweight. A healthy WHR is 0.90 or less for men, and 0.80 or less for women.
Measured: 12 weeks
Medication Adherence
Voluntary cooperation of the patient in taking drugs or medicine as prescribed. This includes timing, dosage, and frequency.
Measured: 12 weeks
Atherogenic Index
Logarithmically transformed ratio of molar concentrations of triglycerides to HDL-cholesterol
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start3 Jan 2023
- Primary completion5 Jan 2025
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- 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
- Intervention group that received 1 capsule of 500 mg of Triticum aestivum every 12 hours for 120 days (n=10), and a control group that received placebo with the same organoleptic characteristics for the same period (n=10). Both groups received general lifestyle and dietary recommendations.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sandra O Hernández González, PhD, Principal investigator, Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950138
- Sponsor's protocol ID
- R-2023-130-177
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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, teelephone, etc.)
Publications
Kopustinskiene DM, Jakstas V, Savickas A, Bernatoniene J. Flavonoids as Anticancer Agents. Nutrients. 2020 Feb 12;12(2):457. doi: 10.3390/nu12020457.
PubMed 32059369Hostetler GL, Ralston RA, Schwartz SJ. Flavones: Food Sources, Bioavailability, Metabolism, and Bioactivity. Adv Nutr. 2017 May 15;8(3):423-435. doi: 10.3945/an.116.012948. Print 2017 May.
PubMed 28507008Bitew M, Desalegn T, Demissie TB, Belayneh A, Endale M, Eswaramoorthy R. Pharmacokinetics and drug-likeness of antidiabetic flavonoids: Molecular docking and DFT study. PLoS One. 2021 Dec 10;16(12):e0260853. doi: 10.1371/journal.pone.0260853. eCollection 2021.
PubMed 34890431Ciumarnean L, Milaciu MV, Runcan O, Vesa SC, Rachisan AL, Negrean V, Perne MG, Donca VI, Alexescu TG, Para I, Dogaru G. The Effects of Flavonoids in Cardiovascular Diseases. Molecules. 2020 Sep 21;25(18):4320. doi: 10.3390/molecules25184320.
PubMed 32967119Yamagata K, Yamori Y. Inhibition of Endothelial Dysfunction by Dietary Flavonoids and Preventive Effects Against Cardiovascular Disease. J Cardiovasc Pharmacol. 2020 Jan;75(1):1-9. doi: 10.1097/FJC.0000000000000757.
PubMed 31613843Rees A, Dodd GF, Spencer JPE. The Effects of Flavonoids on Cardiovascular Health: A Review of Human Intervention Trials and Implications for Cerebrovascular Function. Nutrients. 2018 Dec 1;10(12):1852. doi: 10.3390/nu10121852.
PubMed 30513729Micek A, Godos J, Del Rio D, Galvano F, Grosso G. Dietary Flavonoids and Cardiovascular Disease: A Comprehensive Dose-Response Meta-Analysis. Mol Nutr Food Res. 2021 Mar;65(6):e2001019. doi: 10.1002/mnfr.202001019. Epub 2021 Feb 25.
PubMed 33559970Yahfoufi N, Alsadi N, Jambi M, Matar C. The Immunomodulatory and Anti-Inflammatory Role of Polyphenols. Nutrients. 2018 Nov 2;10(11):1618. doi: 10.3390/nu10111618.
PubMed 30400131Luyen BT, Thao NP, Tai BH, Lim JY, Ki HH, Kim DK, Lee YM, Kim YH. Chemical constituents of Triticum aestivum and their effects on adipogenic differentiation of 3T3-L1 preadipocytes. Arch Pharm Res. 2015 Jun;38(6):1011-8. doi: 10.1007/s12272-014-0478-2. Epub 2014 Sep 23.
PubMed 25241774Poudel B, Nepali S, Xin M, Ki HH, Kim YH, Kim DK, Lee YM. Flavonoids from Triticum aestivum inhibit adipogenesis in 3T3-L1 cells by upregulating the insig pathway. Mol Med Rep. 2015 Aug;12(2):3139-45. doi: 10.3892/mmr.2015.3700. Epub 2015 Apr 29.
PubMed 25936595Im JY, Ki HH, Xin M, Kwon SU, Kim YH, Kim DK, Hong SP, Jin JS, Lee YM. Anti-obesity effect of Triticum aestivum sprout extract in high-fat-diet-induced obese mice. Biosci Biotechnol Biochem. 2015;79(7):1133-40. doi: 10.1080/09168451.2015.1006567. Epub 2015 Apr 30.
PubMed 25925980Bueno PCDS, Barbalho SM, Guiguer EL, Souza MDSS, Medeiros IRA, Zattiti IV, Bueno MDS, Nutels GS, Goulart RA, Araujo AC. Effects of Green Wheat (Triticum turgidum) and Common Wheat (Triticum aestivum) on the Metabolic Profile of Wistar Rats. J Med Food. 2019 Dec;22(12):1222-1225. doi: 10.1089/jmf.2019.0089. Epub 2019 Jul 18.
PubMed 31329009Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981 Aug;30(2):239-45. doi: 10.1038/clpt.1981.154. No abstract available.
PubMed 7249508Townsend RR. Arterial Stiffness: Recommendations and Standardization. Pulse (Basel). 2017 Jan;4(Suppl 1):3-7. doi: 10.1159/000448454. Epub 2016 Dec 23.
PubMed 28275588Daiber A, Steven S, Weber A, Shuvaev VV, Muzykantov VR, Laher I, Li H, Lamas S, Munzel T. Targeting vascular (endothelial) dysfunction. Br J Pharmacol. 2017 Jun;174(12):1591-1619. doi: 10.1111/bph.13517. Epub 2016 Jul 4.
PubMed 27187006
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Triticum Aestivum Over Vascular Function in Mexican Obese Patients
- ClinicalTrials.gov ID
- NCT06950138
- Acronym / sponsor ID
- R-2023-130-177
- Conditions
- Obesity, Vascular Risk
- Keywords
- Triticum aestivum, Obesity, Arterial stiffness, Flow-mediated dilatation, Wave pulse velocity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 30 Apr 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.
This study aims to evaluate the efficacy of Triticum aestivum as a treatment for improving the vascular function in Mexican obese patients. We conducted a triple-blind, randomized, placebo controlled clinical trial, involving obese individuals from the metropolitan area of Guadalajara. The participants were randomly assigned to either Triticum aestivum (intervention group) or placebo supplementation (control). The primary outcome measures were those related with the vascular function using non-invasive methods such as flow-mediated dilation and wave pulse velocity measurements. Secondary outcomes included changes in anthropometric or clinical measures, laboratory results and molecular markers (endothelin-1 and nitric oxide). Data were collected at baseline and after the intervention period. Statistical analyses were performed to determine the significance of the observed changes.
Detailed description
Background:
Obesity is a multifactorial disease highly prevalent among Mexican population. It is closely related to the maintenance of a pro-inflammatory syndrome. This promotes the development of physiopathological mechanisms that support and perpetuate the vascular disfunction which can contribute to the development of cardiovascular disease.
The vascular disfunction is closely related to the impaired endothelial function and increase arterial stiffness. Currently there is no specific treatment for vascular disfunction. Triticum aestivum, or wheatgrass, is a known plant, used primary for its anti-inflammatory and antioxidant properties. This trial aim to investigate the potential health benefits in vascular function of Mexican obese patients. Triticum aestivum is rich in fibers, vitamins, minerals, and polyphenols. Polyphenols, such as flavonoids have antioxidant and anti-inflammatory properties. The flavonoids in wheat grass can scavenge free radicals, preventing cellular damage and preserving endothelial function. In addition, flavonoids have demonstrated anti-inflammatory effects, modulating inflammatory processes within the vascular system. Moreover, the flavonoids can contribute to a improve lipid profile by reducing low density cholesterol levels.
Objetive:
Evaluate the efficacy of Triticum aestivum versus placebo over the vascular function of Mexican obese patients.
Study Design:
A randomized, triple-blind, placebo-controlled clinical trial in Mexican patients with obesity from the metropolitan area of Guadalajara diagnosed according to WHO criteria, who agreed to participate in the protocol through informed consent, randomly assigned to two groups: an intervention group that will receive 1 capsule of 500 mg of Triticum aestivum every 12 hours for 120 days (n=10), and a control group that will receive placebo with the same organoleptic characteristics for the same period of time (n=10).
Participants:
20 Mexican patients with obesity from the metropolitan area of Guadalajara diagnosed according to WHO criteria (BMI between ≥30 and <40 kg/m2), both sexes, who agreed to participate in the protocol through informed consent, with no known co-mobilities, use of current medication or any contraindication.
Intervention:
Intervention group that received 1 capsule of 500 mg of Triticum aestivum every 12 hours for 120 days (n=10), and a control group that received placebo with the same organoleptic characteristics for the same period (n=10). Both groups received general lifestyle and dietary recommendations.
Outcome Measures:
Primary outcome measures included flow-mediated dilation and arterial stiffness assessed by wave pulse velocity using non-invasive techniques. Secondary outcome measures encompassed anthropometric and clinical parameters, as well as laboratory results, and molecular markers such as endothelin-1 and nitric oxide.
Data Collection:
Baseline and post-intervention data were collected through standardized assessments and laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group that received 1 capsule of 500 mg of Triticum aestivum every 12 hours for 120 days (n=10), and a control group that received placebo with the same organoleptic characteristics for the same period (n=10). Both groups received general lifestyle and dietary recommendations.
| Arm | Type | Receives |
|---|---|---|
| Triticum aestivum | Active comparator | –A group of 20 patients with a diagnosis of obesity without current treatment or other associated pathologies, who will receive 500 mg of triticum aestivum orally every 12 hours for 120 days. |
| Calcined magnesia | Placebo comparator | Drug: calcined magnesiaA group of 20 patients with a diagnosis of obesity without current treatment or other associated pathologies, who will recive 500 mg of calcined magnesia oraly every 12 hours for 120 days. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Sex indistinct, age between 30 and 60 years, BMI ≥30 and <40 kg/m2, signed informed consent, eumenorrheic women with mechanical or definitive contraceptive method without hormonal treatment.
Key exclusion criteria (1 listed)
- History of: liver disease, chronic kidney disease, thyroid disease, cancer, diagnosis of diabetes, hypertension, dyslipidemia, patients with antihypertensive and antidiabetic treatment, lipid-lowering drugs, dietary supplements, acute infectious processes, alcoholism and/or active smoking, current pregnancy or breastfeeding, history of drug intake, recent surgery (in the last 3 months), pacemaker implantation, or any other permanent bioelectronic or metallic element that may modify the bioimpedance reading or may be affected by it.
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 aestivumDuring the intervention period, the aim is to evaluate changes in the patient's vascular function. | Drug | – |
| calcined magnesiaAlso: Magnesium oxideDuring the intervention period, the aim is to evaluate changes in the patient's vascular function. | Drug | Calcined magnesia |
Primary outcome
Wave Pulse Velocity
Time frame: 12 weeks
The transit time of an aortic pressure wave between the common carotid artery and the common femoral artery. It is a standard measure of arterial stiffness.
Flow-mediated dilatation
Time frame: 12 weeks
Ecosonographic assessment of diameter changes in of the brachial artery secondary to increased blood flow.
5 secondary outcomes
Body Max Index
Time frame: 12 weeks
Blood Pressure
Time frame: 12 weeks
Waist Hip Ratio
Time frame: 12 weeks
Medication Adherence
Time frame: 12 weeks
Atherogenic Index
Time frame: 12 weeks
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 30 Apr 2025.
- Background: PubMed 32059369Kopustinskiene DM, Jakstas V, Savickas A, Bernatoniene J. Flavonoids as Anticancer Agents. Nutrients. 2020 Feb 12;12(2):457. doi: 10.3390/nu12020457.
- Background: PubMed 28507008Hostetler GL, Ralston RA, Schwartz SJ. Flavones: Food Sources, Bioavailability, Metabolism, and Bioactivity. Adv Nutr. 2017 May 15;8(3):423-435. doi: 10.3945/an.116.012948. Print 2017 May.
- Background: PubMed 34890431Bitew M, Desalegn T, Demissie TB, Belayneh A, Endale M, Eswaramoorthy R. Pharmacokinetics and drug-likeness of antidiabetic flavonoids: Molecular docking and DFT study. PLoS One. 2021 Dec 10;16(12):e0260853. doi: 10.1371/journal.pone.0260853. eCollection 2021.
- Background: PubMed 32967119Ciumarnean L, Milaciu MV, Runcan O, Vesa SC, Rachisan AL, Negrean V, Perne MG, Donca VI, Alexescu TG, Para I, Dogaru G. The Effects of Flavonoids in Cardiovascular Diseases. Molecules. 2020 Sep 21;25(18):4320. doi: 10.3390/molecules25184320.
- Background: PubMed 31613843Yamagata K, Yamori Y. Inhibition of Endothelial Dysfunction by Dietary Flavonoids and Preventive Effects Against Cardiovascular Disease. J Cardiovasc Pharmacol. 2020 Jan;75(1):1-9. doi: 10.1097/FJC.0000000000000757.
- Background: PubMed 30513729Rees A, Dodd GF, Spencer JPE. The Effects of Flavonoids on Cardiovascular Health: A Review of Human Intervention Trials and Implications for Cerebrovascular Function. Nutrients. 2018 Dec 1;10(12):1852. doi: 10.3390/nu10121852.
- Background: PubMed 33559970Micek A, Godos J, Del Rio D, Galvano F, Grosso G. Dietary Flavonoids and Cardiovascular Disease: A Comprehensive Dose-Response Meta-Analysis. Mol Nutr Food Res. 2021 Mar;65(6):e2001019. doi: 10.1002/mnfr.202001019. Epub 2021 Feb 25.
- Background: PubMed 30400131Yahfoufi N, Alsadi N, Jambi M, Matar C. The Immunomodulatory and Anti-Inflammatory Role of Polyphenols. Nutrients. 2018 Nov 2;10(11):1618. doi: 10.3390/nu10111618.
- Background: PubMed 25241774Luyen BT, Thao NP, Tai BH, Lim JY, Ki HH, Kim DK, Lee YM, Kim YH. Chemical constituents of Triticum aestivum and their effects on adipogenic differentiation of 3T3-L1 preadipocytes. Arch Pharm Res. 2015 Jun;38(6):1011-8. doi: 10.1007/s12272-014-0478-2. Epub 2014 Sep 23.
- Background: PubMed 25936595Poudel B, Nepali S, Xin M, Ki HH, Kim YH, Kim DK, Lee YM. Flavonoids from Triticum aestivum inhibit adipogenesis in 3T3-L1 cells by upregulating the insig pathway. Mol Med Rep. 2015 Aug;12(2):3139-45. doi: 10.3892/mmr.2015.3700. Epub 2015 Apr 29.
- Background: PubMed 25925980Im JY, Ki HH, Xin M, Kwon SU, Kim YH, Kim DK, Hong SP, Jin JS, Lee YM. Anti-obesity effect of Triticum aestivum sprout extract in high-fat-diet-induced obese mice. Biosci Biotechnol Biochem. 2015;79(7):1133-40. doi: 10.1080/09168451.2015.1006567. Epub 2015 Apr 30.
- Background: PubMed 31329009Bueno PCDS, Barbalho SM, Guiguer EL, Souza MDSS, Medeiros IRA, Zattiti IV, Bueno MDS, Nutels GS, Goulart RA, Araujo AC. Effects of Green Wheat (Triticum turgidum) and Common Wheat (Triticum aestivum) on the Metabolic Profile of Wistar Rats. J Med Food. 2019 Dec;22(12):1222-1225. doi: 10.1089/jmf.2019.0089. Epub 2019 Jul 18.
- Cardiovascular DiseasesLink provided by the sponsor.
- What Is Cardiovascular Disease.Link provided by the sponsor.
- Atención oportuna, fundamental para prevenir y atender enfermedades cardiovasculares.Link provided by the sponsor.
- Obesity and Overweight.Link provided by the sponsor.
- Programa de Acción Específico Prevención y Control de la Obesidad y Riesgo Cardiovascular 2013-2018Link provided by the sponsor.
- Sobrepeso y Obesidad: factores de riesgo para desarrollar diabetes. México.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, teelephone, 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 Hernández González, 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 and calcined magnesia in people with Obesity and Vascular Risk, 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 1 inclusion and 1 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 30 Apr 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. 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?
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?
Wave Pulse Velocity (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06950138, which also lists 25 linked publications.
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 30 Apr 2025.