ObesityPhase 3NCT06501248
Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity
A Phase 3 study testing Triticum Aestivum in people with Obesity and Drug Effect, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
Obesity is a metabolic disease which has been declared as the most prevalent chronic health problem in adults; according to the World Health Organization (WHO), it is defined as an increase in Body Mass Index (BMI) greater than or equal to 30 kg/m2. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Drug Effect, Insulin Sensitivity
- 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
- 36 participants
- Where
- 1 siteMexico
- Study dates
- 14 Jul 2022to 10 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
- Ability to communicate and meet all study requirements.
- People who sign the consent under written information prior to carrying out any procedure
- People of any sex, (eumenorrheic women with mechanical or definitive contraceptive method without hormonal treatment) Mexicans from 30 to 50 years of age, residents of Guadalajara, Jalisco, beneficiaries of the Instituto Mexicano del Seguro Social (IMSS)
- 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, defined as a variability in body weight of less than 5%.
- Fasting glucose <126 mg/dl
- Cholesterol <240 mg/dl
- Triglycerides <300 mg/dl
- Resting systolic blood pressure less than 140 mmHg with resting diastolic blood pressure less than 90 mmHg
Who cannot join
- Suspected or confirmed pregnancy.
- Women breastfeeding or in the postpartum or postpartum period.
- History of smoking at any intensity within the 12 months prior to the start of the study.
- 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 a day.
- Intake of drugs that are anorexigenic, lipid-lowering or have an effect on body weight.
Show all 11Show fewer
- History of any type of cancer, hyperthyroidism, hypothyroidism, kidney disease, liver disease, and pancreatic disease.
- History of hypersensitivity to the study drug (gluten)
- History of drug intake
- Carrying of a pacemaker, or any other permanent bioelectronic element that can modify the electrical bioimpedance reading or can be affected by it.
- Patients diagnosed with Morbid Obesity (BMI ≥ 40 kg/m2)
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
Emmanuel A Flores Hernández, MD, 52 3331574157, emmanuel_alex_598@hotmail.com
About this study
Obesity is a metabolic disease which has been declared as the most prevalent chronic health problem in adults; according to the World Health Organization (WHO), it is defined as an increase in Body Mass Index (BMI) greater than or equal to 30 kg/m2.
In Mexico, according to data from the National Health and Nutrition Survey (ENSANUT) 2018-2019, the prevalence of overweight in adults is 39.1% (36.6% in women, 42.5% in men), of obesity is 36.1% (40.2% in women, 30.5% in men) and of abdominal adiposity 81.6% (88.4% in women and 72.1% in men), with a higher proportion found in the north of the country.
Read more
In 2010, it was estimated that obesity was the main cause of 3.4 million deaths, the main complications being cardiovascular disease, diabetes mellitus and various types of cancer.
The complications of obesity are very varied, mainly presenting changes in the metabolic profile, such as increased blood pressure and abdominal circumference, hypertriglyceridemia and hypercholesterolemia. Another of the main complications derived from obesity is insulin resistance, which is defined as a decreased biological response of peripheral tissues to a specific concentration of insulin with consequent compensatory hyperinsulinemia.
The treatment of obesity is based on lifestyle changes (diet and exercise), in addition, there are pharmacological and surgical treatments, however, they are not applicable to the entire population, so despite being a highly prevalent disease with major complications, current therapeutic options are insufficient.
Triticum aestivum, better known as wheat grass, is a very common fiber in the diet of the world population, including the Mexican population, in which multiple pre-clinical studies have been reported where the effect of triticum aestivum on the decrease of components of the metabolic profile, such as glycemia, cholesterol, triglycerides and weight, as well as an improvement in insulin sensitivity, has been evidenced; To date, no serious adverse effects related to its consumption have been described, and it can be considered as an effective therapeutic alternative for patients with obesity.
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. A total of 36 patients will be followed, which will be distributed as follows: 1) A group of 18 patients with a diagnosis of obesity without pharmacological or emergency treatment, who will receive 500 mg of triticum aestivum orally every 12 hours for 120 days, and 2) A group of 18 patients diagnosed with obesity without pharmacological or surgical treatment, who will receive 500 mg of placebo (calcined magnesia) orally every 12 days for 120 days.
- Conditions
- Obesity, Drug Effect, Insulin Sensitivity
- Being tested
- Triticum Aestivum, Placebo (calcined magnesia)
- Medical subject headings
- Obesity, Insulin Resistance
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, searching for effects on insulin sensitivity and metabolic control.
Placebo (calcined magnesia)Drug
Also called Calcined magnesia
The intervention period will be 120 days, searching for effects on insulin sensitivity and metabolic control.
| Study group | Role | What they receive |
|---|---|---|
| Triticum aestivum | Active comparator | A group of 18 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 18 patients diagnosed with obesity without pharmacological or surgical treatment, who will receive 500 mg of placebo (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.
The effect of Triticum aestivum on glucose in patients with obesity
Changes in levels of glucose in mg/dl.
Measured: 120 days
The effect of Triticum aestivum on insulin sensitivity in patients with obesity
Changes in levels of insulin sensitivity in the triglyceride and glucose index (natural logarithm ((glucose in mg/dl * triglycerides in mg/dl)/2))
Measured: 120 days
The effect of Triticum aestivum on high-density lipoprotein cholesterol in patients with obesity
Changes in levels of high-density lipoprotein in mg/dl.
Measured: 120 days
The effect of Triticum aestivum on low-density lipoprotein cholesterol in patients with obesity
Changes in levels of low-density lipoprotein cholesterol in mg/dl.
Measured: 120 days
The effect of Triticum aestivum on very low-density lipoprotein cholesterol in patients with obesity
Changes in levels of very low-density lipoprotein cholesterol in mg/dl.
Measured: 120 days
The effect of Triticum aestivum on total cholesterol in patients with obesity
Changes in levels of total cholesterol in mg/dl.
Measured: 120 days
The effect of Triticum aestivum on triglycerides in patients with obesity
Changes in levels of triglycerides in mg/dl.
Measured: 120 days
The effect of Triticum aestivum on body weight in patients with obesity
Changes in levels of body weight in kilograms.
Measured: 120 days
The effect of Triticum aestivum on Body Mass Index in patients with obesity
Changes in levels of Body Mass Index (weight in kilograms / (height in meters squared))
Measured: 120 days
The effect of Triticum aestivum on fat percentage in patients with obesity
Changes in levels of fat percentage (percentage)
Measured: 120 days
The effect of Triticum aestivum on Waist Hip Index in patients with obesity
Changes in levels of Waist Hip Index (waist in centimeters / hip in centimeters)
Measured: 120 days
Secondary outcomes (3)
The effect of Triticum aestivum on blood pressure in patients with obesity
Changes in levels of blood pressure in mmHg.
Measured: 120 days
The effect of Triticum aestivum on renal profile in patients with obesity
Changes in levels of creatinine in mg/dl.
Measured: 120 days
The effect of Triticum aestivum on hepatic profile in patients with obesity
Changes in levels of Alanine aminotransferase in mg/dl and Aspartate aminotransferase in mg/dl
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 posted15 Jul 2024
- Study start14 Jul 2022
- Primary completion30 Aug 2024 (estimated)
- Study completion10 Dec 2024 (estimated)
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
- Controlled clinical trial, of two parallel groups, double blind, with random assignment and control group. 36 patients: 1. 18 patients with 500 mg of triticum aestivum orally every 12 hours for 120 days. 2. 18 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 evaluated.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
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
- NCT06501248
- Sponsor's protocol ID
- R-2022-1301-178
- Status last verified
- Aug 2023
- First submitted
- 26 Mar 2024
- Last updated
- 15 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.)
Publications
Kim SY. The Definition of Obesity. Korean J Fam Med. 2016 Nov;37(6):309. doi: 10.4082/kjfm.2016.37.6.309. Epub 2016 Nov 18. No abstract available.
PubMed 27900066Aktar N, Qureshi NK, Ferdous HS. Obesity: A Review of Pathogenesis and Management Strategies in Adult. Delta Medical College Journal. 2017 Feb 4; 5(1):35-48.
Barquera S, Hernandez-Barrera L, Trejo-Valdivia B, Shamah T, Campos-Nonato I, Rivera-Dommarco J. [Obesity in Mexico, prevalence andtrends in adults. Ensanut 2018-19.]. Salud Publica Mex. 2020 Nov-Dec;62(6):682-692. doi: 10.21149/11630. Spanish.
PubMed 33620965Moreno-Altamirano L, García-García JJ, Soto-Estrada G, Capraro S, Limón-Cruz D. Epidemiología y determinantes sociales asociados a la obesidad y la diabetes tipo 2 en México. Revista Médica Del Hospital General De México. 2014 Jul; 77(3):114-23.
Bihan H, Choleau C, Cohen R, Reach G. [Obesity, immune resistance and metabolic complications: what morbid obesity can teach the doctor]. Presse Med. 2007 Dec;36(12 Pt 3):1893-7. doi: 10.1016/j.lpm.2007.04.001. Epub 2007 Apr 24. French.
PubMed 17459653Ahmed B, Sultana R, Greene MW. Adipose tissue and insulin resistance in obese. Biomed Pharmacother. 2021 May;137:111315. doi: 10.1016/j.biopha.2021.111315. Epub 2021 Feb 6.
PubMed 33561645Roberts CK, Hevener AL, Barnard RJ. Metabolic syndrome and insulin resistance: underlying causes and modification by exercise training. Compr Physiol. 2013 Jan;3(1):1-58. doi: 10.1002/cphy.c110062.
PubMed 23720280D'Adamo E, Caprio S. Type 2 diabetes in youth: epidemiology and pathophysiology. Diabetes Care. 2011 May;34 Suppl 2(Suppl 2):S161-5. doi: 10.2337/dc11-s212. No abstract available.
PubMed 21525449Almeda-Valdes P, Bello-Chavolla OY, Caballeros-Barragan CR, Gomez-Velasco DV, Viveros-Ruiz T, Vargas-Vazquez A, Aguilar-Salinas CA. [Indices para la evaluacion de la resistencia a la insulina en individuos mexicanos sin diabetes]. Gac Med Mex. 2018;154(Supp 2):S50-S55. doi: 10.24875/GMM.18004578. Spanish.
PubMed 30532124Guerrero-Romero F, Simental-Mendia LE, Gonzalez-Ortiz M, Martinez-Abundis E, Ramos-Zavala MG, Hernandez-Gonzalez SO, Jacques-Camarena O, Rodriguez-Moran M. The product of triglycerides and glucose, a simple measure of insulin sensitivity. Comparison with the euglycemic-hyperinsulinemic clamp. J Clin Endocrinol Metab. 2010 Jul;95(7):3347-51. doi: 10.1210/jc.2010-0288. Epub 2010 May 19.
PubMed 20484475Rodrigo-Cano S, Soriano Del Castillo JM, Merino-Torres JF. Causas y tratamiento de la obesidad. Nutricion Clinica y Dietetica Hospitalaria. 2017; 37(4):87-92.
Fonseca-Junior SJ, Sa CG, Rodrigues PA, Oliveira AJ, Fernandes-Filho J. Physical exercise and morbid obesity: a systematic review. Arq Bras Cir Dig. 2013;26 Suppl 1:67-73. doi: 10.1590/s0102-67202013000600015. English, Portuguese.
PubMed 24463903Daneschvar HL, Aronson MD, Smetana GW. FDA-Approved Anti-Obesity Drugs in the United States. Am J Med. 2016 Aug;129(8):879.e1-6. doi: 10.1016/j.amjmed.2016.02.009. Epub 2016 Mar 4.
PubMed 26949003Kushner RF. Weight Loss Strategies for Treatment of Obesity: Lifestyle Management and Pharmacotherapy. Prog Cardiovasc Dis. 2018 Jul-Aug;61(2):246-252. doi: 10.1016/j.pcad.2018.06.001. Epub 2018 Jun 8.
PubMed 29890171Moshawih S, Abdullah Juperi RNA, Paneerselvam GS, Ming LC, Liew KB, Goh BH, Al-Worafi YM, Choo CY, Thuraisingam S, Goh HP, Kifli N. General Health Benefits and Pharmacological Activities of Triticum aestivum L. Molecules. 2022 Mar 17;27(6):1948. doi: 10.3390/molecules27061948.
PubMed 35335312
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity
- ClinicalTrials.gov ID
- NCT06501248
- Acronym / sponsor ID
- R-2022-1301-178
- Conditions
- Obesity, Drug Effect, Insulin Sensitivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 15 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 is a metabolic disease which has been declared as the most prevalent chronic health problem in adults; according to the World Health Organization (WHO), it is defined as an increase in Body Mass Index (BMI) greater than or equal to 30 kg/m2.
In Mexico, according to data from the National Health and Nutrition Survey (ENSANUT) 2018-2019, the prevalence of overweight in adults is 39.1% (36.6% in women, 42.5% in men), of obesity is 36.1% (40.2% in women, 30.5% in men) and of abdominal adiposity 81.6% (88.4% in women and 72.1% in men), with a higher proportion found in the north of the country.
In 2010, it was estimated that obesity was the main cause of 3.4 million deaths, the main complications being cardiovascular disease, diabetes mellitus and various types of cancer.
The complications of obesity are very varied, mainly presenting changes in the metabolic profile, such as increased blood pressure and abdominal circumference, hypertriglyceridemia and hypercholesterolemia. Another of the main complications derived from obesity is insulin resistance, which is defined as a decreased biological response of peripheral tissues to a specific concentration of insulin with consequent compensatory hyperinsulinemia.
The treatment of obesity is based on lifestyle changes (diet and exercise), in addition, there are pharmacological and surgical treatments, however, they are not applicable to the entire population, so despite being a highly prevalent disease with major complications, current therapeutic options are insufficient.
Triticum aestivum, better known as wheat grass, is a very common fiber in the diet of the world population, including the Mexican population, in which multiple pre-clinical studies have been reported where the effect of triticum aestivum on the decrease of components of the metabolic profile, such as glycemia, cholesterol, triglycerides and weight, as well as an improvement in insulin sensitivity, has been evidenced; To date, no serious adverse effects related to its consumption have been described, and it can be considered as an effective therapeutic alternative for patients with obesity.
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. A total of 36 patients will be followed, which will be distributed as follows: 1) A group of 18 patients with a diagnosis of obesity without pharmacological or emergency treatment, who will receive 500 mg of triticum aestivum orally every 12 hours for 120 days, and 2) A group of 18 patients diagnosed with obesity without pharmacological or surgical treatment, who will receive 500 mg of placebo (calcined magnesia) orally every 12 days 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. 36 patients: 1. 18 patients with 500 mg of triticum aestivum orally every 12 hours for 120 days. 2. 18 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 evaluated.
| Arm | Type | Receives |
|---|---|---|
| Triticum aestivum | Active comparator | Drug: Triticum AestivumA group of 18 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 18 patients diagnosed with obesity without pharmacological or surgical treatment, who will receive 500 mg of placebo (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 (8 listed)
- Ability to communicate and meet all study requirements.
- People who sign the consent under written information prior to carrying out any procedure
- People of any sex, (eumenorrheic women with mechanical or definitive contraceptive method without hormonal treatment) Mexicans from 30 to 50 years of age, residents of Guadalajara, Jalisco, beneficiaries of the Instituto Mexicano del Seguro Social (IMSS)
- 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, defined as a variability in body weight of less than 5%.
- Fasting glucose <126 mg/dl
Key exclusion criteria (11 listed)
- Suspected or confirmed pregnancy.
- Women breastfeeding or in the postpartum or postpartum period.
- History of smoking at any intensity within the 12 months prior to the start of the study.
- 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 a day.
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, searching for effects on insulin sensitivity and metabolic control. | Drug | Triticum aestivum |
| Placebo (calcined magnesia)Also: Calcined magnesiaThe intervention period will be 120 days, searching for effects on insulin sensitivity and metabolic control. | Drug | Placebo (calcined magnesia) |
Primary outcome
The effect of Triticum aestivum on glucose in patients with obesity
Time frame: 120 days
Changes in levels of glucose in mg/dl.
The effect of Triticum aestivum on insulin sensitivity in patients with obesity
Time frame: 120 days
Changes in levels of insulin sensitivity in the triglyceride and glucose index (natural logarithm ((glucose in mg/dl * triglycerides in mg/dl)/2))
The effect of Triticum aestivum on high-density lipoprotein cholesterol in patients with obesity
Time frame: 120 days
Changes in levels of high-density lipoprotein in mg/dl.
The effect of Triticum aestivum on low-density lipoprotein cholesterol in patients with obesity
Time frame: 120 days
Changes in levels of low-density lipoprotein cholesterol in mg/dl.
The effect of Triticum aestivum on very low-density lipoprotein cholesterol in patients with obesity
Time frame: 120 days
Changes in levels of very low-density lipoprotein cholesterol in mg/dl.
The effect of Triticum aestivum on total cholesterol in patients with obesity
Time frame: 120 days
Changes in levels of total cholesterol in mg/dl.
The effect of Triticum aestivum on triglycerides in patients with obesity
Time frame: 120 days
Changes in levels of triglycerides in mg/dl.
The effect of Triticum aestivum on body weight in patients with obesity
Time frame: 120 days
Changes in levels of body weight in kilograms.
The effect of Triticum aestivum on Body Mass Index in patients with obesity
Time frame: 120 days
Changes in levels of Body Mass Index (weight in kilograms / (height in meters squared))
The effect of Triticum aestivum on fat percentage in patients with obesity
Time frame: 120 days
Changes in levels of fat percentage (percentage)
The effect of Triticum aestivum on Waist Hip Index in patients with obesity
Time frame: 120 days
Changes in levels of Waist Hip Index (waist in centimeters / hip in centimeters)
3 secondary outcomes
The effect of Triticum aestivum on blood pressure in patients with obesity
Time frame: 120 days
The effect of Triticum aestivum on renal profile in patients with obesity
Time frame: 120 days
The effect of Triticum aestivum on hepatic profile in patients with obesity
Time frame: 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Background: PubMed 27900066Kim SY. The Definition of Obesity. Korean J Fam Med. 2016 Nov;37(6):309. doi: 10.4082/kjfm.2016.37.6.309. Epub 2016 Nov 18. No abstract available.
- BackgroundAktar N, Qureshi NK, Ferdous HS. Obesity: A Review of Pathogenesis and Management Strategies in Adult. Delta Medical College Journal. 2017 Feb 4; 5(1):35-48.
- Background: PubMed 33620965Barquera S, Hernandez-Barrera L, Trejo-Valdivia B, Shamah T, Campos-Nonato I, Rivera-Dommarco J. [Obesity in Mexico, prevalence andtrends in adults. Ensanut 2018-19.]. Salud Publica Mex. 2020 Nov-Dec;62(6):682-692. doi: 10.21149/11630. Spanish.
- BackgroundMoreno-Altamirano L, García-García JJ, Soto-Estrada G, Capraro S, Limón-Cruz D. Epidemiología y determinantes sociales asociados a la obesidad y la diabetes tipo 2 en México. Revista Médica Del Hospital General De México. 2014 Jul; 77(3):114-23.
- Background: PubMed 17459653Bihan H, Choleau C, Cohen R, Reach G. [Obesity, immune resistance and metabolic complications: what morbid obesity can teach the doctor]. Presse Med. 2007 Dec;36(12 Pt 3):1893-7. doi: 10.1016/j.lpm.2007.04.001. Epub 2007 Apr 24. French.
- Background: PubMed 33561645Ahmed B, Sultana R, Greene MW. Adipose tissue and insulin resistance in obese. Biomed Pharmacother. 2021 May;137:111315. doi: 10.1016/j.biopha.2021.111315. Epub 2021 Feb 6.
- Background: PubMed 23720280Roberts CK, Hevener AL, Barnard RJ. Metabolic syndrome and insulin resistance: underlying causes and modification by exercise training. Compr Physiol. 2013 Jan;3(1):1-58. doi: 10.1002/cphy.c110062.
- Background: PubMed 21525449D'Adamo E, Caprio S. Type 2 diabetes in youth: epidemiology and pathophysiology. Diabetes Care. 2011 May;34 Suppl 2(Suppl 2):S161-5. doi: 10.2337/dc11-s212. No abstract available.
- Background: PubMed 30532124Almeda-Valdes P, Bello-Chavolla OY, Caballeros-Barragan CR, Gomez-Velasco DV, Viveros-Ruiz T, Vargas-Vazquez A, Aguilar-Salinas CA. [Indices para la evaluacion de la resistencia a la insulina en individuos mexicanos sin diabetes]. Gac Med Mex. 2018;154(Supp 2):S50-S55. doi: 10.24875/GMM.18004578. Spanish.
- Background: PubMed 20484475Guerrero-Romero F, Simental-Mendia LE, Gonzalez-Ortiz M, Martinez-Abundis E, Ramos-Zavala MG, Hernandez-Gonzalez SO, Jacques-Camarena O, Rodriguez-Moran M. The product of triglycerides and glucose, a simple measure of insulin sensitivity. Comparison with the euglycemic-hyperinsulinemic clamp. J Clin Endocrinol Metab. 2010 Jul;95(7):3347-51. doi: 10.1210/jc.2010-0288. Epub 2010 May 19.
- BackgroundRodrigo-Cano S, Soriano Del Castillo JM, Merino-Torres JF. Causas y tratamiento de la obesidad. Nutricion Clinica y Dietetica Hospitalaria. 2017; 37(4):87-92.
- Background: PubMed 24463903Fonseca-Junior SJ, Sa CG, Rodrigues PA, Oliveira AJ, Fernandes-Filho J. Physical exercise and morbid obesity: a systematic review. Arq Bras Cir Dig. 2013;26 Suppl 1:67-73. doi: 10.1590/s0102-67202013000600015. English, Portuguese.
- Individual participant dataSharing planned: Yes. All data resulting from the clinical investigation, except the personal identification of the subjects (name, address, telephone, etc.)
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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 in people with Obesity and Drug Effect, 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 8 inclusion and 11 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 15 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 Hernández González, 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?
The effect of Triticum aestivum on glucose in patients with obesity (time frame: 120 days). The study lists 11 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 NCT06501248, 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 15 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.