Effect of Triticum Aestivum vs Placebo on Metabolic Profile Components and Insulin Sensitivity in Patients With Obesity
NCT ID: NCT06501248
Last Updated: 2024-07-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE3
Total Enrollment
36 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-07-14
Study Completion Date
2024-12-10
Brief Summary
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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.
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.
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Detailed Description
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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
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Obesity
Drug Effect
Insulin Sensitivity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
All participants will be submitted to the selection of a sealed envelope which will have a numerical code previously defined by a third party for each intervention group.
The total number of envelopes required to complete the minimum number of participants will have numerical codes that identify the bottle of intervention treatment that should receive the participant during the intervention period.
They will be divided into half blinded codes for triticum aestivum group and half for placebo to complete the size of each subsample. Chance guarantees blinding, neither the participant nor the researcher will know the type of treatment. The database for the blinded statistical analysis will be completed. The blind man will be removed once the statistical analysis has been completed.
The total number of envelopes required to complete the minimum number of participants will have numerical codes that identify the bottle of intervention treatment that should receive the participant during the intervention period.
They will be divided into half blinded codes for triticum aestivum group and half for placebo to complete the size of each subsample. Chance guarantees blinding, neither the participant nor the researcher will know the type of treatment. The database for the blinded statistical analysis will be completed. The blind man will be removed once the statistical analysis has been completed.
Study Groups
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Triticum aestivum
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.
Group Type
ACTIVE_COMPARATOR
Triticum Aestivum
Intervention Type
DRUG
The intervention period will be 120 days, searching for effects on insulin sensitivity and metabolic control.
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.
Group Type
PLACEBO_COMPARATOR
Placebo (calcined magnesia)
Intervention Type
DRUG
The intervention period will be 120 days, searching for effects on insulin sensitivity and metabolic control.
Interventions
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Triticum Aestivum
The intervention period will be 120 days, searching for effects on insulin sensitivity and metabolic control.
Intervention Type
DRUG
Placebo (calcined magnesia)
The intervention period will be 120 days, searching for effects on insulin sensitivity and metabolic control.
Intervention Type
DRUG
Other Intervention Names
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Calcined magnesia
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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.
* 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)
* 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.
* 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)
Minimum Eligible Age
30 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Coordinación de Investigación en Salud, Mexico
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Sandra O Hernández González, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social, Unidad de Investigación Biomédica 02
Locations
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Biomedical Unit Research 02, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Social Security Institute.
Guadalajara, Jalisco, Mexico
Site Status
RECRUITING
Countries
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Mexico
Central Contacts
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Facility Contacts
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References
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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.
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Aktar 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.
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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.
Reference Type
BACKGROUND
Moreno-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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Ahmed 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.
Reference Type
BACKGROUND
Roberts 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.
Reference Type
BACKGROUND
D'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.
Reference Type
BACKGROUND
Almeda-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.
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BACKGROUND
Guerrero-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.
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BACKGROUND
Rodrigo-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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Daneschvar 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.
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BACKGROUND
Kushner 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.
Reference Type
BACKGROUND
Moshawih 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.
Reference Type
BACKGROUND
Singh N, Verma P, Pandey BR. Therapeutic Potential of Organic Triticum aestivum Linn. (Wheat Grass) in Prevention and Treatment of Chronic Diseases: An Overview [Internet]. Vol. 4, International Journal of Pharmaceutical Sciences and Drug Research. 2012. Available from: www.ijpsdr.com
Reference Type
BACKGROUND
Anup S. PHYTOCHEMICAL AND PHARMACOLOGICAL SCREENING OF WHEATGRASS JUICE (TRITICUM AESTIVUM L.). International Journal of Pharmaceutical Sciences Review and Research. 2011; 9(1):159-64.
Reference Type
BACKGROUND
Leoncini E, Prata C, Malaguti M, Marotti I, Segura-Carretero A, Catizone P, Dinelli G, Hrelia S. Phytochemical profile and nutraceutical value of old and modern common wheat cultivars. PLoS One. 2012;7(9):e45997. doi: 10.1371/journal.pone.0045997. Epub 2012 Sep 26.
Reference Type
BACKGROUND
Luyen 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.
Reference Type
BACKGROUND
Amira Moheb T. Biochemical, Molecular and Pharmacological Studies of the Wheat (Triticum aestivum L). 2012.
Reference Type
BACKGROUND
Kothari S, Jain AK, Mehta SC, Tonpay SD. Hypolipidemic effect of fresh Triticum aestivum (wheat) grass juice in hypercholesterolemic rats. Acta Pol Pharm. 2011 Mar-Apr;68(2):291-4.
Reference Type
BACKGROUND
Mohan Y, Jesuthankaraj GN, Ramasamy Thangavelu N. Antidiabetic and Antioxidant Properties of Triticum aestivum in Streptozotocin-Induced Diabetic Rats. Adv Pharmacol Sci. 2013;2013:716073. doi: 10.1155/2013/716073. Epub 2013 Dec 14.
Reference Type
BACKGROUND
Shakya G, Randhi PK, Pajaniradje S, Mohankumar K, Rajagopalan R. Hypoglycaemic role of wheatgrass and its effect on carbohydrate metabolic enzymes in type II diabetic rats. Toxicol Ind Health. 2016 Jun;32(6):1026-32. doi: 10.1177/0748233714545202. Epub 2014 Aug 12.
Reference Type
BACKGROUND
Im 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.
Reference Type
BACKGROUND
Ajiboye BO, Oloyede HOB, Salawu MO. Antidiabetic Activity of Triticum aestivum Seed-Based Diet on Alloxan-Induced Diabetic Rats. J Diet Suppl. 2020;17(2):133-149. doi: 10.1080/19390211.2018.1492485. Epub 2018 Oct 4.
Reference Type
BACKGROUND
Other Identifiers
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R-2022-1301-178
Identifier Type: -
Identifier Source: org_study_id
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