Effect of Hibiscus Sabdariffa Beverage

NCT05774613 | Unknown

• 1 other identifier: Hibiscus Sabdariffa
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

There are numerous plant foods that are a source of bioactive compounds, which can induce an anti-inflammatory effect on various pathways of inflammatory processes in the body as it may be useful in decreasing markers of inflammation expressed by COVID-19 infectious disease and conditions such as obesity and its comorbidities. Given the above, Hibiscus sabdariffa hibiscus possesses advantages as a potential adjuvant in the management of COVID-19, as studies on the phytochemical properties of H. sabdariffa show that it has several health benefits, and could be used as a potent material for the therapeutic treatment of various diseases. Due to its high content of bioactive compounds, these can exert antioxidant, anti-inflammatory and anticarcinogenic effects, as well as help control blood glucose levels, prevent cardiovascular disease and obesity. In addition, it is a traditional component of the Mexican diet, of common consumption, easy incorporation in the diet, versatility in preparation and national production. Therefore, to evaluate the bioavailability of bioactive compounds present in a beverage developed from the TECNM/ITESO collaboration, as well as the glycemic and insulinemic response produced by its consumption; besides establishing the effect on some inflammation markers that may be activated as a consequence of the SARS-COV-2 virus infection. This will help to increase knowledge about potential treatment/prevention schemes, avoid the development of severe manifestations of the disease, as well as boost the production and market of a national product.

Conditions

Markers of Inflammation; Hyperglycemia, Postprandial; Hyperinsulinism

Keywords

Immunomodulator; Hypoglycemic; Inflammation; Post-prandial reponse; Glycemic Regulation

Outcome Measures

Primary Outcomes (7)

• Bioavalability of fenolics compunds and organic acids

  identification and quantification of bioactive compounds in plasma and urine samples by HPLC-DAD-MS liquid chromatography.

  the time period will be determined in a single day by evaluating absorption at 0, 0.5, 1, 2, 3, 4, 5 and 6 hours in plasma and for urine its excretion evaluated at 0, 3, 6, 12, 24 hours.

• Glycemic response 0 minutes (preprandial) and de next repsponse at 15, 30, 45, 60, 90 and 120 minutes

  To obtain the biological sample, a lancet will be used to puncture the pad of the voluntary finger and the sample will be collected in high-sensitivity reactive strips for the measurement of capillary glucose of the OneTouch Ultra System. The portable systeme used for pre- and postprandial glucose measurement allows the monitoring of the capillary glycemic response under experimental conditions for healthy subjects. With the use of this equipment, preprandial and postprandial measurements will be obtained.

  With the use of this equiment, measurements will be obtained from 0 minutes (preprandial) and at 15, 30, 45, 60, 90 and 120 minutes (postprandial) response

• Insulinemic response 0 minutes (pre-prandial)

  Blood samples will be drawn via capillary puncture. Measurements over time will be similar to the glycemic response assessment techniqeu. Samples will be placed in BD Microtainer SST tubes and kept at room temperature for 30 min. The samples will be centrifucated to obtain serum. Serum insulin concentrations will be analyzed using a solid-phase two-site enzyme immunoassay kit (Human Insulin ElLISA kit, Millipore, EZHI-14K)

  The obtaining of the samples will be taken at 0 minutes (pre-prandial)

• Insulinemic response15 minutes

  Blood samples will be drawn via capillary puncture. Measurements over time will be similar to the glycemic response assessment techniqeu. Samples will be placed in BD Microtainer SST tubes and kept at room temperature for 30 min. The samples will be centrifucated to obtain serum. Serum insulin concentrations will be analyzed using a solid-phase two-site enzyme immunoassay kit (Human Insulin ElLISA kit, Millipore, EZHI-14K)

  The obtaining of the samples will be taken at 15 minutes

• Insulinemic response 30 minutes

  Blood samples will be drawn via capillary puncture. Measurements over time will be similar to the glycemic response assessment techniqeu. Samples will be placed in BD Microtainer SST tubes and kept at room temperature for 30 min. The samples will be centrifucated to obtain serum. Serum insulin concentrations will be analyzed using a solid-phase two-site enzyme immunoassay kit (Human Insulin ElLISA kit, Millipore, EZHI-14K)

  The obtaining of the samples will be taken at 30 minutes

• Insulinemic response 45minutes

  Blood samples will be drawn via capillary puncture. Measurements over time will be similar to the glycemic response assessment techniqeu. Samples will be placed in BD Microtainer SST tubes and kept at room temperature for 30 min. The samples will be centrifucated to obtain serum. Serum insulin concentrations will be analyzed using a solid-phase two-site enzyme immunoassay kit (Human Insulin ElLISA kit, Millipore, EZHI-14K)

  The obtaining of the samples will be taken at 45minutes

• markers of inflammation IL-6

  To perform an assay of inflammation markers by proquantum kit specifically interleukin-6 to visualize the decrease of these markers.

  The blood samples will take with the help of collecting tubes by venous puncture, with 8 samples, t=0, then at 30 minutes, 1, 2, 3, 4 5 and 6 hours and Urine samples will be collected at 0, 3,6, 12, 24 hours

Secondary Outcomes (2)

• Anthropometry measurements

  only measure

• Food intake

  2 weeks for the response

Study Arms (2)

Placebo

PLACEBO COMPARATOR

beverage with physical and sensory characteristics to the treatment beverage without the bioactive compounds corresponding to the study.

Dietary Supplement: Effect of a Hibiscus sabdariffa beverage

Hibiscus-based drink

EXPERIMENTAL

beverage in patent process with application number MX/a/2022/010704

Dietary Supplement: Effect of a Hibiscus sabdariffa beverage

Interventions

Effect of a Hibiscus sabdariffa beverage DIETARY_SUPPLEMENT

Hibiscus sabdariffa concentrate 60 mL from improved Mexican variety , administered on a single occasion

Hibiscus-based drink; Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normolipidemia Total cholesterol (plasma) \< 200 mg/L-1
• Triglycerides \< 150 mg/L-1
• Normoglycemia Fasting glucose (plasma) \< 100 mg/L-1
• IMC \[kg/m2\]1 18.5 - 24.9
• Abdominal circumference \[cm\] Men\<90 Women \< 80
• Percentage of fat \[%\] Men\<19 Women \< 33Systolic pressure \[mmHg\] \< 140
• Diastolic pressure \[mmHg\] \< 90
• Alcohol Last consumption one and a half weeks

You may not qualify if:

• Hypertension
• Diabetes
• Smokers
• Cardiovascular disease
• Secondary hyperlipidemia
• Renal insufficiency
• Hyperthyroidism
• In diet
• Pregnant or lactating women, and if their menstrual cycle is close (1 week)
• In medical treatment / supplements
• Hepatic insufficiency
• Infection / inflammatory disease (6 weeks prior to study)

Sponsors & Collaborators

• Instituto Tecnológico y de Estudios Superiores de Occidente: lead
• Instituto Tecnológico de Tepic: collaborator

Study Sites (1)

ITESO

Tlaquepaque, Jalisco, 45604, Mexico

RECRUITING

Related Publications (9)

• Wolever TM, Jenkins DJ. The use of the glycemic index in predicting the blood glucose response to mixed meals. Am J Clin Nutr. 1986 Jan;43(1):167-72. doi: 10.1093/ajcn/43.1.167.

  PMID: 3942088 BACKGROUND

• Sayago-Ayerdi SG, Goni I. [Hibiscus sabdariffa L: source of antioxidant dietary fiber]. Arch Latinoam Nutr. 2010 Mar;60(1):79-84. Spanish.

  PMID: 21090279 BACKGROUND

• Marhuenda J, Perez S, Victoria-Montesinos D, Abellan MS, Caturla N, Jones J, Lopez-Roman J. A Randomized, Double-Blind, Placebo Controlled Trial to Determine the Effectiveness a Polyphenolic Extract (Hibiscus sabdariffa and Lippia citriodora) in the Reduction of Body Fat Mass in Healthy Subjects. Foods. 2020 Jan 6;9(1):55. doi: 10.3390/foods9010055.

  PMID: 31935957 BACKGROUND

• Hossain MM, Tovar J, Cloetens L, Florido MTS, Petersson K, Prothon F, Nilsson A. Oat Polar Lipids Improve Cardiometabolic-Related Markers after Breakfast and a Subsequent Standardized Lunch: A Randomized Crossover Study in Healthy Young Adults. Nutrients. 2021 Mar 18;13(3):988. doi: 10.3390/nu13030988.

  PMID: 33803802 BACKGROUND

• Janson B, Prasomthong J, Malakul W, Boonsong T, Tunsophon S. Hibiscus sabdariffa L. calyx extract prevents the adipogenesis of 3T3-L1 adipocytes, and obesity-related insulin resistance in high-fat diet-induced obese rats. Biomed Pharmacother. 2021 Jun;138:111438. doi: 10.1016/j.biopha.2021.111438. Epub 2021 Mar 13.

  PMID: 33721756 BACKGROUND

• Li S, Wu B, Fu W, Reddivari L. The Anti-inflammatory Effects of Dietary Anthocyanins against Ulcerative Colitis. Int J Mol Sci. 2019 May 27;20(10):2588. doi: 10.3390/ijms20102588.

  PMID: 31137777 BACKGROUND

• Fernandez-Ochoa A, Cadiz-Gurrea ML, Fernandez-Moreno P, Rojas-Garcia A, Arraez-Roman D, Segura-Carretero A. Recent Analytical Approaches for the Study of Bioavailability and Metabolism of Bioactive Phenolic Compounds. Molecules. 2022 Jan 25;27(3):777. doi: 10.3390/molecules27030777.

  PMID: 35164041 BACKGROUND

• Achour M, Bravo L, Sarria B, Ben Fredj M, Nouira M, Mtiraoui A, Saguem S, Mateos R. Bioavailability and nutrikinetics of rosemary tea phenolic compounds in humans. Food Res Int. 2021 Jan;139:109815. doi: 10.1016/j.foodres.2020.109815. Epub 2020 Oct 20.

  PMID: 33509454 BACKGROUND

• Sayago-Ayerdi SG, Venema K, Tabernero M, Sarria B, Bravo L, Mateos R. Bioconversion of polyphenols and organic acids by gut microbiota of predigested Hibiscus sabdariffa L. calyces and Agave (A. tequilana Weber) fructans assessed in a dynamic in vitro model (TIM-2) of the human colon. Food Res Int. 2021 May;143:110301. doi: 10.1016/j.foodres.2021.110301. Epub 2021 Mar 10.

  PMID: 33992321 BACKGROUND

MeSH Terms

Conditions

Hyperglycemia; Hyperinsulinism; Inflammation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Edgar J. Mendivil, Doctor

CONTACT

011523335784872; mendivil@iteso.mx

Sonia G. Sáyago, Doctor

CONTACT

011523111120894; ssayago@ittepic.edu.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trial in which both treatments under study (experimental and control) are administered to each patient at successive administered to each patient in successive periods that have been randomly determined, allowing each subject to be his or her own control. Randomly determined, allowing each subject to be his or her own control.

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: March 17, 2023
• Study Start: June 12, 2021
• Primary Completion: June 13, 2023
• Study Completion: June 30, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)