Effect of Hibiscus Sabdariffa Beverage

NCT ID: NCT05774613

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-12
• Study Completion Date: 2023-06-30

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.

Detailed Description

The following study will be carried out in two stages where an acute single-blind, crossover, randomized, single-blind clinical study will be performed, where 12 volunteers between 18 and 40 years of age, normal weight (BMI 18.5-24.9 kg/m2), without existing pathologies and/or with pharmacological treatment will be required. The characteristics of the study will be explained to the volunteers beforehand, and those who agree with the specifications will sign the informed consent form and become candidates to participate. The study will consist of the administration of a treatment drink based on hibiscus (H. sabdariffa), controlled with a placebo drink, both with a volume of 60 ml.

The first stage will consist of the selection of volunteers who will undergo two interventions. On the day of the 1st intervention, participants will arrive at 7 a.m., central time in Mexico, with an overnight fast of 10-12heures . Prior to the intervention, the clinical history including anthropometric measurements and dietary questionnaire (24eures reminder) will be filled out and participants will be asked to rest for 30 min prior to taking their blood pressure at the time of admission, and they should be seated, upright and with their feet on the floor during the process; the measurement will be performed using a manometer on the left arm, elevated at the level of the heart. Afterwards, samples (urine and blood) were taken. Those corresponding to urine will be taken a basal sample (T=0) in a collection bottle. Once the hibiscus-based drink or placebo is ingested, samples will be collected at the following times: 3h, 6h, 12h and 24h. The samples corresponding to blood will be collected with the help of collecting tubes by venous puncture. Eight samples were taken, the first one at the arrival of the patients being basal time (T=B), then at 30 minutes (T=2), 1heure (T=3), 1:30heures (T=4), 2heures (T=5), 3heures (T=6), 4heures (T=7) and 6heures (T=8) after having ingested the hibiscus-based drink or the placebo. During the intervention the volunteers will receive a Western-type diet after the consumption of the beverage, characterized by excessive consumption of red meat, simple carbohydrates, ultra-processed products, colorants, saturated fats, refined sugars and very little intake of fiber and vitamins. After a washout period of more than 6 days, the participants will undergo a second intervention with a different product than the first time (beverage to be evaluated or placebo as appropriate), and the sampling will be repeated.

The second stage will correspond to the evaluation of the glycemic response (GR) and insulinemic response (IR) of the selected individuals. For this purpose, volunteers should come with homogenized dietary conditions (normocaloric and carbohydrate-controlled diet (300 g/day)), without having performed intense physical activity and with a fasting state of 12 hours; In the place they will consume the treatment drink (BT) and the placebo drink (BP) of 60 mL, accompanied by a portion of white bread, so that the sum of the drink plus the white bread will be 50 g of carbohydrates, the administration of the type of drink will be carried out in different sessions, separated by a washout period of 7 days, so that the participants will consume a different one in each session. The RG and RI will be evaluated at time 0 (preprandial), and at 15, 30, 45, 60, 90, and 120 minutes (postprandial), through capillary blood obtained by fingertip puncture. The evaluation corresponding to the GR will be done by taking the second drop and placing it on highly sensitive test strips of the OneTouch Ultra® System, continuing with the determination of the RI through the collection of blood in BD Microtainer SST tubes, which will be centrifuged for 10 minutes (5000 rpm, 25°C) to obtain the serum, which will be used when employing an ELISA human insulin kit.

The study will be carried out at the Nutricia clinic located in Building M of the Instituto Tecnológico y de Estudios Superiores de Occidente (ITESO) located at Anillo Perif. Sur Manuel Gómez Morín 8585, Santa María Tequepexpan, 45604 Tlaquepaque, Jalisco.

Conditions

Markers of Inflammation; Hyperglycemia, Postprandial; Hyperinsulinism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Effect of a Hibiscus sabdariffa beverage

Intervention Type: DIETARY_SUPPLEMENT

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

Hibiscus-based drink

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

Group Type: EXPERIMENTAL

Effect of a Hibiscus sabdariffa beverage

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Effect of a Hibiscus sabdariffa beverage

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Tecnológico de Tepic

UNKNOWN

Sponsor Role: collaborator

Instituto Tecnológico y de Estudios Superiores de Occidente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ITESO

Tlaquepaque, Jalisco, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Edgar J. Mendivil, Doctor

Role: CONTACT

mendivil@iteso.mx

011523335784872

Sonia G. Sáyago, Doctor

Role: CONTACT

ssayago@ittepic.edu.mx

011523111120894

Facility Contacts

Edgar Jair Mendivil Rangel, PhD

Role: primary

MENDIVIL@iteso.mx

+52 1 3335784872

Luis Alejandro Arce Reynoso, MCA

Role: backup

lualarcere@ittepic.edu.mx

+52 3111878707

References

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.

Reference Type: BACKGROUND

PMID: 3942088 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 21090279 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31935957 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 33803802 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 35164041 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 33992321 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Hibiscus Sabdariffa

Identifier Type: -

Identifier Source: org_study_id