UnknownNot Applicable

Effect of Hibiscus Sabdariffa Beverage

Mexico12 participantsStarted 2021-06-12

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Bioavalability of fenolics compunds and organic acids

Timeframe: 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

Timeframe: 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)

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

Insulinemic response15 minutes

Timeframe: The obtaining of the samples will be taken at 15 minutes

Insulinemic response 30 minutes

Timeframe: The obtaining of the samples will be taken at 30 minutes

Insulinemic response 45minutes

Timeframe: The obtaining of the samples will be taken at 45minutes

Trial details

NCT IDNCT05774613

SponsorInstituto Tecnológico y de Estudios Superiores de Occidente

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-13

Contact for this trial

Edgar J. Mendivil, Doctor

011523335784872 mendivil@iteso.mx

View on ClinicalTrials.gov More Markers of Inflammation trials