Markers of InflammationHibiscusNCT05774613
Effect of Hibiscus Sabdariffa Beverage
A study testing Effect of a Hibiscus sabdariffa beverage in people with Markers of Inflammation and Hyperglycemia, Postprandial, run by Instituto Tecnológico y de Estudios Superiores de Occidente at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Markers of Inflammation, Hyperglycemia, Postprandial, Hyperinsulinism
- What is being tested?
- Effect of a Hibiscus sabdariffa beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteMexico
- Study dates
- 12 Jun 2021to 30 Jun 2023
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Hypertension
- Diabetes
- Smokers
- Cardiovascular disease
- Secondary hyperlipidemia
- Renal insufficiency
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
ITESO
Tlaquepaque, Jalisco, 45604
Edgar Jair Mendivil Rangel, PhD, +52 1 3335784872, MENDIVIL@iteso.mx
Luis Alejandro Arce Reynoso, MCA, +52 3111878707, lualarcere@ittepic.edu.mx
About this study
Official title: Bioavailability of Antioxidant Compounds and Effect on Markers of Inflammation by Ingestion of a Hibiscus Sabdariffa Beverage With Glicemic and Insulinemic Response
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.
Read the 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.
- Being tested
- Effect of a Hibiscus sabdariffa beverage
- Keywords
- Immunomodulator, Hypoglycemic, Inflammation, Post-prandial reponse, Glycemic Regulation
- Medical subject headings
- Hyperglycemia, Hyperinsulinism, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of a Hibiscus sabdariffa beverageDietary supplement
Hibiscus sabdariffa concentrate 60 mL from improved Mexican variety , administered on a single occasion
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | beverage with physical and sensory characteristics to the treatment beverage without the bioactive compounds corresponding to the study. Receives: Dietary Supplement: Effect of a Hibiscus sabdariffa beverage |
| Hibiscus-based drink | Experimental | beverage in patent process with application number MX/a/2022/010704 Receives: Dietary Supplement: Effect of a Hibiscus sabdariffa beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavalability of fenolics compunds and organic acids
identification and quantification of bioactive compounds in plasma and urine samples by HPLC-DAD-MS liquid chromatography.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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
measurements will be taken with the Inbody 770 equipment, whose results include weight, height, fat percentages and body muscle mass on the same day to evaluate the volunteers' measurements on the day of the intervention.
Measured: only measure
Food intake
Using Food Frecuency Quertionnaire and 24 hours reminder
Measured: 2 weeks for the response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start12 Jun 2021
- Primary completion13 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Markers of InflammationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Tecnológico y de Estudios Superiores de Occidente
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Tecnológico de Tepic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774613
- Sponsor's protocol ID
- Hibiscus Sabdariffa
- Acronym
- Hibiscus
- Status last verified
- Mar 2023
- First submitted
- 12 Jan 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All information provided by participant is strictly confidential, will be used only by the project's research team and will not be available for any other purpose. The results obtained from this study will be published for scientific purposes but the confidentiality of the participants will never be violated. The information or evidence obtained will be eliminated after fulfilling the scientific purposes for which this intervention was proposed.
Publications
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.
PubMed 3942088Sayago-Ayerdi SG, Goni I. [Hibiscus sabdariffa L: source of antioxidant dietary fiber]. Arch Latinoam Nutr. 2010 Mar;60(1):79-84. Spanish.
PubMed 21090279Marhuenda 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.
PubMed 31935957Hossain 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.
PubMed 33803802Janson 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.
PubMed 33721756Li 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.
PubMed 31137777Fernandez-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.
PubMed 35164041Achour 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.
PubMed 33509454Sayago-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.
PubMed 33992321
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Antioxidant Compounds and Effect on Markers of Inflammation by Ingestion of a Hibiscus Sabdariffa Beverage With Glicemic and Insulinemic Response
- ClinicalTrials.gov ID
- NCT05774613
- Acronym / sponsor ID
- Hibiscus / Hibiscus Sabdariffa
- Keywords
- Immunomodulator, Hypoglycemic, Inflammation, Post-prandial reponse, Glycemic Regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Instituto Tecnológico y de Estudios Superiores de OccidenteUniversity, hospital or other
- Collaborators
- Instituto Tecnológico de Tepic
- Study start
- 12 Jun 2021 (actual)
- Primary completion
- 13 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 17 Mar 2023 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Effect of a Hibiscus sabdariffa beveragebeverage with physical and sensory characteristics to the treatment beverage without the bioactive compounds corresponding to the study. |
| Hibiscus-based drink | Experimental | Dietary Supplement: Effect of a Hibiscus sabdariffa beveragebeverage in patent process with application number MX/a/2022/010704 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- Hypertension
- Diabetes
- Smokers
- Cardiovascular disease
- Secondary hyperlipidemia
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 |
|---|---|---|
| Effect of a Hibiscus sabdariffa beverageHibiscus sabdariffa concentrate 60 mL from improved Mexican variety , administered on a single occasion | Dietary supplement | Hibiscus-based drink, Placebo |
Primary outcome
Bioavalability of fenolics compunds and organic acids
Time frame: 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.
identification and quantification of bioactive compounds in plasma and urine samples by HPLC-DAD-MS liquid chromatography.
Glycemic response 0 minutes (preprandial) and de next repsponse at 15, 30, 45, 60, 90 and 120 minutes
Time frame: 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
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.
Insulinemic response 0 minutes (pre-prandial)
Time frame: The obtaining of the samples will be taken at 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)
Insulinemic response15 minutes
Time frame: The obtaining of the samples will be taken at 15 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)
Insulinemic response 30 minutes
Time frame: The obtaining of the samples will be taken at 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)
Insulinemic response 45minutes
Time frame: The obtaining of the samples will be taken at 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)
markers of inflammation IL-6
Time frame: 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
To perform an assay of inflammation markers by proquantum kit specifically interleukin-6 to visualize the decrease of these markers.
2 secondary outcomes
Anthropometry measurements
Time frame: only measure
Food intake
Time frame: 2 weeks for the response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Background: PubMed 3942088Wolever 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.
- Background: PubMed 21090279Sayago-Ayerdi SG, Goni I. [Hibiscus sabdariffa L: source of antioxidant dietary fiber]. Arch Latinoam Nutr. 2010 Mar;60(1):79-84. Spanish.
- Background: PubMed 31935957Marhuenda 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.
- Background: PubMed 33803802Hossain 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.
- Background: PubMed 33721756Janson 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.
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- Background: PubMed 35164041Fernandez-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.
- Background: PubMed 33509454Achour 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.
- Background: PubMed 33992321Sayago-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.
- Individual participant dataSharing planned: No. All information provided by participant is strictly confidential, will be used only by the project's research team and will not be available for any other purpose. The results obtained from this study will be published for scientific purposes but the confidentiality of the participants will never be violated. The information or evidence obtained will be eliminated after fulfilling the scientific purposes for which this intervention was proposed.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of a Hibiscus sabdariffa beverage in people with Markers of Inflammation and Hyperglycemia, Postprandial, run by Instituto Tecnológico y de Estudios Superiores de Occidente 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 12 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 17 Mar 2023. 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.
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 Edgar J. Mendivil, Doctor (011523335784872, mendivil@iteso.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavalability of fenolics compunds and organic acids (time frame: 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.). The study lists 7 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 NCT05774613, which also lists 9 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 17 Mar 2023.