ObesityNCT04555447
Gastrointestinal Tolerability to Agavins and Impact on Host-gut Microbiota-metabolism Interactions Modulation
A study testing Agavins (prebiotic fiber) in people with Obesity and Healthy, run by Centro De Investigación Y De Estudios Avanzados Del Instituto Politécnico Nacional-Unidad Irapuato at 2 sites in Mexico.
Trial summary
Agavins are branched neo-fructans and prebiotic fiber found in Agave plants. In preclinical studies, agavins have demonstrated an effect in reversing metabolic disorders associated to overweight and obesity through the modulation of gut microbiota activity and composition, showing their interesting potential in the… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Agavins (prebiotic fiber)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesMexico
- Study dates
- 22 Mar 2019to 7 Sep 2019
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females
- Age 30 - 60 years
- BMI ≥ 30 kg/m2
- Stable body weight for at least 1 month prior to the study
Who cannot join
- Type 1 and type 2 diabetes
- Hypothyroidism
- Currently following a weight loss diet or physical activity regime for the same purpose
- Weight loss >3 kg within 3 months before enrollment
- Use of prebiotics, probiotics, or dietary fiber supplements
- Long-term (and within the preceding month) use of antioxidants, omega-3, and omega-6 fatty acids supplements
Show all 25Show fewer
- Strenuous exercise (>3 hours/week)
- Concomitant use of any medication influencing appetite, weight, metabolism
- Use of metformin
- Antibiotic use 1 week prior to the study
- Alcohol or substance abuse
- Diagnosis of neurological or psychiatric disorders, like anxiety, depression, Attention-Deficit/Hyperactivity Disorder (ADHD), schizophrenia
- Active smoker
- Alanine Transaminase (ALT) and Aspartate Aminotransferase (AST) enzymes concentration >2.5 times the highest limit value
- Creatinine >1.2 mg/dL
- Women: pregnancy or lactation
- Previous intestinal or bariatric surgery
- Heart, brain, or thyroid surgeries within the preceding 6 months
- History of liver or pancreatic disease
- History of renal failure
- Intestinal absorption disorder
- Inflammatory bowel disease
- Established cardiovascular disease
- Active or history of neoplasia within the preceding 5 years
- Chronic use of bulk laxatives and antacids
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional-Unidad Irapuato (CINVESTAV-UI)
Irapuato, Guanajuato, 36824
Centro de Estudios Cardiometabólicos S.C. (CESCAM)
Mexico City, 07760
About this study
Official title: Gastrointestinal Tolerability to Increasing Doses of Agavins and Impact on Gut Microbiota, Fecal Metabolites, and Metabolic Biomarkers in Healthy and Obese Subjects
Agavins are branched neo-fructans and prebiotic fiber found in Agave plants. In preclinical studies, agavins have demonstrated an effect in reversing metabolic disorders associated to overweight and obesity through the modulation of gut microbiota activity and composition, showing their interesting potential in the context of high obesity and cardiovascular diseases prevalence in Mexican population. However, current information about gastrointestinal adaptation and effects of agavins intake in humans is scarce. We hypothesized that increasing amounts of agavins up to 12 g/day, will be well tolerated by healthy and obese adult participants, but with differences between these groups, modulating gut microbiota activity and structure differentially, as well as the metabolic status after a 5-week dose-escalation intervention.
Read the detailed description
Diet has dramatically changed over the past decades with increased consumption of high-fat, high-sugar, high-sodium processed and refined foods, but with low or very low fiber-rich products. Microbiota-accessible carbohydrates (MACs) found for example in dietary fiber have been recognized as crucial for the microbial ecosystem in the gut; the lack of these available carbohydrates depletes the microbial community, causing alterations in its composition and performance. Perturbations in the gut microbiota have been related with several diseases, so as reduction in dietary fiber has been linked with an increased risk for developing chronic diseases, namely cardiovascular and metabolic ones, such as obesity and type 2 diabetes. Mexico is the second country with the highest obesity rates worldwide, which represents a major national public health challenge. Interestingly, national nutrition surveys have found that Mexican adults consume less than half the dietary intake recommendation for fiber, along with an alarming statistic of 7 in 10 adults being overweight or obese.
A change in dietary patterns intended to achieve adequate nutrient intake, dietary fiber included, is one strategy that could help modify this nutrition trend in the country, but another accessible alternative is the supplementation of prebiotic fiber, thus increasing fiber consumption and avoiding gut microbiota alterations simultaneously. Prebiotics, such as fructans, are substrates selectively used by gut microbes, modifying their activity and/or community composition, and conferring health benefits to the host. Clinical research has demonstrated their impact in reducing body weight, fat mass, hyperlipidemia, etc. Agave prebiotics, also known as agavins, are fructan-type carbohydrates that possess a unique molecular structure and are extracted as a complex multi-disperse mixture presenting different degrees of polymerization and/or branching. Previously, agavins have shown to induce weight loss, a significant reduction in glucose and total cholesterol levels, and promotion of satiety-related hormones in overweight mice through the increment in short-chain fatty acids (SCFA) and specific modulation of gut microbiota; more recently, fecal metabolomics have revealed interesting microbial-derived metabolites, detected after agavins supplementation in mouse models that could induce a beneficial effect on host health, but more research is needed.
Experts have stated that differences in dietary fiber structure guide its degradation: which microbes can metabolize these substrates, and the effects in the microbial community that overall, impact health. Additionally, structural differences in prebiotic fibers like agavins, may cause specific gastrointestinal (GI) adaptation and tolerance which is of great importance to promote their consumption and in determining an ideal amount or dose to further explore their impact.
In this study we propose a double-blind, placebo controlled, parallel groups, dose-escalation trial, where lean and obese subjects were assigned to either agavins or placebo group for a 5-week dose-escalation period. We aim to evaluate the evolution of GI tolerability and compared the records between lean and obese participants (Mexican adults), the impact in gut microbiota composition and activity through the determination of short-chain fatty acids and fecal metabolites, and metabolic status, all of this after a short period of time proposed to induce adaptation to agavins intake.
- Being tested
- Agavins (prebiotic fiber), Placebo
- Keywords
- Prebiotics, Agavins, Gastrointestinal tolerability, Obesity, Gut microbiota, SCFA, Fecal metabolites, Agave dietary fiber
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agavins (prebiotic fiber)Dietary supplement
Also called Agave inulin (Preventy)
Agavins contained in ready-to-use sachets were dissolved in water, and participants consumed the corresponding dose daily (2.5, 5.0, 7.0, 10 or 12 g) for 1 week, preferentially in the evening. Participants followed a 5-week dose-escalation intervention.
PlaceboDietary supplement
Also called Maltodextrin (Globe 10 IP)
Maltodextrin contained in ready-to-use sachets was dissolved in water, and participants consumed the corresponding dose daily (2.5, 5.0, 7.0, 10 or 12 g) for 1 week, preferentially in the evening. Participants followed a 5-week dose-escalation intervention.
| Study group | Role | What they receive |
|---|---|---|
| Healthy-agavins | Experimental | Agavins are branched neo-fructans and were supplemented for a 5-week dose-escalation period in lean participants Receives: Dietary Supplement: Agavins (prebiotic fiber) |
| Healthy-placebo | Placebo comparator | Maltodextrin was used as placebo and supplemented for a 5-week dose-escalation period in lean participants Receives: Dietary Supplement: Placebo |
| Obese-agavins | Experimental | Agavins are branched neo-fructans that were supplemented for a 5-week dose-escalation period in obese participants Receives: Dietary Supplement: Agavins (prebiotic fiber) |
| Obese-placebo | Placebo comparator | Maltodextrin was used as placebo and supplemented for a 5-week dose-escalation period in obese participants Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerability
Five gastrointestinal symptoms related to tolerability (flatulence, bloating, borborygmi, diarrhea, and abdominal pain) were assessed by a 10-cm Visual Analog Scale (VAS), guided by "no effect" (0 cm) , "moderate effect" (5 cm), and "worst effect possible" (10 cm). Participants rated their feelings 12 hours after taking their daily dose of dietary supplement, at the same time every day. All VAS were provided as printed material, one scale for each gastrointestinal symptom.
Measured: 0-5 weeks
Secondary outcomes (4)
Appetite and satiety subjective assessment
Appetite and satiety feelings were assessed by a 10-cm Visual Analog Scale (VAS). Appetite ratings were guided by "How hungry do you feel?" anchored by "I am not hungry at all" and "I have never been hungrier; I have to eat immediately". Satiety ratings were guided by "How satisfied do you feel?" anchored by "I feel my stomach completely empty" and "I cannot eat another bite". Participants rated their feelings 12 hours after taking their daily dose of dietary supplement, at the same time every day. Each VAS was provided as printed material.
Measured: 0-5 weeks
Gut microbiota composition
Gut microbiota composition was assessed by 16S rRNA sequencing
Measured: 5 weeks
SCFA production
Short-chain fatty acids (SCFA) production was determined in feces by Gas Chromatography-Flame Ionization Detector (GC-FID), and expressed as SCFA concentration (µmol/g)
Measured: 5 weeks
Fecal metabolomics
Fecal metabolomics will be performed by Gas Chromatography-Mass Spectrometry (GC-MS) . Ordination methods and statistical dimension reduction techniques such as Principal Component Analysis (PCA), Partial Least Square-Discriminant Analysis (PLS-DA), as well as hierarchical clustering analysis will be implemented to explore and identify clusters of samples, groups.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start22 Mar 2019
- Primary completion7 Sep 2019
- Study completion7 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy and obese participants randomized into agavins (prebiotic fiber) or placebo group received the corresponding dietary supplement simultaneously
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro De Investigación Y De Estudios Avanzados Del Instituto Politécnico Nacional-Unidad Irapuato
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Estudios Cardiometabólicos S.C. (CESCAM), Inulina y Miel de Agave S.A. de C.V. (IMAG)
- Responsible party
- Principal investigator, Mercedes G. López, Centro De Investigación Y De Estudios Avanzados Del Instituto Politécnico Nacional-Unidad Irapuato
- Investigators
- Mercedes G. López, PhD, Study director, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional-UI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555447
- Sponsor's protocol ID
- CINVESTAV-IRA-BYB-171018
- Status last verified
- Sep 2020
- First submitted
- 28 Aug 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be published in a peer-reviewed journal in the fields of dietetics and nutrition, with impact factor according to the Journal Citation Reports.
Publications
Huazano-Garcia A, Shin H, Lopez MG. Modulation of Gut Microbiota of Overweight Mice by Agavins and Their Association with Body Weight Loss. Nutrients. 2017 Aug 23;9(9):821. doi: 10.3390/nu9090821.
PubMed 28832493Franco-Robles E, Lopez MG. Agavins Increase Neurotrophic Factors and Decrease Oxidative Stress in the Brains of High-Fat Diet-Induced Obese Mice. Molecules. 2016 Aug 2;21(8):998. doi: 10.3390/molecules21080998.
PubMed 27490526Huazano-Garcia A, Lopez MG. Agavins reverse the metabolic disorders in overweight mice through the increment of short chain fatty acids and hormones. Food Funct. 2015 Dec;6(12):3720-7. doi: 10.1039/c5fo00830a. Epub 2015 Sep 3.
PubMed 26333285Santiago-Garcia PA, Lopez MG. Agavins from Agave angustifolia and Agave potatorum affect food intake, body weight gain and satiety-related hormones (GLP-1 and ghrelin) in mice. Food Funct. 2014 Dec;5(12):3311-9. doi: 10.1039/c4fo00561a.
PubMed 25367106Garcia-Vieyra MI, Del Real A, Lopez MG. Agave fructans: their effect on mineral absorption and bone mineral content. J Med Food. 2014 Nov;17(11):1247-55. doi: 10.1089/jmf.2013.0137. Epub 2014 Jul 28.
PubMed 25069021Urias-Silvas JE, Cani PD, Delmee E, Neyrinck A, Lopez MG, Delzenne NM. Physiological effects of dietary fructans extracted from Agave tequilana Gto. and Dasylirion spp. Br J Nutr. 2008 Feb;99(2):254-61. doi: 10.1017/S0007114507795338. Epub 2007 Aug 22.
PubMed 17711612
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Tolerability to Increasing Doses of Agavins and Impact on Gut Microbiota, Fecal Metabolites, and Metabolic Biomarkers in Healthy and Obese Subjects
- ClinicalTrials.gov ID
- NCT04555447
- Acronym / sponsor ID
- CINVESTAV-IRA-BYB-171018
- Keywords
- Prebiotics, Agavins, Gastrointestinal tolerability, Obesity, Gut microbiota, SCFA, Fecal metabolites, Agave dietary fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centro De Investigación Y De Estudios Avanzados Del Instituto Politécnico Nacional-Unidad IrapuatoUniversity, hospital or other
- Collaborators
- Centro de Estudios Cardiometabólicos S.C. (CESCAM), Inulina y Miel de Agave S.A. de C.V. (IMAG)
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 7 Sep 2019 (actual)
- Study completion
- 7 Sep 2019 (actual)
- First posted
- 18 Sep 2020 (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.
Agavins are branched neo-fructans and prebiotic fiber found in Agave plants. In preclinical studies, agavins have demonstrated an effect in reversing metabolic disorders associated to overweight and obesity through the modulation of gut microbiota activity and composition, showing their interesting potential in the context of high obesity and cardiovascular diseases prevalence in Mexican population. However, current information about gastrointestinal adaptation and effects of agavins intake in humans is scarce. We hypothesized that increasing amounts of agavins up to 12 g/day, will be well tolerated by healthy and obese adult participants, but with differences between these groups, modulating gut microbiota activity and structure differentially, as well as the metabolic status after a 5-week dose-escalation intervention.
Detailed description
Diet has dramatically changed over the past decades with increased consumption of high-fat, high-sugar, high-sodium processed and refined foods, but with low or very low fiber-rich products. Microbiota-accessible carbohydrates (MACs) found for example in dietary fiber have been recognized as crucial for the microbial ecosystem in the gut; the lack of these available carbohydrates depletes the microbial community, causing alterations in its composition and performance. Perturbations in the gut microbiota have been related with several diseases, so as reduction in dietary fiber has been linked with an increased risk for developing chronic diseases, namely cardiovascular and metabolic ones, such as obesity and type 2 diabetes. Mexico is the second country with the highest obesity rates worldwide, which represents a major national public health challenge. Interestingly, national nutrition surveys have found that Mexican adults consume less than half the dietary intake recommendation for fiber, along with an alarming statistic of 7 in 10 adults being overweight or obese.
A change in dietary patterns intended to achieve adequate nutrient intake, dietary fiber included, is one strategy that could help modify this nutrition trend in the country, but another accessible alternative is the supplementation of prebiotic fiber, thus increasing fiber consumption and avoiding gut microbiota alterations simultaneously. Prebiotics, such as fructans, are substrates selectively used by gut microbes, modifying their activity and/or community composition, and conferring health benefits to the host. Clinical research has demonstrated their impact in reducing body weight, fat mass, hyperlipidemia, etc. Agave prebiotics, also known as agavins, are fructan-type carbohydrates that possess a unique molecular structure and are extracted as a complex multi-disperse mixture presenting different degrees of polymerization and/or branching. Previously, agavins have shown to induce weight loss, a significant reduction in glucose and total cholesterol levels, and promotion of satiety-related hormones in overweight mice through the increment in short-chain fatty acids (SCFA) and specific modulation of gut microbiota; more recently, fecal metabolomics have revealed interesting microbial-derived metabolites, detected after agavins supplementation in mouse models that could induce a beneficial effect on host health, but more research is needed.
Experts have stated that differences in dietary fiber structure guide its degradation: which microbes can metabolize these substrates, and the effects in the microbial community that overall, impact health. Additionally, structural differences in prebiotic fibers like agavins, may cause specific gastrointestinal (GI) adaptation and tolerance which is of great importance to promote their consumption and in determining an ideal amount or dose to further explore their impact.
In this study we propose a double-blind, placebo controlled, parallel groups, dose-escalation trial, where lean and obese subjects were assigned to either agavins or placebo group for a 5-week dose-escalation period. We aim to evaluate the evolution of GI tolerability and compared the records between lean and obese participants (Mexican adults), the impact in gut microbiota composition and activity through the determination of short-chain fatty acids and fecal metabolites, and metabolic status, all of this after a short period of time proposed to induce adaptation to agavins intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Healthy and obese participants randomized into agavins (prebiotic fiber) or placebo group received the corresponding dietary supplement simultaneously
| Arm | Type | Receives |
|---|---|---|
| Healthy-agavins | Experimental | Dietary Supplement: Agavins (prebiotic fiber)Agavins are branched neo-fructans and were supplemented for a 5-week dose-escalation period in lean participants |
| Healthy-placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin was used as placebo and supplemented for a 5-week dose-escalation period in lean participants |
| Obese-agavins | Experimental | Dietary Supplement: Agavins (prebiotic fiber)Agavins are branched neo-fructans that were supplemented for a 5-week dose-escalation period in obese participants |
| Obese-placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin was used as placebo and supplemented for a 5-week dose-escalation period in obese participants |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females
- Age 30 - 60 years
- BMI ≥ 30 kg/m2
- Stable body weight for at least 1 month prior to the study
Key exclusion criteria (25 listed)
- Type 1 and type 2 diabetes
- Hypothyroidism
- Currently following a weight loss diet or physical activity regime for the same purpose
- Weight loss >3 kg within 3 months before enrollment
- Use of prebiotics, probiotics, or dietary fiber supplements
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 |
|---|---|---|
| Agavins (prebiotic fiber)Also: Agave inulin (Preventy)Agavins contained in ready-to-use sachets were dissolved in water, and participants consumed the corresponding dose daily (2.5, 5.0, 7.0, 10 or 12 g) for 1 week, preferentially in the evening. Participants followed a 5-week dose-escalation intervention. | Dietary supplement | Healthy-agavins, Obese-agavins |
| PlaceboAlso: Maltodextrin (Globe 10 IP)Maltodextrin contained in ready-to-use sachets was dissolved in water, and participants consumed the corresponding dose daily (2.5, 5.0, 7.0, 10 or 12 g) for 1 week, preferentially in the evening. Participants followed a 5-week dose-escalation intervention. | Dietary supplement | Healthy-placebo, Obese-placebo |
Primary outcome
Gastrointestinal tolerability
Time frame: 0-5 weeks
Five gastrointestinal symptoms related to tolerability (flatulence, bloating, borborygmi, diarrhea, and abdominal pain) were assessed by a 10-cm Visual Analog Scale (VAS), guided by "no effect" (0 cm) , "moderate effect" (5 cm), and "worst effect possible" (10 cm). Participants rated their feelings 12 hours after taking their daily dose of dietary supplement, at the same time every day. All VAS were provided as printed material, one scale for each gastrointestinal symptom.
4 secondary outcomes
Appetite and satiety subjective assessment
Time frame: 0-5 weeks
Gut microbiota composition
Time frame: 5 weeks
SCFA production
Time frame: 5 weeks
Fecal metabolomics
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Background: PubMed 28832493Huazano-Garcia A, Shin H, Lopez MG. Modulation of Gut Microbiota of Overweight Mice by Agavins and Their Association with Body Weight Loss. Nutrients. 2017 Aug 23;9(9):821. doi: 10.3390/nu9090821.
- Background: PubMed 27490526Franco-Robles E, Lopez MG. Agavins Increase Neurotrophic Factors and Decrease Oxidative Stress in the Brains of High-Fat Diet-Induced Obese Mice. Molecules. 2016 Aug 2;21(8):998. doi: 10.3390/molecules21080998.
- Background: PubMed 26333285Huazano-Garcia A, Lopez MG. Agavins reverse the metabolic disorders in overweight mice through the increment of short chain fatty acids and hormones. Food Funct. 2015 Dec;6(12):3720-7. doi: 10.1039/c5fo00830a. Epub 2015 Sep 3.
- Background: PubMed 25367106Santiago-Garcia PA, Lopez MG. Agavins from Agave angustifolia and Agave potatorum affect food intake, body weight gain and satiety-related hormones (GLP-1 and ghrelin) in mice. Food Funct. 2014 Dec;5(12):3311-9. doi: 10.1039/c4fo00561a.
- Background: PubMed 25069021Garcia-Vieyra MI, Del Real A, Lopez MG. Agave fructans: their effect on mineral absorption and bone mineral content. J Med Food. 2014 Nov;17(11):1247-55. doi: 10.1089/jmf.2013.0137. Epub 2014 Jul 28.
- Background: PubMed 17711612Urias-Silvas JE, Cani PD, Delmee E, Neyrinck A, Lopez MG, Delzenne NM. Physiological effects of dietary fructans extracted from Agave tequilana Gto. and Dasylirion spp. Br J Nutr. 2008 Feb;99(2):254-61. doi: 10.1017/S0007114507795338. Epub 2007 Aug 22.
- Individual participant dataSharing planned: No. Results will be published in a peer-reviewed journal in the fields of dietetics and nutrition, with impact factor according to the Journal Citation Reports.
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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.
Mercedes G. López, PhD study director
Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional-UI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agavins (prebiotic fiber) in people with Obesity and Healthy, run by Centro De Investigación Y De Estudios Avanzados Del Instituto Politécnico Nacional-Unidad Irapuato at 2 sites 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 4 inclusion and 25 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: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal tolerability (time frame: 0-5 weeks). 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 NCT04555447, which also lists 6 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 18 Sep 2020.