Healthy Clinical Trial
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | September 7, 2019 |
Est. primary completion date | September 7, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Males and females - Age 30 - 60 years - BMI = 30 kg/m2 - Stable body weight for at least 1 month prior to the study Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional-Unidad Irapuato (CINVESTAV-UI) | Irapuato | Guanajuato |
Mexico | Centro de Estudios Cardiometabólicos S.C. (CESCAM) | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Centro De Investigación Y De Estudios Avanzados Del Instituto Politécnico Nacional-Unidad Irapuato | Centro de Estudios Cardiometabólicos S.C. (CESCAM), Inulina y Miel de Agave S.A. de C.V. (IMAG) |
Mexico,
Franco-Robles E, López 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). pii: E998. doi: 10.3390/molecules21080998. — View Citation
García-Vieyra MI, Del Real A, López 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. — View Citation
Huazano-García A, López 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. — View Citation
Huazano-García A, Shin H, López MG. Modulation of Gut Microbiota of Overweight Mice by Agavins and Their Association with Body Weight Loss. Nutrients. 2017 Aug 23;9(9). pii: E821. doi: 10.3390/nu9090821. — View Citation
Santiago-García PA, López 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. — View Citation
Urías-Silvas JE, Cani PD, Delmée E, Neyrinck A, López 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. Epub 2007 Aug 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Assessment of metabolic markers | Exploratory assessment of the concentration of clinically relevant metabolic markers, such as glucose, triglycerides, total cholesterol, HDL-C, LDL-C, etc., expressed in mg/dL was performed. | 0-5 weeks | |
Other | Body weight determination | Body weight (kg) was assessed by an 8-electrode bioelectrical impedance medical analyzer. | 0-5 weeks | |
Other | Fat mass, fat-free mass, body water, and skeletal muscle mass determination | Fat mass, fat-free mass, body water, and skeletal muscle mass percentages was assessed by an 8-electrode bioelectrical impedance medical analyzer. | 0-5 weeks | |
Primary | 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. | 0-5 weeks | |
Secondary | 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. | 0-5 weeks | |
Secondary | Gut microbiota composition | Gut microbiota composition was assessed by 16S rRNA sequencing | 5 weeks | |
Secondary | 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) | 5 weeks | |
Secondary | 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. | 5 weeks |
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