Gastrointestinal Tolerability to Agavins and Impact on Host-gut Microbiota-metabolism Interactions Modulation

NCT04555447 | Completed DMC

• 1 other identifier: CINVESTAV-IRA-BYB-171018
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Obesity; Healthy

Keywords

Prebiotics; Agavins; Gastrointestinal tolerability; Obesity; Gut microbiota; SCFA; Fecal metabolites; Agave dietary fiber

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Appetite and satiety subjective assessment

  0-5 weeks

• Gut microbiota composition

  5 weeks

• SCFA production

  5 weeks

• Fecal metabolomics

  5 weeks

Other Outcomes (3)

• Assessment of metabolic markers

  0-5 weeks

• Body weight determination

  0-5 weeks

• Fat mass, fat-free mass, body water, and skeletal muscle mass determination

  0-5 weeks

Study Arms (4)

Healthy-agavins

EXPERIMENTAL

Agavins are branched neo-fructans and were supplemented for a 5-week dose-escalation period in lean participants

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

Dietary Supplement: Placebo

Obese-agavins

EXPERIMENTAL

Agavins are branched neo-fructans that were supplemented for a 5-week dose-escalation period in obese participants

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

Dietary Supplement: Placebo

Interventions

Agavins (prebiotic fiber) DIETARY_SUPPLEMENT

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.

Also known as: Agave inulin (Preventy)

Healthy-agavins; Obese-agavins

Placebo DIETARY_SUPPLEMENT

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.

Also known as: Maltodextrin (Globe 10 IP)

Healthy-placebo; Obese-placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females
• Age 30 - 60 years
• BMI ≥ 30 kg/m2
• Stable body weight for at least 1 month prior to the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro De Investigación Y De Estudios Avanzados Del Instituto Politécnico Nacional-Unidad Irapuato: lead
• Centro de Estudios Cardiometabólicos S.C. (CESCAM): collaborator
• Inulina y Miel de Agave S.A. de C.V. (IMAG): collaborator

Study Sites (2)

Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional-Unidad Irapuato (CINVESTAV-UI)

Irapuato, Guanajuato, 36824, Mexico

Location

Centro de Estudios Cardiometabólicos S.C. (CESCAM)

Mexico City, 07760, Mexico

Location

Related Publications (6)

• 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.

  PMID: 28832493 BACKGROUND

• Franco-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.

  PMID: 27490526 BACKGROUND

• Huazano-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.

  PMID: 26333285 BACKGROUND

• Santiago-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.

  PMID: 25367106 BACKGROUND

• Garcia-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.

  PMID: 25069021 BACKGROUND

• Urias-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.

  PMID: 17711612 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mercedes G. López, PhD

  Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional-UI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A research assistant not involved in the study was responsible for the generation of each participant's code, and for providing codified bags with ready-to-use sachets of each dietary supplement with the corresponding dose. The clinical trial coordinator enrolled participants, and investigators and participants were blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Healthy and obese participants randomized into agavins (prebiotic fiber) or placebo group received the corresponding dietary supplement simultaneously

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 18, 2020
• Study Start: March 22, 2019
• Primary Completion: September 7, 2019
• Study Completion: September 7, 2019
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)