Evaluation of a Supplement of Agave Tequilana Weber Azul vs Psyllium Plantago in Patients With Functional Constipation

NCT04716868 | Unknown DMC

• 1 other identifier: GAS-1107-13/15-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Constipation is one of the gastrointestinal disorders MOST frequent That Affects around 20% of the western population, being more frequent in the female gender (M1.5: H1). Constipation can be primary, When causes constipation associated With (medication, mechanical obstruction, spinal cord injury, etc.) and secondary. There are multiple therapeutic options for the management of constipation, changes in lifestyle Including, the intake of fiber, laxatives and pharmacological treatment and in selected cases (colonic inertia) surgery. The first option in the therapeutic management for Patients With constipation are changes in lifestyle, Among Which is the type of diet (increase in fiber intake, Which Has Been Associated With an improvement in the fecal matter and the evacuation frequency), liquid intake and exercise. Aim: To Evaluate the efficacy of the blue agave fructans Tequilana Weber in Patients With functional constipation Methods: This is a prospective, randomized, controlled and single blind study to determine the phase III efficacy of the blue agave fructans Tequilana Weber intake in subjects with functional constipation. In order to Achieve so, it is planned to include over 18 years of Patients age Fulfill the WHO as well as inclusion criteria The Rome III criteria for functional constipation. Statistical analysis plan: The data obtained will be analyzed with SPSS version 24. For continuous variables the results are presented in mean ± standard deviation when the variables are normally distributed or medians and percentiles otherwise and as frequency and percentages when they were categorical. For basal and subsequent comparison to the intra intervention groups, Student's t-test for paired samples (variables with normal distribution) or the Mann-Whitney U (variables without normal distribution) is used in the case of continuous variables and X2 or the McNemar test in the case of categorical variables. For comparison between groups ANOVA (variables with normal distribution) or Kruskal-Wallis (non-normal distribution variables) used for continuous variables and the same percentage of change obtained when the variables are continuous. Also an analysis of covariance (ANCOVA) was performed to control variables that might have an effect on the response variables.

Conditions

Functional Constipation

Keywords

Functional constipation; Agave tequilana Weber var. Azul; Psyllium plantago; Microbiota

Outcome Measures

Primary Outcomes (1)

• An increase of more than one complete evacuation from basal spontaneous from baseline at the end of active

  Effect of supplementation of fructans Tequilana Weber blue agave in increasing at least one complete evacuation from basal spontaneous. Spontaneous evacuation It is defined as an evacuation in the absence of use of laxatives, suppositories or enemas and complete evacuation is defined as spontaneous evacuation to that sensation of incomplete emptying of the rectal ampulla.

  15 days

Secondary Outcomes (5)

• Change in the classification of Bristol

  15 days

• Effect of supplementation of fructan Weber blue agave Tequilana in the frequency of bowel movements

  15 days

• Evaluate the impact of the concentration of short-chain fatty acid, particularly butyrate, in the feces of subjects before and after addition of fructans Tequilana Weber blue agave.

  8 weeks

• IV. Evaluate the impact of supplementation fructans Weber blue agave Tequilana the microbiota

  8 weeks

• V. To evaluate the impact of serum glucose concentration and HbA1c fasting serum of subjects before and after addition of fructans Tequilana Weber blue agave

  8 weeks

Study Arms (4)

Agave Fructans 5 g

EXPERIMENTAL

Agave tequilana Weber blue variety 5 g once a day for 8 week.

Dietary Supplement: Agave Fructans 5 g

Agave Fructans 10 g

EXPERIMENTAL

Agave tequilana Weber blue variety 10 gf once a day for 8 week.

Dietary Supplement: Agave Fructans 10 g

Maltodextrin 10 g + Agave Fructans 5 g

EXPERIMENTAL

Maltodextrin 10 g + Agave tequilana Weber blue variety 5 g once a day for 8 week.

Dietary Supplement: Agave Fructans 5 g + Maltodextrin 10 g

Psyllium plantago 15 g

ACTIVE COMPARATOR

Psyllium plantago 15 g once a day for 8 week.

Dietary Supplement: Psyllium plantago

Interventions

Agave Fructans 5 g DIETARY_SUPPLEMENT

Agave tequilana Weber blue variety 5 g once a day for 8 weeks

Also known as: Agave fructans

Agave Fructans 5 g

Agave Fructans 10 g DIETARY_SUPPLEMENT

Agave tequilana Weber blue variety 10 g once a day for 8 weeks

Also known as: Agave fructans

Agave Fructans 10 g

Agave Fructans 5 g + Maltodextrin 10 g DIETARY_SUPPLEMENT

Maltodextrin 10 g + Agave tequilana Weber blue variety 5 g once a day for 8 weeks

Also known as: Agave fructans

Maltodextrin 10 g + Agave Fructans 5 g

Psyllium plantago DIETARY_SUPPLEMENT

Psyllium plantago 15 g once a day for 8 weeks

Psyllium plantago 15 g

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old.
• functional constipation ROME III criteria as
• Subjects ≥55 years with recent colonoscopy (\<3 years)

You may not qualify if:

• Taking supplements of fiber in the last 2 months
• Stimulant laxatives consumption chronically (Senna, Bisacodyl)
• decompensated comorbidities (example: uncontrolled diabetes mellitus HbA1c\> 9%, decompensated Organ failure, decompensated hypertension (untreated or TA\> 160 mmHg systolic and 95 mmHg diastolic)
• Using digital maneuvers or enemas to achieve evacuation
• Personal history of active or previous cancer
• abdominal surgery (except appendectomy, cholecystectomy, hysterectomy)
• Presence of alarm data in the last 6 months (trans-rectal bleeding, unexplained weight loss, abdominal pain)
• Use of drugs known promote constipation (opioid derivatives, calcium channel blockers, anticholinergics tricyclic antidepressants type)
• Prostration (immobility or poor mobility)
• Diseases such as untreated hypothyroidism with hormone replacement, and diseases associated with hypercalcemia that promote constipation
• Other causes of secondary constipation
• Meet criteria for constipation predominant irritable bowel
• Pregnancy.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

National Institute of Medical Sciences and Nutrition Salvador Zubiran

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (40)

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Related Links

• Book
• NOM-002-SAGARPA-2016
• Abstract
• Article
• Article

MeSH Terms

Interventions

maltodextrin

Study Officials

• Enrique Coss-Adame

  National Institute of Medical Sciences and Nutrition, Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrique Coss-Adame

CONTACT

+525554870900; enriquecossmd@gmail.com

Maria F Garcia-Cedillo

CONTACT

+525554870900; fernandagace1189@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Powder is flavored in order to mask at minimum the differences between type of fibers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology

Model Details: a prospective, randomized, controlled and single blind study to determine the efficacy of the blue agave Tequilana Weber fructans intake in subjects with functional constipation.

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: January 20, 2021
• Study Start: July 18, 2019
• Primary Completion: June 18, 2021
• Study Completion: August 18, 2021
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)