Revisions for Effect of dietary fiber consumption on health | Registro Público Cubano de Ensayos Clínicos

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Revision of 13 February 2023 - 12:18pm:

Effect of dietary fiber consumption on health

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

FiberHealth

Scientific title:

Effect of dietary fiber consumption on body composition, gut microbiota and biochemical markers associated with metabolic state in overweight people: a pilot study

Secondary indentifying numbers:

25-2021-C

Issuing authority of the secondary identifying numbers:

Ethics Committee in Human Research, CES University

Source(s) of monetary or material support:

VIDARIUM-Centro de Investigación en Nutrición, Salud y Bienestar, Grupo de investigación ICIF-Universidad del CES, Compañía de Galletas Noel S.A.S

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Katalina

Last name:

Munnoz-Durango

Medical Specialty :

Pharmaceutical chemistry, Diploma: Research and development of products to meet public health needs, PhD in Chemistry science

Affiliation:

VIDARIUM- Nutrition, Health and Wellness Research Center

Postal address:

Cl. 67 #52-20

City:

Medellin

Country:

Colombia

Zip Code:

050010

Telephone:

+57-3006531404

Email address:

kmunoz@serviciosnutresa.com

kmunos@gmail.com

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Colombia

Clinical sites:

Medellín-Antioquia, Clínica Las Américas-AUNA, Doctor Juan Pablo Polanco (Physician, Internist)

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

15/06/2022

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Overweight individuals enrolled in a weight loss and cardiometabolic risk reduction program

Health condition(s) code:

Overweight

Intervention(s):

Dietary fiber (experimental group): Sachets of 2g compound by 1g of konjac glucomannan (dietary fiber) + 1g of dehydrated fruit, dissolved in 200mL of water before every meal (breakfast, lunch, and dinner; 3g/day of glucomannans; 6g/day of product) during 3 months. Dehydrated fruit (control group): Sachets of 2g of dehydrated fruit powder dissolved in 200mL of water before every meal (breakfast, lunch, and dinner; 6g/day of product) during 3 months.

Intervention code:

Dietary Fiber

Amorphophallus konjac

Placebos

Dietary Supplements

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Weight (values expressed in kg measured with digital weighing scale). Measurement Time: At baseline and, 12 weeks.

Key secondary outcomes:

1- Body composition (Body fat (values expressed in g/cm2 measured with densimeter LUNAR Prodigy); lean mass (values expressed in g/cm2 measured with densimeter LUNAR Prodigy); bone mass (values expressed in g/cm2 measured with densimeter LUNAR Prodigy); bioimpedance (values expressed in % of fat measured with InBody770)). Measurement Time: At baseline and, 12 weeks. 2- Gut microbiome (gut microbiome composition (values expressed as abundance of 16S rRNA gene fragments obtained from sequencing the variable V4 region with Illumina MiSeq technology)). Measurement Time: At baseline and, 12 weeks. 3- Biochemical markers (Total cholesterol in plasma (values expressed in mg/dL determined by enzymatic assay of oxidized glucose; cholesterol LDL, HDL (values expressed in mg/dL determined by direct enzymatic method); triglycerides (values expressed in mg/dL determined by the enzymatic colorimetric test, Roche, Mannheim, Germany); glycemia (values expressed in mg/dL determined by enzymatic assay); fasting insulin (values expressed in µUI/mL measured by a chemo-luminescence immunoassay); glycosylated hemoglobin (values expressed in mmol/mol measured with HPLC, Premier Hb9210; Lab Care, UK); C-reactive protein (values expressed in mg/dL determined by immunoturbidimetric high-sensitivity assay, Roche Diagnostics Mannheim, Germany, Hitachi 902); IL-18 (values expressed in ng/mL measured by multianalyte immunoassay using xMAP from Luminex and reads obtained from multi analyzer Magpix, Luminex Corp., USA); Chemerin (values expressed in ng/mL measured by multianalyte immunoassay using xMAP from Luminex and reads obtained from multi analyzer Magpix, Luminex Corp., USA); LBP in plasma (values expressed in ng/mL measured by multianalyte immunoassay using xMAP from Luminex and reads obtained from multi analyzer Magpix, Luminex Corp., USA); oxysterols (values expressed in mg/dL measured with GC/MS); short fatty acids in plasma (values expressed in mg/dL measured with GC/MS); Peptides: AgRP/ART, adiponectin, leptin (values expressed in ng/mL measured by multianalyte immunoassay using xMAP from Luminex and reads obtained from multi analyzer Magpix, Luminex Corp., USA)). Measurement Time: At baseline and, 12 weeks. 4- Food consumption (values expressed in g recorded as 24-hour reminder format). Measurement Time: At baseline and 3, 6, and 12 weeks. 5- Blood pressure (values expressed in mm Hg measured with blood pressure monitor). Measurement Time: At baseline and, 12 weeks.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

20 years

Maximum age:

50 years

Inclusion criteria:

1. Volunteers 2. age ≥ 20 and ≤ 50 3. BMI ≥27.0 and <35 kg/m2 4. With at least one of the following conditions: 4.1 Abdominal circumference ≥88 cm in women and ≥102 cm in men 4.2 Blood pressure ≥130/85 mm Hg (stage 1: 130-139 or 80-89 mm Hg) 4.3 HDL <40mg/dL (men) or <50 mg/dL (women) 4.4 triglycerides >150mg/dL 4.5 and/or fasting glucose ≥100 mg/dL

Exclusion criteria:

1. Heart attack 2. Congestive heart failure 3. Stroke 4. Arrhythmia 5. Cancer 6. Chronic renal failure 7. Liver disorders 8. Insomnia 9. Duodenal ulcer 10. Gastritis 11. Malabsorption disorders (in general, diagnosed with gastrointestinal diseases) 12. Dysautonomia (positive tilt test) 13. Autoimmune and/or rheumatologic 14. Psychiatric disorders. 15. Those who have medically prescribed metformin, anti-inflammatories, steroids, hypnotic drugs, antibiotics, antiparasitics, or laxatives. Women who become pregnant during the study. 16. Individuals who show intolerance or adverse effects to the consumption of soluble fiber (konjac glucomannan) during the intervention will be withdrawn from the study. Their data, however, will be included in the group of poorest outcome (intention to treat).

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

N/A

Target sample size:

40

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Vanessa

Last Name:

Corrales Agudelo

Specialty:

Nutritionist. Master in Basic Biomedical Sciences, emphasis in Nutritional Biochemistry

Affiliation:

VIDARIUM-Nutrition, Health and Wellness Research Center

Postal Address:

Cl. 67 #52-20

City:

Medellin

Country:

Colombia

Zip Code:

050010

Telephone:

+57-3004369525

Email :

vcorrales@serviciosnutresa.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Katalina

Last Name:

Munnoz-Durango

Specialty:

Pharmaceutical chemistry, Diploma: Research and development of products to meet public health needs, PhD in Chemistry science

Affiliation:

VIDARIUM-Nutrition, Health and Wellness Research Center

Postal Address:

Cl. 67 #52-20

City:

Medellin

Country:

Colombia

Zip Code:

050010

Telephone:

+57-3006531404

Email :

kmunoz@serviciosnutresa.com

kmunos@gmail.com

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Institutional Committee of Ethics in Human Research Universidad CES

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

12/07/2021

Postal address of Ethic Committee :

Calle 10 A #22-04, Medellín Colombia

Email:

comiteeticahumanos@ces.edu.co

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/06/2023

Date of available results:

20/12/2023

Date of first publication:

30/06/2024

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000406

Date of Registration in Primary Registry:

16/05/2022

Record Verification Date:

2023/02/13

Next update date:

2024/02/13

Link to the spanish version:

Click here

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Effect of dietary fiber consumption on health

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