Effect of dietary fiber consumption on health

Not Applicable

• Conditions: Overweight individuals enrolled in a weight loss and cardiometabolic risk reduction program; Overweight

• Registration Number: RPCEC00000406
• Lead Sponsor: VIDARIUM-Centro de Investigación en Nutrición, Salud y Bienestar.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-16
• Study Completion: 2023-12-20
• Results First Posted: 2024-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 40

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/d

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intolerance or adverse effects to the consumption of soluble fiber (konjac glucomannan) during the intervention will be withdrawn from the study.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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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