Effect of dietary fiber consumption on health

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000406

Enrollment

Registered

2022-05-16

Start date

2023-02-02

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 di

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.

Dietary Fiber

Amorphophallus konjac

Placebos

Dietary Supplements

Eligibility

Sex/Gender

All

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Volunteers 2. age = 20 and = 50 3. BMI =27.0 and 150mg/dL 4.5 and/or fasting glucose =100 mg/dL

Exclusion criteria

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or adverse effects to the consumption of soluble fiber (konjac glucomannan) during the intervention will be withdrawn from the study.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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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: AgR	—

Measure

Time frame

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: AgR

—

Countries

Colombia

Contacts

Public ContactVanessa Corrales Agudelo

VIDARIUM-Nutrition, Health and Wellness Research Center

vcorrales@serviciosnutresa.com

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026