Effect of Dietary Fiber on Metabolic Syndrome, Gastrointestinal Function, Mood and Sleep Quality in Obese People

NCT ID: NCT06626867

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-12-31

Brief Summary

Metabolic syndrome includes hypertension(high blood pressure), hyperglycemia(high blood suger), dyslipidemia(abnormal blood lipid level) and obesity. The more items that meet metabolic syndrome, the higher the risk of cardiovascular disease and diabetes, and the higher the combined mortality. At present, research reports point out that the occurrence of metabolic syndrome is related to age, obesity, lifestyle and genetics.

The lack of sleep may reduce the diversity of intestinal flora, and conversely, if the diversity of intestinal flora can be increased, the quality of sleep may be improved. Dietary fiber can improve intestinal microflora and related indexes of metabolic syndrome.

Although recent studies have demonstrated that dietary fiber will affect obesity, mood and sleep, different kinds of dietary fiber will affect different strains and pro-duce different effects. The effect of resistant starch on metabolic syndrome, mood and sleep of obese people is not very clear. Therefore, the objective of this intervention trial was to evaluate the effects of the intake of resistant starch on sleep, mood, changes in body composition and biomarkers in metabolic syndrome.

Conditions

Hypertension; Hyperglycemia; Dyslipidemia; Obesity; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

placebo

Ingest maltodextrin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The placebo was a colored capsule with 5 grams of maltodextrin, which is taken once a day.

dietary fiber

Ingest indigestible dextrin supplementation

Group Type: EXPERIMENTAL

Dietary Fiber Supplementation

Intervention Type: DIETARY_SUPPLEMENT

Each participant ingested either dietary fiber or placebo. The dietary fiber is indi-gestible dextrin (The WiseMan\'s Dining, KING CAR OTSUKA CO., Taipei, Taiwan). The dosage of contents in each package is 6 grams, 3 packs a day, with a total dose of 18 grams.

Interventions

Dietary Fiber Supplementation

Each participant ingested either dietary fiber or placebo. The dietary fiber is indi-gestible dextrin (The WiseMan\'s Dining, KING CAR OTSUKA CO., Taipei, Taiwan). The dosage of contents in each package is 6 grams, 3 packs a day, with a total dose of 18 grams.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The placebo was a colored capsule with 5 grams of maltodextrin, which is taken once a day.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Obese working popu-lation aged between 30 and 45;
• Body fat is more than 25% for male and more than 30% for female

Exclusion Criteria

• Taking any medicines;
• Menopausal women;
• Pregnant woman

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chien-Wen Hou

OTHER

Sponsor Role: lead

Responsible Party

Chien-Wen Hou

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Laboratory of Exercise Biochemistry, Department of Sports Sciences, University of Taipei

Taipei, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

2021006001

Identifier Type: -

Identifier Source: org_study_id