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

NCT06626867 | Completed

• 1 other identifier: 2021006001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

prebiotic; POMS; PSQI; indigestible dextrin; dietary fiber

Outcome Measures

Primary Outcomes (8)

• Body fat percentage

  Body fat percentage was estimated by dual-energy X-ray absorptiometry (DEXA; GE Lunar Prodigy 8743, Madison, WI, USA). The same experienced technician performed the analysis of the scan.

  From enrollment to the end of treatment at 8 weeks

• Fasting glucose

  Fasting blood samples were obtained at morning after the participants had 12 h of overnight fasting. To obtain plasma or serum, the blood samples with 5 ml collected into blood sampling tubes with or without ethylene diamine tetraacetic acid (EDTA), respectively, were centrifuged at 3000 rpm at 4 °C for 15 min and then stored at -80 °C until analysis. The plasma blood samples were assessed using fully automated analyz-er (AU5800, Beckman Coulter®, America). A set of standard samples will be collected and analysed on the same day, including fasting glucose(mmol/L).

  From enrollment to the end of treatment at 8 weeks

• Mood disturbance(Questionnaires)

  The Profile of Mood States, Revised (POMS-R) is an updated version of the original Profile of Mood States (POMS) questionnaire. It is a self-report tool used to assess a person\'s mood by measuring different dimensions of affective states, include: 1. Tension 2. Depression 3. Anger 4. Fatigue 5. Confusion 6. Vigor Total Mood Disturbance (TMD) score=(Sum of negative mood scores)-Vigor score. Higher scores in the negative mood dimensions (T, D, A, F, C) indicate greater mood disturbances, while a higher score in Vigor-Activity reflects a more positive mood. The TMD score reflects overall mood disturbance, with higher TMD indicating more severe mood issues. This scoring system helps provide a snapshot of a person\'s emotional state across various mood domains.

  From enrollment to the end of treatment at 8 weeks

• Pittsburgh Sleep Quality Index(Questionnaires)

  The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire used to assess sleep quality over a 1-month period. It includes 19 items grouped into seven components: 1. Subjective sleep quality - An individual\'s perception of their sleep quality. 2. Sleep latency - The amount of time it takes to fall asleep. 3. Sleep duration - The total amount of sleep per night. 4. Habitual sleep efficiency - The ratio of total sleep time to time spent in bed. 5. Sleep disturbances - The frequency of waking up due to various factors (e.g., needing to use the bathroom, feeling too hot/cold, or being disturbed by noise). 6. Use of sleep medication - The frequency and use of medication to help sleep. 7. Daytime dysfunction - Difficulties staying awake during the day or performing daily activities due to poor sleep. Each component is scored from 0 to 3, with a total score range of 0 to 21. A score above 5 indicates poor sleep quality.

  From enrollment to the end of treatment at 8 weeks

• Biochemical Markers

  Fasting blood samples were obtained at morning after the participants had 12 h of overnight fasting. To obtain plasma or serum, the blood samples with 5 ml collected into blood sampling tubes with or without ethylene diamine tetraacetic acid (EDTA), respectively, were centrifuged at 3000 rpm at 4 °C for 15 min and then stored at -80 °C until analysis. The plasma blood samples were assessed using fully automated analyz-er (AU5800, Beckman Coulter®, America). A set of standard samples will be collected and analysed on the same day, including fasting glucose, high sensitivity C-reactive protein (HsCRP), fasting insulin, total cholesterol, low density lipoprotein (LDL-C), high density lipoprotein (HDL-C) and triglyceride (TG). Insulin was measured by us-ing electrochemiluminescence immunoassay (ECLIA) (Cobas e801, Roche Diagnostics, Mannheim, Germany); glycated hemoglobin (HbA1c) was measured by using an ion exchange resin composed of hydrophilic polymer of methacrylate ester copolymer (H

  From enrollment to the end of treatment at 8 weeks

• High sensitivity C-reactive protein

  Fasting blood samples were obtained at morning after the participants had 12 h of overnight fasting. To obtain plasma or serum, the blood samples with 5 ml collected into blood sampling tubes with or without ethylene diamine tetraacetic acid (EDTA), respectively, were centrifuged at 3000 rpm at 4 °C for 15 min and then stored at -80 °C until analysis. The plasma blood samples were assessed using fully automated analyz-er (AU5800, Beckman Coulter®, America). A set of standard samples will be collected and analysed on the same day, including high sensitivity C-reactive protein (HsCRP)(mg/L).

  From enrollment to the end of treatment at 8 weeks

• Total cholesterol

  Fasting blood samples were obtained at morning after the participants had 12 h of overnight fasting. To obtain plasma or serum, the blood samples with 5 ml collected into blood sampling tubes with or without ethylene diamine tetraacetic acid (EDTA), respectively, were centrifuged at 3000 rpm at 4 °C for 15 min and then stored at -80 °C until analysis. The plasma blood samples were assessed using fully automated analyz-er (AU5800, Beckman Coulter®, America). A set of standard samples will be collected and analysed on the same day, including total cholesterol(mmol/L).

  From enrollment to the end of treatment at 8 weeks

• Triglyceride

  Fasting blood samples were obtained at morning after the participants had 12 h of overnight fasting. To obtain plasma or serum, the blood samples with 5 ml collected into blood sampling tubes with or without ethylene diamine tetraacetic acid (EDTA), respectively, were centrifuged at 3000 rpm at 4 °C for 15 min and then stored at -80 °C until analysis. The plasma blood samples were assessed using fully automated analyz-er (AU5800, Beckman Coulter®, America). A set of standard samples will be collected and analysed on the same day, including triglyceride (TG)(mmol/L).

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

• Blood pressure

  From enrollment to the end of treatment at 8 weeks

• Anthropometrics

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

Ingest maltodextrin

Other: Placebo

dietary fiber

EXPERIMENTAL

Ingest indigestible dextrin supplementation

Dietary Supplement: Dietary Fiber Supplementation

Interventions

Dietary Fiber Supplementation 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.

dietary fiber

Placebo OTHER

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

placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chien-Wen Hou: lead

Study Sites (1)

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

Taipei, Taiwan, 11153, Taiwan

Location

MeSH Terms

Conditions

Hypertension; Hyperglycemia; Dyslipidemias; Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: October 4, 2024
• Study Start: October 1, 2021
• Primary Completion: May 8, 2022
• Study Completion: December 31, 2022
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)