HypertensionNCT06626867
Effect of Dietary Fiber on Metabolic Syndrome, Gastrointestinal Function, Mood and Sleep Quality in Obese People
A study testing Dietary Fiber Supplementation in people with Hypertension and Hyperglycemia, run by Chien-Wen Hou at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Hyperglycemia, Dyslipidemia
- What is being tested?
- Dietary Fiber Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese working popu-lation aged between 30 and 45;
- Body fat is more than 25% for male and more than 30% for female
Who cannot join
- Taking any medicines;
- Menopausal women;
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Laboratory of Exercise Biochemistry, Department of Sports Sciences, University of Taipei
Taipei, Taiwan, 11153
About this study
Official title: Effect of Dietary Fiber on Metabolic Syndrome, Gastrointestinal Function, Mood and Sleep Quality
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
- Being tested
- Dietary Fiber Supplementation, Placebo
- Keywords
- prebiotic, POMS, PSQI, indigestible dextrin, dietary fiber
- Medical subject headings
- Hypertension, Hyperglycemia, Dyslipidemias, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Fiber SupplementationDietary 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.
PlaceboOther
The placebo was a colored capsule with 5 grams of maltodextrin, which is taken once a day.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Ingest maltodextrin Receives: Other: Placebo |
| dietary fiber | Experimental | Ingest indigestible dextrin supplementation Receives: Dietary Supplement: Dietary Fiber Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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:
- Tension
- Depression
- Anger
- Fatigue
- Confusion
- 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.
Measured: 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:
- Subjective sleep quality - An individual\'s perception of their sleep quality.
- Sleep latency - The amount of time it takes to fall asleep.
- Sleep duration - The total amount of sleep per night.
- Habitual sleep efficiency - The ratio of total sleep time to time spent in bed.
- 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).
- Use of sleep medication - The frequency and use of medication to help sleep.
- 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (2)
Blood pressure
Blood pressure will be measured from the non-dominant arm with a digital blood pressure monitor (Omron HEM-7121, Japan) in sitting position after at least 15 min of rest, including diastolic blood pressure and systolic blood pressure.
Measured: From enrollment to the end of treatment at 8 weeks
Anthropometrics
Body height and weight will be measured on a stadiometer (Takei Scientific In-struments, Tokyo, Japan) and digital scale (TANITA WB-110MA, Tokyo, Japan) to the nearest 0.1 cm and 0.1 kg without shoes and wearing light clothes. Waist circumference was measured at the midpoint between the iliac crest and the lowest rib margin, and hip circumference was assessed at the widest point around the buttocks. Based on the anthropometric metric measures, body mass index (BMI; kg/m2) and waist to hip ratio (WHR; waist/hip) were calculated.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Oct 2021
- Primary completion8 May 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chien-Wen Hou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chien-Wen Hou, University of Taipei
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626867
- Sponsor's protocol ID
- 2021006001
- Status last verified
- Oct 2024
- First submitted
- 1 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Fiber on Metabolic Syndrome, Gastrointestinal Function, Mood and Sleep Quality
- ClinicalTrials.gov ID
- NCT06626867
- Acronym / sponsor ID
- 2021006001
- Conditions
- Hypertension, Hyperglycemia, Dyslipidemia, Obesity, Metabolic Syndrome
- Keywords
- prebiotic, POMS, PSQI, indigestible dextrin, dietary fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Chien-Wen HouUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 8 May 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: PlaceboIngest maltodextrin |
| dietary fiber | Experimental | Dietary Supplement: Dietary Fiber SupplementationIngest indigestible dextrin supplementation |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obese working popu-lation aged between 30 and 45;
- Body fat is more than 25% for male and more than 30% for female
Key exclusion criteria (3 listed)
- Taking any medicines;
- Menopausal women;
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Fiber SupplementationEach 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 supplement | dietary fiber |
| PlaceboThe placebo was a colored capsule with 5 grams of maltodextrin, which is taken once a day. | Other | placebo |
Primary outcome
Body fat percentage
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Fasting glucose
Time frame: From enrollment to the end of treatment at 8 weeks
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).
Mood disturbance(Questionnaires)
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Pittsburgh Sleep Quality Index(Questionnaires)
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Biochemical Markers
Time frame: From enrollment to the end of treatment at 8 weeks
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
High sensitivity C-reactive protein
Time frame: From enrollment to the end of treatment at 8 weeks
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).
Total cholesterol
Time frame: From enrollment to the end of treatment at 8 weeks
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).
Triglyceride
Time frame: From enrollment to the end of treatment at 8 weeks
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).
2 secondary outcomes
Blood pressure
Time frame: From enrollment to the end of treatment at 8 weeks
Anthropometrics
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Fiber Supplementation in people with Hypertension and Hyperglycemia, run by Chien-Wen Hou at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body fat percentage (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.