Metabolic SyndromeNCT01887964
Effect of Resistant Starch (Type-4) on Metabolic Syndrome
A study testing RS4 enriched flour in people with Metabolic Syndrome, run by South Dakota State University at 1 site in United States.
Trial summary
Metabolic syndrome is a condition characterized by excess body weight, large waist circumference, high cholesterol and glucose in the blood, and hypertension. People with metabolic syndrome are at increased risk for heart diseases. Research shows benefits of regular fiber intake in metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- RS4 enriched flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Oct 2012
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any individual aged 18-80 years
Who cannot join
- Pregnant
- Lactating
- Requires special diets or dietary regimens
- On long term antibiotic therapy
- Diagnosed with gastrointestinal diseases (Irritable Bowel syndrome, Crohn's disease or Colitis)
- Immune compromised
- Have cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
South Dakota State University
Brookings, South Dakota, 57007
About this study
Official title: Dietary Fiber Intervention in Hutterite Population of South Dakota With and Without Signs of Metabolic Syndrome
Metabolic syndrome is a condition characterized by excess body weight, large waist circumference, high cholesterol and glucose in the blood, and hypertension. People with metabolic syndrome are at increased risk for heart diseases. Research shows benefits of regular fiber intake in metabolic syndrome. However, due to altered taste and texture of the high fiber foods, long term intake of fiber is a challenge for metabolic syndrome patients. This study is designed to find if blinded-substitution of regular wheat flour in domestic kitchen with wheat flour enriched by an adaptable type of fiber (resistant starch-4), minimizes metabolic syndrome symptoms. this special type of fiber is also obtained from wheat.
- Conditions
- Metabolic Syndrome
- Being tested
- RS4 enriched flour, Control flour
- Keywords
- Diabetes, Obesity, Cardiovascular disease, Metabolic syndrome
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS4 enriched flourOther
Wheat flour with 30% resistant starch (type-4)
Control flourOther
Wheat flour without resistant starch (type-4)
| Study group | Role | What they receive |
|---|---|---|
| Community-1 | Other | Received control flour first and then Resistant starch type 4 (RS4) flour Receives: Other: RS4 enriched flour; Other: Control flour |
| Community-2 | Other | Received RS4 flour first and then control flour Receives: Other: RS4 enriched flour; Other: Control flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in metabolic syndrome risk components
Measured: 26 weeks
Secondary outcomes (3)
Changes in anthropometric outcomes
Body weight, body mass index, systolic and diastolic blood pressure, fat mass and fat-free mass
Measured: 26 weeks
Changes in blood lipid profile
total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides
Measured: 26 weeks
Changes in blood glucose indices
fasting blood glucose, postprandial blood glucose and Hemoglobin-A1C
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moul Dey, South Dakota State University
- Investigators
- Moul Dey, PhD, Principal investigator, South Dakota State UniversityBonny Specker, PhD, Principal investigator, South Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887964
- Sponsor's protocol ID
- 1112012-CR
- Status last verified
- Sep 2021
- First submitted
- 20 Jun 2013
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant's identity will not be shared. This clinical trial is complete. All results were published as two research articles: PMCID: PMC4928084 and PMCID: PMC4048643. Raw sequence data were submitted to Sequence Read archive as referenced in the manuscript PMC4928084.
Publications
Dhakal S, Dey M. Resistant starch type-4 intake alters circulating bile acids in human subjects. Front Nutr. 2022 Oct 20;9:930414. doi: 10.3389/fnut.2022.930414. eCollection 2022.
PubMed 36337613
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Fiber Intervention in Hutterite Population of South Dakota With and Without Signs of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01887964
- Acronym / sponsor ID
- 1112012-CR
- Conditions
- Metabolic Syndrome
- Keywords
- Diabetes, Obesity, Cardiovascular disease, Metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- South Dakota State UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 27 Jun 2013 (estimated)
- 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 is a condition characterized by excess body weight, large waist circumference, high cholesterol and glucose in the blood, and hypertension. People with metabolic syndrome are at increased risk for heart diseases. Research shows benefits of regular fiber intake in metabolic syndrome. However, due to altered taste and texture of the high fiber foods, long term intake of fiber is a challenge for metabolic syndrome patients. This study is designed to find if blinded-substitution of regular wheat flour in domestic kitchen with wheat flour enriched by an adaptable type of fiber (resistant starch-4), minimizes metabolic syndrome symptoms. this special type of fiber is also obtained from wheat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community-1 | Other | Other: RS4 enriched flour, Other: Control flourReceived control flour first and then Resistant starch type 4 (RS4) flour |
| Community-2 | Other | Other: RS4 enriched flour, Other: Control flourReceived RS4 flour first and then control flour |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any individual aged 18-80 years
Key exclusion criteria (7 listed)
- Pregnant
- Lactating
- Requires special diets or dietary regimens
- On long term antibiotic therapy
- Diagnosed with gastrointestinal diseases (Irritable Bowel syndrome, Crohn's disease or Colitis)
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 |
|---|---|---|
| RS4 enriched flourWheat flour with 30% resistant starch (type-4) | Other | Community-1, Community-2 |
| Control flourWheat flour without resistant starch (type-4) | Other | Community-1, Community-2 |
Primary outcome
Changes in metabolic syndrome risk components
Time frame: 26 weeks
3 secondary outcomes
Changes in anthropometric outcomes
Time frame: 26 weeks
Changes in blood lipid profile
Time frame: 26 weeks
Changes in blood glucose indices
Time frame: 26 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 27 Sep 2021.
- Derived from this study: PubMed 36337613Dhakal S, Dey M. Resistant starch type-4 intake alters circulating bile acids in human subjects. Front Nutr. 2022 Oct 20;9:930414. doi: 10.3389/fnut.2022.930414. eCollection 2022.
- Individual participant dataSharing planned: No. Individual participant's identity will not be shared. This clinical trial is complete. All results were published as two research articles: PMCID: PMC4928084 and PMCID: PMC4048643. Raw sequence data were submitted to Sequence Read archive as referenced in the manuscript PMC4928084.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Moul Dey, PhD principal investigator
South Dakota State University
Bonny Specker, PhD principal investigator
South Dakota State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RS4 enriched flour in people with Metabolic Syndrome, run by South Dakota State University at 1 site in United States.
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 1 inclusion and 7 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 27 Sep 2021. 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 United States. 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. 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?
Changes in metabolic syndrome risk components (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01887964, which also lists 1 linked publication.
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 27 Sep 2021.