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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community-1 | Other | Received control flour first and then Resistant starch type 4 (RS4) flour |
|
| Community-2 | Other | Received RS4 flour first and then control flour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RS4 enriched flour | Other | Wheat flour with 30% resistant starch (type-4) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in metabolic syndrome risk components | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in anthropometric outcomes | Body weight, body mass index, systolic and diastolic blood pressure, fat mass and fat-free mass | 26 weeks |
| Changes in blood lipid profile | total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides |
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Inclusion Criteria:
- Any individual aged 18-80 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moul Dey, PhD | South Dakota State University | Principal Investigator |
| Bonny Specker, PhD | South Dakota State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Dakota State University | Brookings | South Dakota | 57007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36337613 | Derived | 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. |
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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.
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Control flour | Other | Wheat flour without resistant starch (type-4) |
|
| 26 weeks |
| Changes in blood glucose indices | fasting blood glucose, postprandial blood glucose and Hemoglobin-A1C | 26 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |