An interventional study of RS4 enriched flour and Control flour in Metabolic Syndrome, sponsored by South Dakota State University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-27.
Sponsored by South Dakota State University · Not applicable, Interventional, and Prevention
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.
2,011 studies on the registry are indexed under Metabolic Syndrome; 334 are open to participants now.
This study's enrollment of 86 is above the median of 60 across 1,494 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →South Dakota State University is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
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- Any individual aged 18-80 years
Exclusion Criteria:
Received control flour first and then Resistant starch type 4 (RS4) flour
Other: RS4 enriched flour · Other: Control flour
Received RS4 flour first and then control flour
Other: RS4 enriched flour · Other: Control flour
Wheat flour with 30% resistant starch (type-4)
Wheat flour without resistant starch (type-4)
Changes in metabolic syndrome risk components
Time frame: 26 weeks
Changes in anthropometric outcomes
Body weight, body mass index, systolic and diastolic blood pressure, fat mass and fat-free mass
Time frame: 26 weeks
Changes in blood lipid profile
total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides
Time frame: 26 weeks
Changes in blood glucose indices
fasting blood glucose, postprandial blood glucose and Hemoglobin-A1C
Time frame: 26 weeks
Plan to share: 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.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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South Dakota State University