Metabolic Syndrome
Conditions
Keywords
Diabetes, Obesity, Cardiovascular disease, Metabolic syndrome
Brief 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. 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.
Interventions
OTHERRS4 enriched flour
Wheat flour with 30% resistant starch (type-4)
OTHERControl flour
Wheat flour without resistant starch (type-4)
Sponsors
South Dakota State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
\- Any individual aged 18-80 years
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in metabolic syndrome risk components | 26 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in anthropometric outcomes | 26 weeks | Body weight, body mass index, systolic and diastolic blood pressure, fat mass and fat-free mass |
| Changes in blood lipid profile | 26 weeks | total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides |
| Changes in blood glucose indices | 26 weeks | fasting blood glucose, postprandial blood glucose and Hemoglobin-A1C |
Countries
United States
Outcome results
None listed