Effect of a Synergistic Food Basket on Metabolic Syndrome Risk

Study Overview
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Brief Summary
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The study evaluates the effect of a diet combining two different functional concepts on markers associated to cardiometabolic risk. The functional concepts are selected on the basis of their reported ability to influence the inflammatory tonus. It is hypothesized that the medium-term consumption of a diet combining low GI-prebiotic foods may positively influence various biomarkers associated with the risk for developing metabolic syndrome and cardiometabolic disease. Also, the combination of functional mechanisms are expected to result in synergistic effects.

Detailed Description
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The intervention is carried out in healthy women following a randomized crossover design in which an active (functional) diet is compared with a control diet formulated in agreement with the Nordic Dietary Recommendations but lacking the functional ingredients of the active regime. The active diet supplies important daily amounts of dried legumes and wholegrain cereal products. Each dietary treatment is applied for 4 weeks separated by a 4-6 week washout period. Subjects are encouraged to maintain a stable body weight under the whole trial.

Official Title
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Effects of a Synergistic Food Basket on Markers of Metabolic Syndrome Risk in Healthy Mature Women

Conditions
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Metabolic Syndrome, Insulin Resistance

Intervention / Treatment
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* Other: Synergistic food basket


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI between 25 and 32 kg/m2 Exclusion Criteria: Fasting blood glucose > 6.1 mmol/L Medication for high blood pressure and/or elevated blood cholesterol

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Diet<br>Subjects eat a diet designed according to the Nordic Dietary Recommendations containing important amounts of specific legume and cereal ingredients that provide substrates for the intestinal microflora (prebiotics) | Other: Synergistic food basket<br>* A low glycemic index diet enriched in dried legumes and wholegrain cereals is compared with a control regime lacking these functional ingredients for their ability to ameliorate different markers associated with the risk for developing cardiometabolic disease<br>|
| Experimental: Control diet<br>Subjects eat a diet designed according to the Nordic Dietary Recommendations but lacks the specific legume and cereal ingredients that provide substrates for the intestinal microflora (prebiotics). | Other: Synergistic food basket<br>* A low glycemic index diet enriched in dried legumes and wholegrain cereals is compared with a control regime lacking these functional ingredients for their ability to ameliorate different markers associated with the risk for developing cardiometabolic disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in LDL cholesterol after each dietary period |  | Week 0 and after 4 weeks (Start and End of the intervention arm) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in LDL-cholesterol/HDL-cholesterol after each dietary period |  | Week 0 and after 4 weeks (Start and End of the intervention arm) | 
| Change from baseline in fasting plasma triglycerides after each dietary period |  | Week 0 and after 4 weeks (Start and End of the intervention arm) | 
| Change from baseline in fasting CRP after each dietary period |  | Week 0 and after 4 weeks (Start and End of the intervention arm) | 
| Change from baseline in fasting plasma PYY after each dietary period | Satiety signalling hormone PYY | Week 0 and after 4 weeks (Start and End of the intervention arm) | 
| Change from baseline in fasting plasma insulin after each dietary period |  | Week 0 and after 4 weeks (Start and End of the intervention arm) | 
| Change from baseline in fasting plasma glucose after each dietary period |  | Week 0 and after 4 weeks (Start and End of the intervention arm) | 
| Change from baseline in fasting plasma PAI-1 after each dietary period |  | Week 0 and after 4 weeks (Start and End of the intervention arm) | 
| Change from baseline in BMI after each dietary period | Body Mass Index | Week 0 and after 4 weeks (Start and End of the intervention arm) | 
| Change from baseline in blood pressure after each dietary period |  | Week 0 and after 4 weeks (Start and End of the intervention arm) | 
| Change from baseline in HOMA-IR after each dietary period |  | Week 0 and after 4 weeks (Start and End of the intervention arm) | 
| Change from baseline in waist circumference after each dietary period |  | Week 0 and after 4 weeks (Start and End of the intervention arm) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiometabolic risk, Metabolic syndrome, Prebiotics, Legumes, Wholegrain cereal, Functional diet, Low glycemic index diet