Effect of a Synergistic Food Basket on Metabolic Syndrome Risk

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Insulin Resistance
• Interventions: Other: Synergistic food basket

• Registration Number: NCT01527253
• Lead Sponsor: Lund University

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-06
• Primary Completion: 2012-05
• Study Completion: 2012-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-22
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Diet	Synergistic food basket	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)
Control diet	Synergistic food basket	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 CRP 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)
Change from baseline in fasting plasma PYY after each dietary period	Week 0 and after 4 weeks (Start and End of the intervention arm)	Satiety signalling hormone PYY
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 BMI after each dietary period	Week 0 and after 4 weeks (Start and End of the intervention arm)	Body Mass Index
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 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 HOMA-IR 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)

Trial Locations

Locations (1)

Antidiabetic Food Centre, Chemical Centre. Lund University; 🇸🇪 Lund, Skane, Sweden