Effect of a Synergistic Food Basket on Metabolic Syndrome Risk

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527253
• Other study ID #: AFC-Food Basket
• Status: Completed
• Phase: N/A
• First received: January 31, 2012
• Last updated: May 22, 2014
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• Synergistic food basket
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

Locations

Country	Name	City	State
Sweden	Antidiabetic Food Centre, Chemical Centre. Lund University	Lund	Skane

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Anti-Diabetic Food Centre

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Liljeberg HG, Akerberg AK, Björck IM. Effect of the glycemic index and content of indigestible carbohydrates of cereal-based breakfast meals on glucose tolerance at lunch in healthy subjects. Am J Clin Nutr. 1999 Apr;69(4):647-55. — View Citation

Nilsson A, Ostman E, Preston T, Björck I. Effects of GI vs content of cereal fibre of the evening meal on glucose tolerance at a subsequent standardized breakfast. Eur J Clin Nutr. 2008 Jun;62(6):712-20. Epub 2007 May 23. — View Citation

Nilsson AC, Ostman EM, Granfeldt Y, Björck IM. Effect of cereal test breakfasts differing in glycemic index and content of indigestible carbohydrates on daylong glucose tolerance in healthy subjects. Am J Clin Nutr. 2008 Mar;87(3):645-54. — View Citation

Nilsson AC, Ostman EM, Holst JJ, Björck IM. Including indigestible carbohydrates in the evening meal of healthy subjects improves glucose tolerance, lowers inflammatory markers, and increases satiety after a subsequent standardized breakfast. J Nutr. 2008 Apr;138(4):732-9. — View Citation

Tovar J, Nilsson A, Johansson M, Björck I. Combining functional features of whole-grain barley and legumes for dietary reduction of cardiometabolic risk: a randomised cross-over intervention in mature women. Br J Nutr. 2014 Feb;111(4):706-14. doi: 10.1017 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in LDL cholesterol after each dietary period		Week 0 and after 4 weeks (Start and End of the intervention arm)	No
Secondary	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)	No
Secondary	Change from baseline in fasting plasma triglycerides after each dietary period		Week 0 and after 4 weeks (Start and End of the intervention arm)	No
Secondary	Change from baseline in fasting CRP after each dietary period		Week 0 and after 4 weeks (Start and End of the intervention arm)	No
Secondary	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)	No
Secondary	Change from baseline in fasting plasma insulin after each dietary period		Week 0 and after 4 weeks (Start and End of the intervention arm)	No
Secondary	Change from baseline in fasting plasma glucose after each dietary period		Week 0 and after 4 weeks (Start and End of the intervention arm)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Change from baseline in blood pressure after each dietary period		Week 0 and after 4 weeks (Start and End of the intervention arm)	No
Secondary	Change from baseline in HOMA-IR after each dietary period		Week 0 and after 4 weeks (Start and End of the intervention arm)	No
Secondary	Change from baseline in waist circumference after each dietary period		Week 0 and after 4 weeks (Start and End of the intervention arm)	No

External Links

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