Effect of a Synergistic Food Basket on Metabolic Syndrome Risk

NCT01527253 | Completed

• 1 other identifier: AFC-Food Basket
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Insulin Resistance

Keywords

Cardiometabolic risk; Metabolic syndrome; Prebiotics; Legumes; Wholegrain cereal; Functional diet; Low glycemic index diet

Outcome Measures

Primary Outcomes (1)

• Change from baseline in LDL cholesterol after each dietary period

  Week 0 and after 4 weeks (Start and End of the intervention arm)

Secondary Outcomes (11)

• 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

  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)

Study Arms (2)

Active Diet

EXPERIMENTAL

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

Control diet

EXPERIMENTAL

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

Interventions

Synergistic food basket OTHER

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

Active Diet; Control diet

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI between 25 and 32 kg/m2

You may not qualify if:

• Fasting blood glucose \> 6.1 mmol/L
• Medication for high blood pressure and/or elevated blood cholesterol

Sponsors & Collaborators

• Lund University: lead
• Anti-Diabetic Food Centre: collaborator

Study Sites (1)

Antidiabetic Food Centre, Chemical Centre. Lund University

Lund, Skåne County, 221 00, Sweden

Location

Related Publications (5)

• Nilsson A, Ostman E, Preston T, Bjorck 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. doi: 10.1038/sj.ejcn.1602784. Epub 2007 May 23.

  PMID: 17522615 BACKGROUND

• Nilsson AC, Ostman EM, Holst JJ, Bjorck 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. doi: 10.1093/jn/138.4.732.

  PMID: 18356328 BACKGROUND

• Nilsson AC, Ostman EM, Granfeldt Y, Bjorck 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. doi: 10.1093/ajcn/87.3.645.

  PMID: 18326603 BACKGROUND

• Liljeberg HG, Akerberg AK, Bjorck 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. doi: 10.1093/ajcn/69.4.647.

  PMID: 10197565 BACKGROUND

• Tovar J, Nilsson A, Johansson M, Bjorck 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/S000711451300305X. Epub 2013 Sep 24.

  PMID: 24063257 RESULT

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Inger Björck, PhD Prof.

  Antidiabetic Food Centre, Lund University

  STUDY CHAIR

• Juscelino Tovar, PhD

  Antidiabetic Food Centre, Lund University

  STUDY DIRECTOR

• Anne Nilsson, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

• Maria Johansson, PhD

  Antidiabetic Food Centre, Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 6, 2012
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

SE (1)