Effect of a Synergistic Food Basket on Metabolic Syndrome Risk

NCT ID: NCT01527253

Last Updated: 2014-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-12-31

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.

Conditions

Metabolic Syndrome; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Active Diet

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)

Group Type: EXPERIMENTAL

Synergistic food basket

Intervention Type: 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

Control diet

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).

Group Type: EXPERIMENTAL

Synergistic food basket

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Anti-Diabetic Food Centre

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Juscelino Tovar

Project Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inger Björck, PhD Prof.

Role: STUDY_CHAIR

Antidiabetic Food Centre, Lund University

Juscelino Tovar, PhD

Role: STUDY_DIRECTOR

Antidiabetic Food Centre, Lund University

Anne Nilsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Maria Johansson, PhD

Role: PRINCIPAL_INVESTIGATOR

Antidiabetic Food Centre, Lund University

Locations

Antidiabetic Food Centre, Chemical Centre. Lund University

Lund, Skåne County, Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 17522615 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18356328 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18326603 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10197565 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24063257 (View on PubMed)

Other Identifiers

AFC-Food Basket

Identifier Type: -

Identifier Source: org_study_id