Effect of a Synergistic Food Basket on Metabolic Syndrome Risk

This study has been completed.
Sponsor:
Collaborator:
Antidiabetic Food Centre (Vinn Excellence Centre)
Information provided by (Responsible Party):
Juscelino Tovar, Lund University
ClinicalTrials.gov Identifier:
NCT01527253
First received: January 31, 2012
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Insulin Resistance
Other: Synergistic food basket

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of a Synergistic Food Basket on Markers of Metabolic Syndrome Risk in Healthy Mature Women

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Change from baseline in LDL cholesterol after each dietary period [ Time Frame: Week 0 and after 4 weeks (Start and End of the intervention arm) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in LDL-cholesterol/HDL-cholesterol after each dietary period [ Time Frame: Week 0 and after 4 weeks (Start and End of the intervention arm) ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma triglycerides after each dietary period [ Time Frame: Week 0 and after 4 weeks (Start and End of the intervention arm) ] [ Designated as safety issue: No ]
  • Change from baseline in fasting CRP after each dietary period [ Time Frame: Week 0 and after 4 weeks (Start and End of the intervention arm) ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma PYY after each dietary period [ Time Frame: Week 0 and after 4 weeks (Start and End of the intervention arm) ] [ Designated as safety issue: No ]
    Satiety signalling hormone PYY

  • Change from baseline in fasting plasma insulin after each dietary period [ Time Frame: Week 0 and after 4 weeks (Start and End of the intervention arm) ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose after each dietary period [ Time Frame: Week 0 and after 4 weeks (Start and End of the intervention arm) ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma PAI-1 after each dietary period [ Time Frame: Week 0 and after 4 weeks (Start and End of the intervention arm) ] [ Designated as safety issue: No ]
  • Change from baseline in BMI after each dietary period [ Time Frame: Week 0 and after 4 weeks (Start and End of the intervention arm) ] [ Designated as safety issue: No ]
    Body Mass Index

  • Change from baseline in blood pressure after each dietary period [ Time Frame: Week 0 and after 4 weeks (Start and End of the intervention arm) ] [ Designated as safety issue: No ]
  • Change from baseline in HOMA-IR after each dietary period [ Time Frame: Week 0 and after 4 weeks (Start and End of the intervention arm) ] [ Designated as safety issue: No ]
  • Change from baseline in waist circumference after each dietary period [ Time Frame: Week 0 and after 4 weeks (Start and End of the intervention arm) ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
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
Experimental: 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).
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527253

Locations
Sweden
Antidiabetic Food Centre, Chemical Centre. Lund University
Lund, Skane, Sweden, 221 00
Sponsors and Collaborators
Lund University
Antidiabetic Food Centre (Vinn Excellence Centre)
Investigators
Study Chair: Inger Björck, PhD Prof. Antidiabetic Food Centre, Lund University
Study Director: Juscelino Tovar, PhD Antidiabetic Food Centre, Lund University
Principal Investigator: Anne Nilsson, PhD Lund University
Principal Investigator: Maria Johansson, PhD Antidiabetic Food Centre, Lund University
  More Information

Additional Information:
Publications:
Responsible Party: Juscelino Tovar, Project Manager, Lund University
ClinicalTrials.gov Identifier: NCT01527253     History of Changes
Other Study ID Numbers: AFC-Food Basket
Study First Received: January 31, 2012
Last Updated: May 22, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Lund University:
Cardiometabolic risk
Metabolic syndrome
Prebiotics
Legumes
Wholegrain cereal
Functional diet
Low glycemic index diet

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Syndrome
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 02, 2014