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Effect of a Synergistic Food Basket on Metabolic Syndrome Risk

Primary Purpose

Metabolic Syndrome, Insulin Resistance

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Synergistic food basket

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Cardiometabolic risk, Metabolic syndrome, Prebiotics, Legumes, Wholegrain cereal, Functional diet, Low glycemic index diet

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Antidiabetic Food Centre, Chemical Centre. Lund University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Active Diet

Control diet

Arm Description

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)

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).

Outcomes

Primary Outcome Measures

Change from baseline in LDL cholesterol after each dietary period

Secondary Outcome Measures

Change from baseline in LDL-cholesterol/HDL-cholesterol after each dietary period

Change from baseline in fasting plasma triglycerides after each dietary period

Change from baseline in fasting CRP after each dietary period

Change from baseline in fasting plasma PYY after each dietary period

Satiety signalling hormone PYY

Change from baseline in fasting plasma insulin after each dietary period

Change from baseline in fasting plasma glucose after each dietary period

Change from baseline in fasting plasma PAI-1 after each dietary period

Change from baseline in BMI after each dietary period

Body Mass Index

Change from baseline in blood pressure after each dietary period

Change from baseline in HOMA-IR after each dietary period

Change from baseline in waist circumference after each dietary period

Full Information

NCT ID

NCT01527253

First Posted

January 31, 2012

Last Updated

May 22, 2014

Sponsor

Lund University

Collaborators

Anti-Diabetic Food Centre

1. Study Identification

Unique Protocol Identification Number

NCT01527253

Brief Title

Effect of a Synergistic Food Basket on Metabolic Syndrome Risk

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lund University

Collaborators

Anti-Diabetic Food Centre

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome, Insulin Resistance

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Diet

Arm Type

Experimental

Arm Description

Arm Title

Control diet

Arm Type

Experimental

Arm Description

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).

Intervention Type

Other

Intervention Name(s)

Synergistic food basket

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in LDL cholesterol after each dietary period

Time Frame