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Completed

NCT Number: NCT01527253

Effect of a Synergistic Food Basket on Metabolic Syndrome Risk

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Antidiabetic Food Centre, Chemical Centre. Lund University

Lund, Skåne County, 221 00, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

    Satiety signalling hormone PYY

  5. 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)

  6. 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)

  7. 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)

  8. Change from baseline in BMI after each dietary period

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

    Body Mass Index

  9. 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)

  10. 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)

  11. 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)

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Anti-Diabetic Food Centre

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 6, 2012
Registry last updated
May 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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