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Effect of a Synergistic Food Basket on Metabolic Syndrome Risk

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01527253
Enrollment
52
Registered
2012-02-06
Start date
2011-09-30
Completion date
2012-12-31
Last updated
2014-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Metabolic Syndrome

Keywords

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

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.

Interventions

OTHERSynergistic 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

Sponsors

Anti-Diabetic Food Centre
CollaboratorOTHER
Lund University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change from baseline in LDL cholesterol after each dietary periodWeek 0 and after 4 weeks (Start and End of the intervention arm)

Secondary

MeasureTime frameDescription
Change from baseline in fasting plasma triglycerides after each dietary periodWeek 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting CRP after each dietary periodWeek 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma PYY after each dietary periodWeek 0 and after 4 weeks (Start and End of the intervention arm)Satiety signalling hormone PYY
Change from baseline in fasting plasma insulin after each dietary periodWeek 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma glucose after each dietary periodWeek 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in LDL-cholesterol/HDL-cholesterol after each dietary periodWeek 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in BMI after each dietary periodWeek 0 and after 4 weeks (Start and End of the intervention arm)Body Mass Index
Change from baseline in blood pressure after each dietary periodWeek 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in HOMA-IR after each dietary periodWeek 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in waist circumference after each dietary periodWeek 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma PAI-1 after each dietary periodWeek 0 and after 4 weeks (Start and End of the intervention arm)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026