Effect of a Synergistic Food Basket on Metabolic Syndrome Risk

Lund University

Status: Completed

Conditions: Insulin Resistance; Metabolic Syndrome

Treatments: Other: Synergistic food basket

Study type: Interventional

Funder types: Other

Identifiers

NCT01527253

AFC-Food Basket

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Active Diet

Experimental group

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)

Treatment:

Other: Synergistic food basket

Control diet

Experimental group

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).

Treatment:

Other: Synergistic food basket