WP 3: Dietary intervention with supermarket model

Aim:

Execution of a 6 month, randomised, controlled dietary intervention trial of the NND vs. the Average Danish Diet (ADD) in younger adults, using the "supermarket model" in which the subjects receive all foods free of charge in order to achieve optimal dietary adherence. Approximately 250 young, Caucasian adults (18-50 y) with central obesity, of whom at least 2/3 also have 1 or more components of the metabolic syndrome, will be screened. The number of subjects screened should allow for 206 subjects to be randomised. The study is powered to detect relevant differences in body weight change between the two diets. Primary outcomes are changes in body weight (kg), body fat percentage (assessed by DXA), dietary compliance, drop-out rate and risk factors for type 2 diabetes and cardiovascular disease.

The secondary outcome measures will be the number of subjects losing more than 5% or more than 10% of initial body weight, changes in abdominal fat mass (estimated from DXA, waist circumference and sagittal diameter), fasting levels of appetite and satiety hormones. Changes in the fecal content of energy, calcium and fat are also secondary outcome measures.

In addition, samples for possible future assessment of genetic variation (SNP-analyses or direct gene sequencing), fatty acid composition of abdominal fat tissue and transcriptional expression in abdominal fat cells, will be collected and stored.

 

Milestones:

• Obtain approval from the local Ethics Committee.
• Recruitment & screening of subjects.
• Reconstruction of supermarket
• Establishment of computer programme and food database.
• Obtain sponsorship of foods (50 % of costs is in the budget).
• Pilot study of supermarket.
• Standardisation of the dietary instruction.
• Planning the anthropometric measurements.
• Planning the biochemical analyses.
• Randomisation of subjects.
• Six months dietary intervention.
• Interim analysis.
• Twelve month follow-up.
• Analysing the biological samples.

In addition, 4 sub-studies (WP 3A-D) are anchored in this intervention study and take advantage of the controlled design. These examine subsets of the participants before and after the intervention.