Cardiovascular Risk Factor, Diet Modification, Obesity
Conditions
Brief summary
This project will examine whether long-term consumption of healthy Nordic foods can maintain a healthy weight also after weight loss, and decrease abdominal fat accumulation and cardiometabolic risk. The study will be performed with the aim to achieve a substantial body weight loss in the first phase by prescribing a standardized low caloric dietary formula. The follow-up phase will be a body weight-maintenance period and the subjects will be randomised to a healthy Nordic diet group and a control diet group. During the study body weight will be monitored and other measurements will include insulin sensitivity, blood lipids and inflammation markers.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* age 25-67 years, BMI 30-40 kg/m2, waist circumference men \>102cm and women \> 88cm or sagittal abdominal diameter men \>22cm and women \>20cm, stable body weight
Exclusion criteria
* glucose \>7.0 mmol/l, B-Hb1aC \>48 mmol/L, triglycerides \>4 mmol/l, total cholesterol \>8 mmol/l, bloodpressure \>160/100 mmHg, chronic disease, gastro-intestinal disease, hyper-/hypothyroidism, alcohol abuse, cancer, gastric bypass operation, gluten allergy, lactose intolerance, pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in sagittal abdominal diameter | Change from baseline to month 6, 12, 18, 24 |
| Change in body weight | Change from baseline to month 6, 12, 18, 24 |
Secondary
| Measure | Time frame |
|---|---|
| Blood lipids | Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24 |
| Blood pressure | Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24 |
| Insulin sensitivity (HOMA-IR) | Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24 |
| Markers of inflammation and endothelial function | Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24 |
| Markers of kidney and liver function | Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24 |
| Body fat and body lean mass (BIA) | Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24 |
Countries
Sweden