Clinical trial NCT03102853: Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects
Official title: Effects of a Healthy Nordic Diet on Abdominal Obesity, Body Weight Maintenance and Cardiometabolic Risk: a 2-year Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Risk Factor
Diet Modification
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Lund University Hospital
First posted: 2017-04-06
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in sagittal abdominal diameter
timeFrame: Change from baseline to month 6, 12, 18, 24
measure: Change in body weight
timeFrame: Change from baseline to month 6, 12, 18, 24
Secondary outcomes:
measure: Insulin sensitivity (HOMA-IR)
timeFrame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
measure: Body fat and body lean mass (BIA)
timeFrame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
measure: Blood lipids
timeFrame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
measure: Blood pressure
timeFrame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
measure: Markers of kidney and liver function
timeFrame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
measure: Markers of inflammation and endothelial function
timeFrame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Biomedical Nutrition, Lund University and Unit for Diabetesstudies, Lund University Hospital
Study officials:
References: