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Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects

Effects of a Healthy Nordic Diet on Abdominal Obesity, Body Weight Maintenance and Cardiometabolic Risk: a 2-year Randomised Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03102853
Enrollment
80
Registered
2017-04-06
Start date
2016-08-15
Completion date
2019-12-31
Last updated
2020-05-12

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

Conditions

Cardiovascular Risk Factor, Diet Modification, Obesity

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

OTHERControl diet

Sponsors

Lund University Hospital
CollaboratorOTHER
Lund University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Eligibility

Sex/Gender
ALL
Age
25 Years to 67 Years
Healthy volunteers
Yes

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

MeasureTime frame
Change in sagittal abdominal diameterChange from baseline to month 6, 12, 18, 24
Change in body weightChange from baseline to month 6, 12, 18, 24

Secondary

MeasureTime frame
Blood lipidsBefore and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Blood pressureBefore 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 functionBefore 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 functionBefore 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

Outcome results

None listed

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