Skip to main content
OpenTrials
Completed

NCT Number: NCT03102853

Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Cardiovascular Risk Factor Diet Modification Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biomedical Nutrition, Lund University and Unit for Diabetesstudies, Lund University Hospital

Lund, 221 00, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nordic diet

Other

Control diet

Other

Primary outcomes

  1. Change in sagittal abdominal diameter

    Time frame: Change from baseline to month 6, 12, 18, 24

  2. Change in body weight

    Time frame: Change from baseline to month 6, 12, 18, 24

Secondary outcomes

  1. Insulin sensitivity (HOMA-IR)

    Time frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24

  2. Body fat and body lean mass (BIA)

    Time frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24

  3. Blood lipids

    Time frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24

  4. Blood pressure

    Time frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24

  5. Markers of kidney and liver function

    Time frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24

  6. Markers of inflammation and endothelial function

    Time frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Lund University Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2017
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.