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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diet Modification; Cardiovascular Risk Factor
• Intervention / Treatment: Other: Control diet; Other: Nordic diet

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 221 00
    • Biomedical Nutrition, Lund University and Unit for Diabetesstudies, Lund University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nordic diet	Other: Nordic diet
Other: Control diet	Other: Control diet

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: Lund University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2016
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: NOVI377

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No