Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102853
• Other study ID #: NOVI377
• Status: Completed
• Phase: N/A
• Start date: August 15, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 67 Years

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Diet Modification
• Obesity

Intervention

Other:
• Nordic diet

• Control diet

Locations

Country	Name	City	State
Sweden	Biomedical Nutrition, Lund University and Unit for Diabetesstudies, Lund University Hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Lund University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sagittal abdominal diameter		Change from baseline to month 6, 12, 18, 24
Primary	Change in body weight		Change from baseline to month 6, 12, 18, 24
Secondary	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
Secondary	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
Secondary	Blood lipids		Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Secondary	Blood pressure		Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24
Secondary	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
Secondary	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