Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects

Not Applicable

Completed

• Conditions: Diet Modification; Obesity; Cardiovascular Risk Factor
• Interventions: Other: Nordic diet; Other: Control diet

• Registration Number: NCT03102853
• Lead Sponsor: Lund University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-15
• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-06
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nordic diet	Nordic diet	-
Control diet	Control diet	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Biomedical Nutrition, Lund University and Unit for Diabetesstudies, Lund University Hospital; 🇸🇪 Lund, Sweden