Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects

NCT03102853 | Completed

• 1 other identifier: NOVI377
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Cardiovascular Risk Factor; Diet Modification

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (2)

Nordic diet

ACTIVE COMPARATOR

Other: Nordic diet

Control diet

OTHER

Other: Control diet

Interventions

Nordic diet OTHER

Nordic diet

Control diet OTHER

Control diet

Eligibility Criteria

• Age: 25 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead
• Lund University Hospital: collaborator

Study Sites (1)

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

Lund, 221 00, Sweden

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 6, 2017
• Study Start: August 15, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

SE (1)