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Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects

Primary Purpose

Obesity, Cardiovascular Risk Factor, Diet Modification

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Nordic diet

Control diet

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

25 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Nordic diet

Control diet

Arm Description

Outcomes

Primary Outcome Measures

Change in sagittal abdominal diameter

Change in body weight

Secondary Outcome Measures

Insulin sensitivity (HOMA-IR)

Body fat and body lean mass (BIA)

Blood lipids

Blood pressure

Markers of kidney and liver function

Markers of inflammation and endothelial function

Full Information

NCT ID

NCT03102853

First Posted

March 22, 2017

Last Updated

May 11, 2020

Sponsor

Lund University

Collaborators

Lund University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03102853

Brief Title

Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

August 15, 2016 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lund University

Collaborators

Lund University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Cardiovascular Risk Factor, Diet Modification

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nordic diet

Arm Type

Active Comparator

Arm Title

Control diet

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

Nordic diet

Intervention Type

Other

Intervention Name(s)

Control diet

Primary Outcome Measure Information:

Title

Change in sagittal abdominal diameter

Time Frame

Change from baseline to month 6, 12, 18, 24

Title

Change in body weight

Time Frame

Change from baseline to month 6, 12, 18, 24

Secondary Outcome Measure Information:

Title

Insulin sensitivity (HOMA-IR)

Time Frame