Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects

NCT ID: NCT03102853

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-15

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Obesity Cardiovascular Risk Factor Diet Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Study Groups

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Nordic diet

Group Type ACTIVE_COMPARATOR

Nordic diet

Intervention Type OTHER

Control diet

Group Type OTHER

Control diet

Intervention Type OTHER

Interventions

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Nordic diet

Intervention Type OTHER

Control diet

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lund University Hospital

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role lead

Responsible Party

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LieseLotte Cloetens

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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NOVI377

Identifier Type: -

Identifier Source: org_study_id

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