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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03102853
Date of registration:	22/03/2017
Prospective Registration:	No
Primary sponsor:	Lund University
Public title:	Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects
Scientific title:	Effects of a Healthy Nordic Diet on Abdominal Obesity, Body Weight Maintenance and Cardiometabolic Risk: a 2-year Randomised Controlled Study
Date of first enrolment:	August 15, 2016
Target sample size:	80
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03102853
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention.
Phase:	N/A

Countries of recruitment
Sweden

Contacts

Key inclusion & exclusion criteria

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

Age minimum: 25 Years
Age maximum: 67 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diet Modification

Cardiovascular Risk Factor

Obesity

Intervention(s)

Other: Control diet

Other: Nordic diet

Primary Outcome(s)

Change in body weight [Time Frame: Change from baseline to month 6, 12, 18, 24]

Change in sagittal abdominal diameter [Time Frame: Change from baseline to month 6, 12, 18, 24]

Secondary Outcome(s)

Blood lipids [Time Frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24]

Blood pressure [Time Frame: 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 [Time Frame: 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) [Time Frame: 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 [Time Frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24]

Insulin sensitivity (HOMA-IR) [Time Frame: Before and after body weight loss/maintenance: baseline (week -6), 0 (after 6-week weight loss period, month 6, 12, 18, 24]

Secondary ID(s)

NOVI377

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Lund University Hospital

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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