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Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects

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ClinicalTrials.gov Identifier: NCT03102853
Recruitment Status : Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
Lund University Hospital
Information provided by (Responsible Party):
LieseLotte Cloetens, 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.

Condition or disease Intervention/treatment Phase
Obesity Cardiovascular Risk Factor Diet Modification Other: Nordic diet Other: Control diet Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: Effects of a Healthy Nordic Diet on Abdominal Obesity, Body Weight Maintenance and Cardiometabolic Risk: a 2-year Randomised Controlled Study
Actual Study Start Date : August 15, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nordic diet Other: Nordic diet
Control diet Other: Control diet



Primary Outcome Measures :
  1. Change in sagittal abdominal diameter [ Time Frame: Change from baseline to month 6, 12, 18, 24 ]
  2. Change in body weight [ Time Frame: Change from baseline to month 6, 12, 18, 24 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]


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Ages Eligible for Study:   25 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102853


Locations
Sweden
Biomedical Nutrition, Lund University and Unit for Diabetesstudies, Lund University Hospital
Lund, Sweden, 221 00
Sponsors and Collaborators
Lund University
Lund University Hospital

Responsible Party: LieseLotte Cloetens, Principal Investigator, Lund University
ClinicalTrials.gov Identifier: NCT03102853     History of Changes
Other Study ID Numbers: NOVI377
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms