An Optimized Programming of Healthy Children (APPROACH)
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|ClinicalTrials.gov Identifier: NCT01894139|
Recruitment Status : Active, not recruiting
First Posted : July 10, 2013
Last Update Posted : August 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Obesity Gestational Age and Weight Conditions Maternal Care for Excessive Fetal Growth Metabolic Disorders||Other: High-Protein/Low-GI Diet Other: Low-protein/High-GI Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||An Optimized Programming of Healthy Children (APPROACH) - The Most Favourable Dietary Protein:Carbohydrate Ratio During Pregnancy in the Context of New Nordic Diet|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2025|
Experimental: High-protein/Low-GI Diet
High-protein (25-28 E%), especially marine- and dairy-protein (8-10 E%) and low-GI (GI<55) ad libitum Diet in accordance with the principles of palatability and sustainability of the New Nordic Diet.
|Other: High-Protein/Low-GI Diet|
Active Comparator: Low-protein/High-GI Diet
Ad libitum diet based on the Danish National Guidelines (NNR) (protein 10-20 E%; no information on restricting glycaemic load (GI ~ 60)) and in accordance with the principles of palatability and sustainability of the New Nordic Diet.
|Other: Low-protein/High-GI Diet|
- Gestational weight gain [ Time Frame: Gestational week 14, 15, 17, 21, 25, 28, 36, 39 ]Changes in bodyweight, body composition (Magnetic Resonance Imaging) and measurements of body fat by means of skinfold thickness and mid-upper arm circumference.
- Growth and development of fetus and child [ Time Frame: Gestational week 11+2, 14+0, 28, 32, 36 and month 0, 6, 18, 36 and year 5, 9 ]Fetus: Nuchal Translucency Scan (once gw 11+3 - 14+0) and ultrasound scan (gw 28, 32, 36); child: Height, weight, body composition (Bioimpedance (month 6,18)and Dual-energy X-ray absorptiometry, DXA (month 0, 36, year 5, 9)), skin fold thickness and mid-upper arm circumference, IGF-1.
- Fetal programming of obesity and metabolic disorders [ Time Frame: Month 0, 6,18, 36 and year 5, 9 ]Fasting blod samples (month 0 from umbilical cord), not at 6 months; dietary intake, physical activity, growth and development
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): NCT01894139
|Copenhagen University Hospital at Herlev (EFFECT)|
|Herlev, Denmark, 2730|
|Principal Investigator:||Arne V Astrup, Professor||Copenhagen University Hospital at Herlev (EFFECT)|