The study will be conducted as a parallel randomized controlled intervention trial, initiated by eight weeks rapid weight loss with one of two VLCDs, one week of reintroducing regular foods, and 12 weeks with one of two different ad libitum diets; in total 21 weeks. The study will be blinded for the statistician. Due to obvious different dietary intakes in the two diets, subjects cannot be blinded and neither the study personnel. As the study includes different dietary recommendations the registered clinical dietician advising the subjects cannot be blinded either. In total 110 overweight and obese volunteers will be included.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.
Weight loss maintenance diet with high protein and low glycemic index and load, high in fiber and whole grain, daily including 150 g minced beef.
Lighter life VLCD products
Weight loss maintenance diet with moderate protein and low glycemic index and load, high in fiber and whole grain, daily including 25 g minced beef.
University of Copenhagen
Frederiksberg, DK, Denmark
Body weight
The subjects will be instructed to stand in the middle of the platform of the scale with a straight neck and eyes looking straight ahead, whilst distributing their weight evenly on both feet. Two measurements are made when the scale has stabilized and both results are noted to the nearest 0.1 kg. The average of the two measurements is used in further analysis.
Time frame: up to week 21
Body composition
Body composition will be assessed by DXA as whole body scan
Time frame: up to week 21
Glucose metabolism
Measurements of fasting glucose, insulin, HbA1c
Time frame: up to week 21
Inflammation
Measurements of fasting CRP, plasma lipids
Time frame: Up to week 21
Fecal samples
Measurement of microbiota (bacteria strains present in feces) and metabolomics markers
Time frame: Up to week 21
Resting metabolic rate
Resting metabolic rate will be measured by indirect calorimetry, using a ventilated hood system as described by the manufacture
Time frame: Up to week 21
Endocrine disruptors
Measurement of fasting T3 and T4
Time frame: Up to week 21
Height
The participant will be instructed to remove shoes and asked to stand erect with their back to the wall-mounted stadiometer, with the back of their head, back, and buttocks touching the stadiometer. The participant will be further instructed to look straight ahead and keep arms relaxed and hanging loosely alongside their body and to inhale deeply. The reading on the stadiometer will be performed before the participant exhales. Two measurements are made and both results are recorded in centimeters to the nearest 0.5 of a centimeter. The average of the two measurements is used in further analysis.
Time frame: Week 0
Waist circumference
The measurement of waist circumference will be performed in a fasting condition with an empty bladder. The measure is done with a with a no-elastic tape measure mid-way between the lower rib and iliac crest (top of the hip bone) at the end of expiration with the participant in a standing position with their weight distributed evenly on both feet. Two measurements are made and both results are noted to the nearest 0.5 cm and the average of the two measurements is used in further analysis.
Time frame: Up to week 21
Hip circumference
The measurement of hip circumference will be measured in a fasting condition with an empty bladder. The measure is done with a tape measure at the widest point between the hips and buttocks observed from the front at the end of expiration with the participant in a standing position with their weight distributed evenly on both feet. Two measurements are made and both results are noted to the nearest 0.5 cm and the average of the two measurements is used in further analysis.
Time frame: Up to week 21
Blood pressure
Systolic and diastolic blood pressure will be measured using a validated automatic device with an appropriate arm cuff after 5-10 min rest in a resting position
Time frame: Up to week 21
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