An interventional study of VLCD-Active and Maintenance-Active in Weight Loss, Metabolism and Nutrition Disorder and Obesity, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Treatment
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.
275 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.
This study's enrollment of 110 is close to the median of 117 across 194 interventional studies indexed under Nutrition Disorders.
Browse Nutrition Disorders studies →University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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Exclusion Criteria (main:
Very low calorie diet, 600 kcal pr day for eight weeks.
Dietary Supplement: VLCD-Control
Very low calorie diet plus additional 25 g protein powder, 700 kcal pr day for eight weeks.
Dietary Supplement: VLCD-Active
12-week weight maintenance diets: Moderate protein weight maintenance diet (MP-WMD): Recommended healthy diet including 25 g beef daily. The diet is ad libitum and will be high in fibre (40 g/10 MJ) and whole grain (150 g/day) and allow inclusion of free/added sugar up to the recommended level (\<10E% sugar).
Other: Maintenance-Control
12-week weight maintenance diets: High protein weight maintenance diet (HP-WMD): The macronutrient distribution will be 25 energy percentage (E%) from protein, 45 E% from carbohydrate and 30 E% from fat. The diet will include 150 g beef as a daily source of protein, The diet is ad libitum and will be high in fibre (40 g/10 MJ) and whole grain (150 g/day) and allow inclusion of free/added sugar up to the recommended level (\<10E% sugar).
Other: Maintenance-Active
Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.
Also known as: High protein VLCD
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.
Also known as: High protein diet
Lighter life VLCD products
Also known as: Moderat protein VLCD
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.
Also known as: Moderate protein diet
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
Initial glucose metabolism
To investigate the effect of initial glucose metabolism on the response to high vs. moderate protein diet on weight maintenance.
Time frame: Up to week 21
Initial microbiota
Statistical investigation of the effect of initial microbiota assessed by fecal sample on weight change
Time frame: Up to week 21
Initial body composition
Statistical investigation of the effect of initial body composition assessed by DXA scan on weight change.
Time frame: Up to week 21
Physical activity and sleep
Physical activity and sleep patterns will be measured by an accelerometer (ActiGraph GT3X+) in the 7 days/8 nights
Time frame: Up to week 21
Perceived stress
Assessed by Perceived Stress Scale questionnaire
Time frame: Up to week 21
Life quality
Assessed by SF-36 questionnaire
Time frame: Up to week 21
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University of Copenhagen