Metabolism and Nutrition Disorder, Obesity, Weight Loss
Conditions
Keywords
Body composition, Metabolism
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTVLCD-Active
Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.
OTHERMaintenance-Active
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.
DIETARY_SUPPLEMENTVLCD-Control
Lighter life VLCD products
OTHERMaintenance-Control
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.
Sponsors
US National Cattlemen´s Association
Danish Agriculture and Food Counsel
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
2x2 factorial intervention trial with two and two arms
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men or women * Age, 18-65 years * Overweight or grade I-II obesity (BMI 28-40.0 kg/m2) * Provided voluntary written informed consent
Exclusion criteria
(main: * Weight changes ± 5% in the last three months * Vegetarian, vegan * Pregnancy or lactation, pregnancy within the past 12 month or plans to become pregnant during the study * History or diagnosis of diabetes * History or diagnosis of heart, liver or kidney disease * History or diagnosis of eating disorders * Chronic diseases e.g. cancer within the past 5 years (except adequately-treated localized basal cell skin cancer) * Simultaneous blood donation for other purpose than this study * Simultaneous participation in other clinical intervention studies * Use of drugs, that in the opinion of the medically responsible investigator, are likely to affect the outcomes of the study * Any other condition that judged by the investigator may interfere with the adherence to the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | up to week 21 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation | Up to week 21 | Measurements of fasting CRP, plasma lipids |
| Resting metabolic rate | Up to week 21 | Resting metabolic rate will be measured by indirect calorimetry, using a ventilated hood system as described by the manufacture |
| Endocrine disruptors | Up to week 21 | Measurement of fasting T3 and T4 |
| Height | Week 0 | 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. |
| Waist circumference | Up to week 21 | 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. |
| Hip circumference | Up to week 21 | 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. |
| Blood pressure | Up to week 21 | 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 |
| Body composition | up to week 21 | Body composition will be assessed by DXA as whole body scan |
| Glucose metabolism | up to week 21 | Measurements of fasting glucose, insulin, HbA1c |
| Fecal samples | Up to week 21 | Measurement of microbiota (bacteria strains present in feces) and metabolomics markers |
Other
| Measure | Time frame | Description |
|---|---|---|
| Initial body composition | Up to week 21 | Statistical investigation of the effect of initial body composition assessed by DXA scan on weight change. |
| Physical activity and sleep | Up to week 21 | Physical activity and sleep patterns will be measured by an accelerometer (ActiGraph GT3X+) in the 7 days/8 nights |
| Perceived stress | Up to week 21 | Assessed by Perceived Stress Scale questionnaire |
| Life quality | Up to week 21 | Assessed by SF-36 questionnaire |
| Initial glucose metabolism | Up to week 21 | To investigate the effect of initial glucose metabolism on the response to high vs. moderate protein diet on weight maintenance. |
| Initial microbiota | Up to week 21 | Statistical investigation of the effect of initial microbiota assessed by fecal sample on weight change |
Countries
Denmark
Outcome results
None listed