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| ID | Type | Description | Link |
|---|---|---|---|
| H-19041921 | Registry Identifier | Danish Ethical Committee |
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| Name | Class |
|---|---|
| US National Cattlemen´s Association | UNKNOWN |
| Danish Agriculture and Food Counsel | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VLCD-Control | Active Comparator | Very low calorie diet, 600 kcal pr day for eight weeks. |
|
| VLCD-Active | Experimental | Very low calorie diet plus additional 25 g protein powder, 700 kcal pr day for eight weeks. |
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| Maintenance-Control | Active Comparator | 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). |
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| Maintenance-Active | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VLCD-Active | Dietary Supplement | Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to week 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Body composition will be assessed by DXA as whole body scan | up to week 21 |
| Glucose metabolism | Measurements of fasting glucose, insulin, HbA1c |
| Measure | Description | Time Frame |
|---|---|---|
| Initial glucose metabolism | To investigate the effect of initial glucose metabolism on the response to high vs. moderate protein diet on weight maintenance. | Up to week 21 |
| Initial microbiota | Statistical investigation of the effect of initial microbiota assessed by fecal sample on weight change |
Inclusion Criteria:
Exclusion Criteria (main:
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| Name | Affiliation | Role |
|---|---|---|
| Arne Astrup, Professor | Department of Nutrition, Exercise and Sports, UCPH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Copenhagen | Frederiksberg | DK | 1958 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34749132 | Derived | Magkos F, Hjorth MF, Asping S, Rosenkrans MI, Rasmussen SI, Ritz C, Sjodin A, Geiker NRW. A protein-supplemented very-low-calorie diet does not mitigate reductions in lean mass and resting metabolic rate in subjects with overweight or obesity: A randomized controlled trial. Clin Nutr. 2021 Dec;40(12):5726-5733. doi: 10.1016/j.clnu.2021.10.006. Epub 2021 Oct 18. |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009748 | Nutrition Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000073600 | Diet, High-Protein |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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2x2 factorial intervention trial with two and two arms
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| Maintenance-Active | Other | 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. |
|
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| VLCD-Control | Dietary Supplement | Lighter life VLCD products |
|
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| Maintenance-Control | Other | 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. |
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| up to week 21 |
| Inflammation | Measurements of fasting CRP, plasma lipids | Up to week 21 |
| Fecal samples | Measurement of microbiota (bacteria strains present in feces) and metabolomics markers | 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 | Up to week 21 |
| Endocrine disruptors | Measurement of fasting T3 and T4 | 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. | 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. | 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. | 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 | Up to week 21 |
| Up to week 21 |
| Initial body composition | Statistical investigation of the effect of initial body composition assessed by DXA scan on weight change. | 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 | Up to week 21 |
| Perceived stress | Assessed by Perceived Stress Scale questionnaire | Up to week 21 |
| Life quality | Assessed by SF-36 questionnaire | Up to week 21 |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |