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Overweight and obesity (i.e., excess body fat) is a worldwide health problem, which predisposes individuals to various metabolic diseases. Weight loss through lifestyle modifications such as dietary calorie restrictions and/or exercise are effective approaches to reduce excess body fat. However, lean muscle mass loss is often an undesired outcome associated with weight loss, which should be avoided, particularly in older adults, who are also faced with declining anabolic responses to dietary protein intake. Given the increased interest and popularity of plant-based diets, in this study we will compare two distinct calorie-restricted, weight loss diets, both supplemented with weekly exercise, predominantly consisting of either plant-based proteins or animal-based proteins on changes in total body weight, body fat and lean muscle mass, as well as associated changes in metabolic health.
Overweight and obesity is a worldwide health problem which are linked to a plethora of age associated chronic diseases such as diabetes, cardiovascular diseases, hypertension and certain cancers. Lifestyle modifications including calorie-restricted diet and/or exercise are effective, non-invasive strategies to combat this burden. However, due to the age-associated muscle atrophy, consisting of reduced muscle functional status and anabolic resistance, calorie restriction to combat obesity is complicated by concomitant loss of skeletal muscle strength and function. Furthermore, in recent times, due to reasons of sustainability and health, there have been substantial attention on the use of alternative proteins to meet dietary protein requirements.
While increased intake of animal proteins is effective in preserving lean muscle mass, to what extent they apply for plant proteins are still a matter of intense debate. Therefore, in this study we will evaluate and compare two distinct calorie restricted dietary interventions, one predominantly consisting of plant-based proteins and another predominantly consisting of animal-based proteins, both supplemented with increased exercise, on their effectiveness to reduce body fat and preserving lean muscle mass. This will be a 16 week, parallel design, randomized dietary intervention trial, in older Chinese adults, with each volunteer being provided with 2 of their 3 main meals per day, along with a mid-morning beverage, made predominantly of either plant protein or animal protein sources and being asked to undertake 3 hours of additional exercise per week. More details provided in sections below.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Calorie Control Group | Active Comparator | The control group will receive 2x calorie-restricted balanced meals per day, each consisting of a portion of animal proteins (~20g), a portion of vegetables, and a portion of starch (rice/ noodles) per meal. The group will also receive a mid-morning beverage in the form of a malted drink (~150 kcal and ~5g protein). The third meal of the day and any additional snacks will be left to the free choice of the participants, with calorie advice provided by study dietitian. Calorie restriction aims to reduce body weight of individual participants by ~5 - 10%. The group will also be asked to undergo a supervised mixed exercise regime three days per week, 1 hour per day. The mixed exercise regime will consist of 2 sessions of resistance training and 1 session of aerobic training. |
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| Low-Calorie Treatment Group | Active Comparator | The treatment group will receive 2x calorie-restricted balanced meals per day, each consisting of a portion of plant proteins (~25g), a portion of vegetables, and a portion of starch (rice/noodles) per meal. The group will also receive a mid-morning beverage, in the form of a soy-based, plant protein beverage (~120 kcal and 13g protein). The third meal of the day and any additional snacks will be left to the free choice of the participants, with calorie advice provided by study dietitian. Calorie restriction aims to reduce body weight of participants by ~5 - 10%. The group will also be asked to undergo a supervised mixed exercise regime three days per week, 1 hour per day. The mixed exercise regime will consist of 2 sessions of resistance training and 1 session of aerobic training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Calorie Animal Protein Meals | Combination Product | Consume reduced calorie ready meals with animal proteins to substitute participants' two main meals/day plus a serving of malted beverage to be consumed every day for a period of 16 weeks. Additional supervised exercise regime made up of 2 hours of resistance training plus 1 hour of aerobic training per week for a period of 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass | kg | 16 weeks (from first to final measurement visits) |
| Body Fat % | 16 weeks (from first to final measurement visits) | |
| Muscle Mass | kg | 16 weeks (from first to final measurement visits) |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | mmol/mol (%) | 16 weeks (from first to final measurement visits), measured every 8 weeks |
| Fasting glucose | mmol/L | 16 weeks (from first to final measurement visits), measured every 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition Research Centre | Singapore | 117599 | Singapore |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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| Low Calorie Plant Protein Meals | Combination Product | Consume reduced calorie ready meals with plant proteins to substitute participants' two main meals/day plus a serving of soy-based plant protein beverage to be consumed every day for a period of 16 weeks. Additional supervised exercise regime made up of 2 hours of resistance training plus 1 hour of aerobic training per week for a period of 16 weeks. |
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| Fasting insulin | pmol/L | 16 weeks (from first to final measurement visits), measured every 4 weeks |
| Oral glucose tolerance test | mmol/L | 16 weeks (from first to final measurement visits), measured every 8 weeks |
| Blood lipid profile (HDL, LDL, Total Cholesterol, Triglyceride) | mmol/L | 16 weeks (from first to final measurement visits), measured every 4 weeks |
| C-Reactive Protein | mg/L | 16 weeks (from first to final measurement visits), measured every 8 weeks |
| IL-6 (Interleukin 6) | pg/mL | 16 weeks (from first to final measurement visits), measured every 8 weeks |
| TNF-α (Tumor Necrosis Factor - alpha) | pg/mL | 16 weeks (from first to final measurement visits), measured every 8 weeks |
| Leptin | ng/mL | 16 weeks (from first to final measurement visits), measured every 8 weeks |
| β-hydroxybutyrate | mmol/L | 16 weeks (from first to final measurement visits), measured every 8 weeks |
| Acetoacetate | mcg/mL | 16 weeks (from first to final measurement visits), measured every 8 weeks |
| TMAO (Trimethylamine N-Oxide) | μM | 16 weeks (from first to final measurement visits), measured every 8 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |