The Intervention Study of Dietary Intake on Energy Expenditure
Condition: Healthy and Overweight/ Obesity Males
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study is a randomized crossover (2 × 3) dietary intervention. 40 male volunteers(20
      normal weight, 20 overweight / obesity, no other serious disease or metabolic abnormalities)
      aged 18-45 years are required to take 3 kinds of isocaloric diets with different amounts of
      macronutrients: low-fat high-carbohydrate diets, low-carbohydrate high-fat diets and
      high-protein low-fat diets. The comparison is made within subject before and after the test
      meal. Each subject takes 6 meals of 3 kinds of diets on 6 separate days with a washout period
      between different diets. The study protocol was approved by the Ethics Committee of Shanghai
      Institutes for Biological Sciences and all participants provided written informed consents.
      The study is the first to investigate among overweight / obesity and normal weight in China
      to clarify:

        1. the relationship between the proportion of macronutrients in diets and the energy
           metabolism efficiency.

        2. the main genetic and non-genetic factors that impact individual energy metabolism, the
           characteristics of metabolic profiling and relative regulatory pathways.
    

Detailed description: 
      With the largest population of obesity and diabetes, China is suffering from heavy burden of
      obesity and major complications such as cardiovascular disease, type 2 diabetes and other
      major metabolic diseases ,which have become the major cause of disease death and continued to
      endanger the public health. In order to curb the incidence of obesity and its complications,
      more effective strategies are required to "prevent the move forward." With the arrival of
      "precise nutrition" era, precise weight management strategy for different sub-groups has
      become a hotspot of international research in this field.

      Healthy diet and lifestyle are worldwide recognized as the most important and effective ways
      of preventing chronic metabolic diseases such as obesity. Recently, different combinations of
      macronutrients including "low-fat + high carbon", "low carbon + high fat", and "high protein
      + low fat" draw much more attention instead of restriction on the total energy intake in the
      study of diet weight reduction strategy. However, it is noteworthy that most studies are
      focused on groups and conducted on the Western population. Studies of different dietary
      structure, genetic background and metabolic phenotypes of energy metabolism are still scarce,
      and data of Chinese population are lacking in this field.

      This study intends to provide 40 male volunteers aged 20-45 (20 normal weight, 20 overweight
      / obesity, no other serious illness or metabolic abnormalities) with three diets with
      different levels of macronutrients (low-fat + high-carbon foods, low-carbon + high-fat foods,
      and high-protein + low-fat foods) to 1) clarify the relationship between the ratio of
      macronutrients in diets and the energy metabolism efficiency; 2) investigate the effect of
      major genetic and non-genetic factors (age, obesity, adipose distribution and thyroid
      hormone) and metabolomics profiles on individual energy metabolism; 3) explore novel
      metabolic regulation networks. Ultimately, this study will provide basic data for discovering
      the energy metabolism efficiency of different dietary intervention and major genetic and
      non-genetic determinants, metabolic profile characteristics and regulatory pathways.
    

Intervention name(s): 1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat diet
Intervention type(s): Dietary Supplement
Intervention description(s): Every participate was provided with 3 types of diets in random order
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dietary intake; cross-over intervention; energy expenditure