Healthy and Overweight/ Obesity Males Clinical Trial
Official title:
The Intervention Study of Dietary Intake on Energy Expenditure
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.
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.
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