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The Intervention Study of Dietary Intake on Energy Expenditure

Primary Purpose

Healthy and Overweight/ Obesity Males

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat diet

About this trial

This is an interventional prevention trial for Healthy and Overweight/ Obesity Males focused on measuring dietary intake, cross-over intervention, energy expenditure

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Male subjects, aged 18-45 years
20 normal weight (18.5≤ BMI<24) and 20 overweight / obesity (BMI ≥24)
No participating in other clinical studies within previous 3 months

Exclusion Criteria:

Alcoholic (100 grams of alcohol per drink, or 250 grams of rice wine, or 5 bottles of beer, ≥ 5 times a week)
Diabetic patients or the use of insulin, hypoglycemic agents
Taking antihypertensive drugs (diuretics, β blockers drugs, etc.) or lipid lowering drugs (class "bite", bile acids, statins, etc.) at present or once (within 6 months before the experiment)
Having serious cardiovascular and cerebrovascular diseases at present or before, may interfere with the normal operation of the experiment (such as heart failure, myocardial infarction, cerebral infarction, acute myocarditis, severe arrhythmia, receiving interventional therapy, etc.)
Having severe gastrointestinal diseases that affect food digestion and absorption, such as severe diarrhea in the past 3 months (3 or more times per day and lasting for 3 days or more); severe constipation in the past 3 months (2 times a week or less, accompanied by difficulties in defecation)
Having received drug treatment over the past 3 months due to the following diseases: cholecystitis, gastrointestinal ulcers; urinary tract infection, acute pyelonephritis, cystitis; having undergone any surgery, in addition to appendicitis, hernia surgery; having taken or taking drugs that will affect the digestion and absorption system
Attempting to change weight recently(weight loss, being on a diet, or weight gain)
Subjects with severe liver and kidney disease (alanine aminotransferase, serum creatinine exceeded 1.5 times of the normal range set by the hospital)
Subjects with severe thyroid disease (hyperthyroidism or hypothyroidism) or pituitary disease
Subjects with anemia (hemoglobin <120 g per liter)
Subjects with cancer or who have received radiotherapy or chemotherapy within five years
Having any mental illness; epilepsy patients or receiving antiepileptic treatment; using antidepressants
Suffering from AIDS, hepatitis A, hepatitis B or other infectious diseases
Physical disability

Sites / Locations

Institute for Nutritional Sciences, Chinese Academy of Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Normal weight group

Overweight/ obesity group

Arm Description

20 normal-weight males taking 3 types of assigned diets in random orders

20 overweight/ obesity males taking 3 types of assigned diets in random orders

Outcomes

Primary Outcome Measures

Respiratory Quotient

Respiratory quotient was measured in a metabolic chamber

Secondary Outcome Measures

Heart Rate

Heart rate (bpm) was measured by automatic heart rate meter

Glucose

Blood glucose (mg/dl) was measured using a automatic biochemical analyzer

Triglyceride

Blood triglyceride (mg/dl) was measured using a automatic biochemical analyzer

Full Information

NCT ID

NCT03231618

First Posted

July 21, 2017

Last Updated

January 24, 2018

Sponsor

Chinese Academy of Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03231618

Brief Title

The Intervention Study of Dietary Intake on Energy Expenditure

Official Title

The Intervention Study of Dietary Intake on Energy Expenditure

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

January 1, 2018 (Actual)

Study Completion Date

January 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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: the relationship between the proportion of macronutrients in diets and the energy metabolism efficiency. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy and Overweight/ Obesity Males

Keywords

dietary intake, cross-over intervention, energy expenditure

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal weight group

Arm Type

Experimental

Arm Description

20 normal-weight males taking 3 types of assigned diets in random orders

Arm Title

Overweight/ obesity group

Arm Type

Experimental

Arm Description

20 overweight/ obesity males taking 3 types of assigned diets in random orders

Intervention Type

Dietary Supplement

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 Description

Every participate was provided with 3 types of diets in random order

Primary Outcome Measure Information:

Title

Respiratory Quotient

Description

Respiratory quotient was measured in a metabolic chamber

Time Frame

1 hour after meal

Secondary Outcome Measure Information:

Title

Heart Rate

Description

Heart rate (bpm) was measured by automatic heart rate meter

Time Frame

1 hour after meal

Title

Glucose

Description

Blood glucose (mg/dl) was measured using a automatic biochemical analyzer

Time Frame

2 hour after meal

Title

Triglyceride

Description

Blood triglyceride (mg/dl) was measured using a automatic biochemical analyzer

Time Frame

2 hour after meal

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male subjects, aged 18-45 years 20 normal weight (18.5≤ BMI<24) and 20 overweight / obesity (BMI ≥24) No participating in other clinical studies within previous 3 months Exclusion Criteria: Alcoholic (100 grams of alcohol per drink, or 250 grams of rice wine, or 5 bottles of beer, ≥ 5 times a week) Diabetic patients or the use of insulin, hypoglycemic agents Taking antihypertensive drugs (diuretics, β blockers drugs, etc.) or lipid lowering drugs (class "bite", bile acids, statins, etc.) at present or once (within 6 months before the experiment) Having serious cardiovascular and cerebrovascular diseases at present or before, may interfere with the normal operation of the experiment (such as heart failure, myocardial infarction, cerebral infarction, acute myocarditis, severe arrhythmia, receiving interventional therapy, etc.) Having severe gastrointestinal diseases that affect food digestion and absorption, such as severe diarrhea in the past 3 months (3 or more times per day and lasting for 3 days or more); severe constipation in the past 3 months (2 times a week or less, accompanied by difficulties in defecation) Having received drug treatment over the past 3 months due to the following diseases: cholecystitis, gastrointestinal ulcers; urinary tract infection, acute pyelonephritis, cystitis; having undergone any surgery, in addition to appendicitis, hernia surgery; having taken or taking drugs that will affect the digestion and absorption system Attempting to change weight recently(weight loss, being on a diet, or weight gain) Subjects with severe liver and kidney disease (alanine aminotransferase, serum creatinine exceeded 1.5 times of the normal range set by the hospital) Subjects with severe thyroid disease (hyperthyroidism or hypothyroidism) or pituitary disease Subjects with anemia (hemoglobin <120 g per liter) Subjects with cancer or who have received radiotherapy or chemotherapy within five years Having any mental illness; epilepsy patients or receiving antiepileptic treatment; using antidepressants Suffering from AIDS, hepatitis A, hepatitis B or other infectious diseases Physical disability

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xu Lin

Organizational Affiliation

Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute for Nutritional Sciences, Chinese Academy of Sciences

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200031

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35849706

Citation

Sun L, Lin X. Reply to KR Short. J Nutr. 2022 Aug 9;152(8):2005-2006. doi: 10.1093/jn/nxac139. No abstract available.

Results Reference

derived

PubMed Identifier

35020917

Citation

Xiong Q, Sun L, Luo Y, Yun H, Shen X, Yin H, Chen X, Lin X. Different Isocaloric Meals and Adiposity Modify Energy Expenditure and Clinical and Metabolomic Biomarkers During Resting and Exercise States in a Randomized Crossover Acute Trial of Normal-Weight and Overweight/Obese Men. J Nutr. 2022 Apr 1;152(4):1118-1129. doi: 10.1093/jn/nxac006.

Results Reference

derived

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The Intervention Study of Dietary Intake on Energy Expenditure

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