Healthy and Overweight/ Obesity MalesNCT03231618
The Intervention Study of Dietary Intake on Energy Expenditure
A study testing 1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat diet in people with Healthy and Overweight/ Obesity Males, run by Chinese Academy of Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy and Overweight/ Obesity Males
- What is being tested?
- 1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Institute for Nutritional Sciences, Chinese Academy of Sciences
Shanghai, Shanghai Municipality, 200031
About this study
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.
Read the 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.
- Conditions
- Healthy and Overweight/ Obesity Males
- Being tested
- 1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat diet
- Keywords
- dietary intake, cross-over intervention, energy expenditure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat dietDietary supplement
Every participate was provided with 3 types of diets in random order
| Study group | Role | What they receive |
|---|---|---|
| Normal weight group | Experimental | 20 normal-weight males taking 3 types of assigned diets in random orders Receives: Dietary Supplement: 1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat diet |
| Overweight/ obesity group | Experimental | 20 overweight/ obesity males taking 3 types of assigned diets in random orders Receives: Dietary Supplement: 1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Quotient
Respiratory quotient was measured in a metabolic chamber
Measured: 1 hour after meal
Secondary outcomes (3)
Heart Rate
Heart rate (bpm) was measured by automatic heart rate meter
Measured: 1 hour after meal
Glucose
Blood glucose (mg/dl) was measured using a automatic biochemical analyzer
Measured: 2 hour after meal
Triglyceride
Blood triglyceride (mg/dl) was measured using a automatic biochemical analyzer
Measured: 2 hour after meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start1 Sep 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy and Overweight/ Obesity MalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xu Lin, Chinese Academy of Sciences
- Investigators
- Xu Lin, Principal investigator, Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231618
- Sponsor's protocol ID
- ChineseAS-201709
- Status last verified
- Jan 2018
- First submitted
- 21 Jul 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35849706Xiong 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.
PubMed 35020917
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intervention Study of Dietary Intake on Energy Expenditure
- ClinicalTrials.gov ID
- NCT03231618
- Acronym / sponsor ID
- ChineseAS-201709
- Conditions
- Healthy and Overweight/ Obesity Males
- Keywords
- dietary intake, cross-over intervention, energy expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight group | Experimental | Dietary Supplement: 1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat diet20 normal-weight males taking 3 types of assigned diets in random orders |
| Overweight/ obesity group | Experimental | Dietary Supplement: 1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat diet20 overweight/ obesity males taking 3 types of assigned diets in random orders |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat dietEvery participate was provided with 3 types of diets in random order | Dietary supplement | Normal weight group, Overweight/ obesity group |
Primary outcome
Respiratory Quotient
Time frame: 1 hour after meal
Respiratory quotient was measured in a metabolic chamber
3 secondary outcomes
Heart Rate
Time frame: 1 hour after meal
Glucose
Time frame: 2 hour after meal
Triglyceride
Time frame: 2 hour after meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Derived from this study: PubMed 35849706Sun L, Lin X. Reply to KR Short. J Nutr. 2022 Aug 9;152(8):2005-2006. doi: 10.1093/jn/nxac139. No abstract available.
- Derived from this study: PubMed 35020917Xiong 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu Lin principal investigator
Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat diet in people with Healthy and Overweight/ Obesity Males, run by Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Quotient (time frame: 1 hour after meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231618, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.