Efficacy and Safety of Low-Carbohydrate Diet Combined With Probiotics for Weight Loss in Male Obese Patients.
NCT ID: NCT04886778
Last Updated: 2024-03-13
Study Results
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Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2021-06-01
2022-03-01
Brief Summary
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Detailed Description
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Forty-four obese participants who meet the inclusion/exclusion criteria are randomly assigned to group A and group B at a ratio of 1:1. As the trial group, group A was treated with a 12-week low-carbohydrate diet combined with probiotic compound preparations, and group B was treated as a placebo control group with a 12-week low-carbohydrate diet combined with placebo treatment. Since the probiotic compound preparation is made of Lactobacillus reuteri, Lactobacillus gasseri, Lactobacillus acidophilus, Bifidobacterium lactis, and resistant dextrin (water-soluble dietary fiber), to eliminate the effect of resistant dextrin (water-soluble meal fiber) on the experimental results, the placebo is prepared from resistant dextrin (water-soluble meal fiber) and is packaged to be consistent with the appearance of the probiotic compound preparation.
During the trial period, participants will attend face-to-face visits at 4-week (visit 3), 8-week (visit 4), and 12-week (visit 5). During each follow-up visit, participants will be asked about their dietary structure, average daily calorie intake, exercise volume, adverse events, and so on. Research assistants will record their heart rate, blood pressure, height, weight, BMI, waist circumference, and waist-to-hip ratio. During the 12-week (visit 5), research assistants will record fasting blood glucose, fasting insulin, insulin resistance index (HOMA-IR), biomarkers of lipids metabolism (TG/TC/LDL/HDL), subcutaneous fat and visceral fat volume, the fat fraction (FF). Fecal samples will be collected by participants at baseline as well as at the end stage and be divided into 10 parts, each one is about 200-300mg. All fecal samples will be stored in a -80 ℃ freezer by researchers. At the end of the experiment, fecal samples will be uniformly sent to Metabo-Profile Biotechnology (Shanghai) Co., Ltd. to detect the composition of gut microbes.
The data of this project will be collected from the Department of Endocrinology and Metabolism, Zhujiang Hospital of Southern Medical University. Relevant information will be obtained by consulting the inspection system and asking patients. All data will be recorded independently by two specialized statisticians.
Data management strictly abides by relevant regulations, and any transfer of electronic data or subject-related data must be approved by the data management department. In case data is transmitted through non-secure electronic networks, corresponding data protection rules must be followed.
The statistical methods are as follow:
1. General analysis: In this study, if no special instructions are given, the data will be described and analyzed according to the following general principles. Statistics description: The mean, standard deviation and confidence interval will be given in measurement data, and if necessary, the minimum, maximum, P25, median and P75 will be given. When the non-parametric method is used, the median and interquartile range will be given. The frequency distribution and the corresponding percentage will be given in counting data. The frequency distribution and the corresponding percentage and average rank will be given in grade data. Basic principles: All statistical inferences use two-sided tests, the statistically significant test level is set at 0.05, and the confidence interval of the parameters is estimated to be 95% confidence interval. The comparison of counting data between groups depends on the theoretical frequency, using χ2 test, continuous correction χ2 test or Fisher's exact probability method. Two independent sample T-tests is used to compare normally distributed baseline measurement data between groups. For non-normal distribution baseline measurement data, the Wilcoxon rank sum test is used for comparison between groups. Continuous variables measured at multiple time points are analyzed using a Mixed effect model. p\<0.05 is considered significant in the study. Missing data: The mixed linear model will be used to obtain the point estimation and standard deviation of the treatment effect. The Markov chain Monte Carlo method is used to fill in the missing data in the multivariate analysis. Abnormal data: Interquartile range whose observation value is greater than P75 or less than P25 more than 3 times will be judged as outlier data. In the analysis process, sensitivity analysis will be used for outlier data, that is, both retention and elimination of outlier data are analyzed. If the results are not contradictory, the data will be retained; if contradictory, it will be depended on the specific situation.
2. Basic characteristics: The mean, standard deviation, median, maximum and minimum will be calculated for quantitative data such as age, height, weight and BMI. The frequency and percentage will be listed for qualitative information such as gender.
3. Efficacy analysis: The efficacy analysis will be based on the Full Analysis Set (FAS). Analysis of the main efficacy indicators: the extent of weight loss during the trial period is a continuous variable, so that the results will be analyzed using Mixed effects model. In the model, subject factors are considered as random effects and intervention, time and mutual interaction effects are considered as fixed effects.Analysis of secondary efficacy indicators: After 12-week intervention, the continuous variables such as insulin resistance indicators, waist circumference, waist-to-hip ratio, lipids (TG/TC/LDL/HDL), body fat percentage (BF%), subcutaneous and visceral adipose tissue volume, fat fraction (FF) compared with the baseline will be analyzed by mixed effects model. Other categorical variables are analyzed using χ2 test, continuous correction χ2 test or Fisher's exact probability method.
4. Security analysis: The safety rating will be based on the safety set (SS), with descriptive statistical analysis as the main focus. The adverse events, serious adverse events and reactions occurred in the two groups will be analyzed. An adverse reaction is defined as an adverse event that has a relationship with the study drug as "definitely related or may be related or undeterminable". The laboratory results that are normal before the trial but abnormal after treatment will be described. The mean, standard deviation, median, minimum and maximum values of blood pressure, heart rate and laboratory indicators before and after the intervention in the two groups, as well as the number and rate of "normal turned abnormal" or "abnormal aggravation" of vital signs and laboratory indicators will be calculated.
5. Sensitivity analysis: Sensitivity analysis will be performed after missing data filling and abnormal data elimination.
6. Statistical software and general requirements: SPSS 24.0 statistical software is used for data entry and statistical analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A or Trial group
Group A was treated with a 12-week low-carbohydrate diet combined with probiotic compound preparations.
Low-carbohydrate diet
Participants will be instructed to maintain a daily dietary energy intake of less than 1600 kcal.Based on the low-carbohydrate diet model, the proportion of daily intake of carbohydrate was about 30%, and this ratio was up to 30%, 40% of protein and fat respectively.Participants should choose unprocessed whole grains, potatoes, vegetables, meat, fish, eggs, soy products, sugar-free dairy products, designated varieties of low-GI fruits and nuts, etc. as breakfast, and avoid processed meats and high-fat red meat and poultry skins. Standard nutritious meal instead of daily lunch and dinner meals, that is to say, participants should take one nutritional bar for lunch and dinner (310 kcal totally, provided by Guangzhou Nanda Fett Nutrition and Health Consulting Co., Ltd.), and avoid starchy foods. Other food varieties are required to be the same as breakfast. Plant oil is the main cooking oil, and participants will be instructed to drink 2L water every day.
Probiotic compound preparations
The probiotic compound preparation，named Junyi Yili® Probiotics，is made of Lactobacillus reuteri, Lactobacillus gasseri, Lactobacillus acidophilus and Bifidobacterium lactis, and resistant dextrin contained water-soluble dietary fiber. The subjects will take this probiotic compound preparations with purified water after three meals every day, 1 sachet each time.
Group B or Placebo control group
Group B was treated as a control group with a 12-week low-carbohydrate diet combined with placebo treatment.
Low-carbohydrate diet
Participants will be instructed to maintain a daily dietary energy intake of less than 1600 kcal.Based on the low-carbohydrate diet model, the proportion of daily intake of carbohydrate was about 30%, and this ratio was up to 30%, 40% of protein and fat respectively.Participants should choose unprocessed whole grains, potatoes, vegetables, meat, fish, eggs, soy products, sugar-free dairy products, designated varieties of low-GI fruits and nuts, etc. as breakfast, and avoid processed meats and high-fat red meat and poultry skins. Standard nutritious meal instead of daily lunch and dinner meals, that is to say, participants should take one nutritional bar for lunch and dinner (310 kcal totally, provided by Guangzhou Nanda Fett Nutrition and Health Consulting Co., Ltd.), and avoid starchy foods. Other food varieties are required to be the same as breakfast. Plant oil is the main cooking oil, and participants will be instructed to drink 2L water every day.
Placebo
Placebo is made of resistant dextrin which contained water-soluble dietary fiber. The subjects were taken this placebo with purified water after three meals every day, 1 sachet each time.
Interventions
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Low-carbohydrate diet
Participants will be instructed to maintain a daily dietary energy intake of less than 1600 kcal.Based on the low-carbohydrate diet model, the proportion of daily intake of carbohydrate was about 30%, and this ratio was up to 30%, 40% of protein and fat respectively.Participants should choose unprocessed whole grains, potatoes, vegetables, meat, fish, eggs, soy products, sugar-free dairy products, designated varieties of low-GI fruits and nuts, etc. as breakfast, and avoid processed meats and high-fat red meat and poultry skins. Standard nutritious meal instead of daily lunch and dinner meals, that is to say, participants should take one nutritional bar for lunch and dinner (310 kcal totally, provided by Guangzhou Nanda Fett Nutrition and Health Consulting Co., Ltd.), and avoid starchy foods. Other food varieties are required to be the same as breakfast. Plant oil is the main cooking oil, and participants will be instructed to drink 2L water every day.
Probiotic compound preparations
The probiotic compound preparation，named Junyi Yili® Probiotics，is made of Lactobacillus reuteri, Lactobacillus gasseri, Lactobacillus acidophilus and Bifidobacterium lactis, and resistant dextrin contained water-soluble dietary fiber. The subjects will take this probiotic compound preparations with purified water after three meals every day, 1 sachet each time.
Placebo
Placebo is made of resistant dextrin which contained water-soluble dietary fiber. The subjects were taken this placebo with purified water after three meals every day, 1 sachet each time.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 to 35 years old;
* BMI≥28kg/m2;
* No contraindications for MRI examination;
* No alcohol intake, no use of any probiotic-related foods or medications, antibiotics, hormones and weight-loss products in the past three months;
* No other metabolic diseases;
* Volunteering to participate in and cooperate with the research and sign the written informed consent.
Exclusion Criteria
* Obesity-related complications that may be life-threatening or cause serious consequences in the short term have occurred.
* Any of the following cardiovascular diseases have occurred in the past：
1. Myocardial infarction.
2. Cerebral infarction.
3. Cardiac or revascularization surgery such as coronary artery bypass graft surgery and percutaneous transluminal coronary angioplasty.
4. Unstable angina pectoris;
5. Congestive heart failure diagnosed as Class III or IV of the New York Heart Association.
6. Transient ischemic attack or significant cerebrovascular disease.
* Patients with symptoms of gastrointestinal diseases, including intestinal obstruction, intestinal ulcer and gastrointestinal bleeding.
* A history of gastrointestinal surgery, such as bariatric surgery, banding surgery, gastrointestinal anastomosis and enterectomy.
* A state of known immunodeficiency, including but not limited to individuals who have experienced organ transplantation or acquired immunodeficiency syndrome (AIDS).
* Subjects who cannot comply with the protocol and patients with serious physical or psychological diseases that may affect the effectiveness or safety under the judgment of the investigator.
* Patients who cannot cooperate to complete the entire intervention and follow-up due to various other factors.
18 Years
35 Years
MALE
No
Sponsors
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Sun Jia
OTHER
Responsible Party
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Sun Jia
Vice-Chairman of the Department of Endocrinology and Metabolism，Chief Physician，Associate Professor，Doctor Supervisor of Endocrinology
Principal Investigators
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Jia Sun, MD,PhD
Role: STUDY_CHAIR
Zhujiang Hospital
Hong Chen, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Zhujiang Hospital
Zhen Zhang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Zhujiang Hospital
Zhibo Wen, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Zhujiang Hospital
Yuting Ruan, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Zhujiang Hospital
Jitong Li, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Zhujiang Hospital
Qing Yang, MN
Role: PRINCIPAL_INVESTIGATOR
Zhujiang Hospital
Locations
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The Pearl River Hospital of Southern Medical University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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2021LX0021_GY
Identifier Type: -
Identifier Source: org_study_id
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