Efficacy and Safety of Low-Carbohydrate Diet Combined With Probiotics for Weight Loss in Male Obese Patients.

Summary

Over the years, increasing obesity prevalence represents an important threat to national and global public health. Many strategies studied for weight loss have reported that low-carbohydrate diets showed beneficial effects on weight loss for obese patients. However, individual weight losses have varied widely within low-carbohydrate diet groups due to the influence of gut microbiota, which was found in the previous clinical studies of our team (ChiCTR1800015156). Numerous animal studies and clinical trials have evaluated the impact of probiotics on glucose and lipid metabolism as well as weight-loss interventions. However, the effect of the different probiotic strains may play a different role in the same species. Therefore, our team isolated new strains (Lactobacillus reuteri PLBK1，GDMCC No: 60828、Lactobacillus reuteri PLBK2，GDMCC No: 60829、Lactobacillus gasseri PLBK3，GDMCC No: 60830、Lactobacillus acidophilus PLBK4，GDMCC No: 60831、Bifidobacterium lactis PLBK5，GDMCC No: 60832) from the oral cavity, feces or environment of the Chinese race in the previous study. The mixed solid beverage composed of these five strains has local characteristics and meets the requirements of the national standard for food additives, which has obtained the national food production license (SC10632028100205).In our previous animal experiments, the treatment of compound preparation of the above five strains improve insulin resistance and dyslipidemia effectively in obese mice induced by high-fat diet，which obtained significant weight loss . Nevertheless, clinical trials are needed to be carried out to confirm its clinical effect. Therefore, we aimed to conduct a randomized, double-blind, placebo-controlled prospective study on the basis of previous research. In order to evaluate the efficacy and safety, as well as the effect on glucose and lipid metabolism of low-carbohydrate diet combined with probiotics in obese participants, the study will last for 12 weeks. At the same time, Magnetic Resonance Imaging (MRI) will be used to clarify change in body fat distribution, which may provide more clinical evidence for the application of this program in the prevention and treatment of obesity in the future.

Conditions

• Obesity

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• Sun Jia

  lead OTHER

Principal Investigators

• Jia Sun, MD,PhD · Zhujiang Hospital

• Hong Chen, MD,PhD · Zhujiang Hospital

• Zhen Zhang, MD,PhD · Zhujiang Hospital

• Zhibo Wen, MD,PhD · Zhujiang Hospital

• Yuting Ruan, MD,PhD · Zhujiang Hospital

• Jitong Li, MD,PhD · Zhujiang Hospital

• Qing Yang, MN · Zhujiang Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2022-03-01

Completion

2022-03-01

Countries

• China

Study Locations