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

NCT04886778 | Completed

• 1 other identifier: 2021LX0021_GY
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Carbohydrate-restricted diet; Probiotics; Efficacy and safety; Low-carbohydrate diet; Weight loss

Outcome Measures

Primary Outcomes (2)

• Changes in body weight.

  When measuring height, the subjects are required to take off their shoes, hats, and coats, keep their feet together in an upright position, keep their shoulders, head, and heels close to the ruler, and look straight ahead with the right-angle plate close to the top of the head. The measurement standard of height is accurate to 0.1cm. When measuring body weight, the subjects are required to take off their shoes, hats, and single clothes for measurement and the measurement standard of body weight is accurate to 0.1kg. Body mass index (BMI) is calculated by dividing body weight (kg) by the square of height (m2). All measurements will be performed by trained staff.

  At 12th week after the intervention.

• Incidence rate of adverse events.

  During the trial period, participants will attend several times face-to-face visits. At other times, participants will be contacted by investigators by phone to supervise their diets, to ensure compliance, to record observed side effects and adverse events in time.

  Up to 12 weeks.

Secondary Outcomes (18)

• Phased changes in body weight at 4th and 8th weeks.

  At 4th and 8th weeks after the intervention.

• Phased changes in body mass index at 4th and 8th weeks.

  At 4th and 8th weeks after the intervention.

• Changes in fasting blood glucose.

  At 12th week after the intervention.

• Changes in fasting insulin.

  At 12th week after the intervention.

• Changes in insulin resistance index (HOMA-IR) .

  At 12th week after the intervention.

Study Arms (2)

Group A or Trial group

EXPERIMENTAL

Group A was treated with a 12-week low-carbohydrate diet combined with probiotic compound preparations.

Dietary Supplement: Low-carbohydrate diet; Dietary Supplement: Probiotic compound preparations

Group B or Placebo control group

PLACEBO COMPARATOR

Group B was treated as a control group with a 12-week low-carbohydrate diet combined with placebo treatment.

Dietary Supplement: Low-carbohydrate diet; Dietary Supplement: Placebo

Interventions

Low-carbohydrate diet DIETARY_SUPPLEMENT

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.

Group A or Trial group; Group B or Placebo control group

Probiotic compound preparations DIETARY_SUPPLEMENT

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.

Also known as: Junyi Yili® Probiotics

Group A or Trial group

Placebo DIETARY_SUPPLEMENT

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.

Group B or Placebo control group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male;
• 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.

You may not qualify if:

• Subjects suffered from Secondary obesity including hypercortisolism, hypothyroidism, insulinoma, drug-induced obesity, etc.
• 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：
• Myocardial infarction.
• Cerebral infarction.
• Cardiac or revascularization surgery such as coronary artery bypass graft surgery and percutaneous transluminal coronary angioplasty.
• Unstable angina pectoris;
• Congestive heart failure diagnosed as Class III or IV of the New York Heart Association.
• 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.

Sponsors & Collaborators

• Sun Jia: lead

Study Sites (1)

The Pearl River Hospital of Southern Medical University

Guangzhou, Guangdong, 510300, China

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jia Sun, MD,PhD

  Zhujiang Hospital

  STUDY CHAIR

• Hong Chen, MD,PhD

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

• Zhen Zhang, MD,PhD

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

• Zhibo Wen, MD,PhD

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

• Yuting Ruan, MD,PhD

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

• Jitong Li, MD,PhD

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

• Qing Yang, MN

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-Chairman of the Department of Endocrinology and Metabolism，Chief Physician，Associate Professor，Doctor Supervisor of Endocrinology

Model Details: 44 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 experimental group, group A was treated with a 12-week low-carbohydrate diet combined with probiotic compound preparations, and group B was treated as a 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), in order 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.

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: May 14, 2021
• Study Start: June 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)