Effect of Dietary Interventions on Intestinal Flora and Metabolism

NCT04140851 | Unknown DMC

• 1 other identifier: DIIFM-20190701
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to explore the effects of dietary intervention on the figure, fatty liver and biochemical indexes; the intestinal flora and metabolomics of the overweight and obese patients. This study was a clinical control and self-control study (before and after), which enrolled 12 patients with simple overweight or obesity, including 9 males and 3 females. In addition, 20 patients with simple overweight or obesity were randomly selected by comparable age and gender to the control group (excluding criteria), including 11 males and 9 females, and another 20 healthy people were recruited to the healthy control group from the Physical Examination Center, Qilu Hospital of Shandong University.

Conditions

Dietary Interventions

Keywords

Dietary Interventions; Intestinal Flora; Metabolism

Outcome Measures

Primary Outcomes (2)

• The value of Ultrasound Attentunation Parameter in the overweight and obese patients

  Liver is detected by FibroTouch to get UAP showing liver steatosis in obesity

  3 months

• The serological indexes in the overweight and obese patients

  Serological testing gets a series of serological indicator, such as AST/ALT (U/L)

  3 months

Secondary Outcomes (2)

• The composition of immune cells in peripheral blood of the overweight and obese patients

  3 months

• The composition of intestinal flora of the overweight and obese patients

  3 months

Study Arms (3)

overweight/obesity diet intervention group

EXPERIMENTAL

Dietary fiber intervention

Dietary Supplement: Dietary fiber intervention

overweight/obese normal diet group

PLACEBO COMPARATOR

Normal diet

Dietary Supplement: Normal diet

healthy control group

NO INTERVENTION

Healthy people

Interventions

Dietary fiber intervention DIETARY_SUPPLEMENT

Dietary intervention

overweight/obesity diet intervention group

Normal diet DIETARY_SUPPLEMENT

Normal diet

overweight/obese normal diet group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• for the overweight/obesity group. Diagnostic criteria for overweight or obesity (basis): The classification standard% for the body mass index of Chinese population \[(BMI) = weight (kg)/height square (m\^2)\] recommended by the Working Group on Obesity of China (WGOC): obesity: BMI ≥ 28 kg/m\^2; overweight: 28 kg/m\^2 \> BMI ≥ 24 kg/m\^2; normal weight: 24 kg/m\^2 \> BMI ≥18.5 kg/m\^2; underweight: BMI \< 18.5 kg/m\^2;
• The subjects had not received weight loss treatment such as being on diet, diet drugs or surgery 6 months before the enrollment;
• The subjects signed the informed consent form, and were able and willing to adhere to low-carbohydrate diet and receive regular call and outpatient follow-up;

You may not qualify if:

• pregnant women, lactating women or women planning to get pregnant;
• the obesity caused by endocrine system and central nervous system diseases or drugs, type 2 diabetes, autoimmune diseases and other endocrine systemic diseases;
• history of acute or chronic infection, surgery or trauma, or history of malignant tumor;
• severe liver and kidney dysfunction (transaminase \> 2.5 times of normal upper limit); creatinine: male ≥ 133 μmol/L; female ≥ 124 μmol/L;
• the patients with severe heart, brain or peripheral vascular diseases;
• Those unable to cooperate with the observer for various reasons.
• The subjects withdrew from the criteria:
• being unable to continue the intervention due to other reasons or diseases during the treatment;
• being unsatisfied with the improvement in the symptoms during the treatment and requiring to stop the trial;
• having serious adverse events or adverse reactions, and the investigator considers it is necessary for the subject to terminate the trial from the medical perspective.

Sponsors & Collaborators

• Wuxi Hisky Medical Technology Co Ltd: lead
• Qilu Hospital of Shandong University: collaborator

Study Sites (1)

Liu Fuqiang

Jinan, Shandong, China

RECRUITING

Related Publications (5)

• Zhao L, Zhang F, Ding X, Wu G, Lam YY, Wang X, Fu H, Xue X, Lu C, Ma J, Yu L, Xu C, Ren Z, Xu Y, Xu S, Shen H, Zhu X, Shi Y, Shen Q, Dong W, Liu R, Ling Y, Zeng Y, Wang X, Zhang Q, Wang J, Wang L, Wu Y, Zeng B, Wei H, Zhang M, Peng Y, Zhang C. Gut bacteria selectively promoted by dietary fibers alleviate type 2 diabetes. Science. 2018 Mar 9;359(6380):1151-1156. doi: 10.1126/science.aao5774.

  PMID: 29590046 BACKGROUND

• Canfora EE, Meex RCR, Venema K, Blaak EE. Gut microbial metabolites in obesity, NAFLD and T2DM. Nat Rev Endocrinol. 2019 May;15(5):261-273. doi: 10.1038/s41574-019-0156-z.

  PMID: 30670819 BACKGROUND

• Thompson SV, Hannon BA, An R, Holscher HD. Effects of isolated soluble fiber supplementation on body weight, glycemia, and insulinemia in adults with overweight and obesity: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2017 Dec;106(6):1514-1528. doi: 10.3945/ajcn.117.163246. Epub 2017 Nov 1.

  PMID: 29092878 BACKGROUND

• Zhuang Xiaofang, et al. Evaluation of the performance of transient elastography in the diagnosis of nonalcoholic fatty liver disease. Journal of Clinical Hepatology, 33(12): 2366-2371.

  BACKGROUND

• Leng Xuejun. et al. Evaluation and comparison with FibroTouch® the degree of liver fibrosis in the patients with nonalcoholic fatty liver disease of different BMI levels. Journal of Clinical Hepatology, 34(9): 1891-1895.

  BACKGROUND

Study Officials

• Fuqiang Liu

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fuqiang Liu

CONTACT

18560083993; 54669716@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: this study enrolled 12 patients with simple overweight or obesity, including 9 males and 3 females. In addition, 20 patients with simple overweight or obesity were randomly selected by comparable age and gender to the control group (excluding criteria), including 11 males and 9 females, and another 20 healthy people were recruited to the healthy control group.

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 28, 2019
• Study Start: July 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 28, 2019

Record last verified: 2019-10

Locations

CN (1)