NCT04871880

Brief Summary

Lifestyle changes aiming at weight loss remain the cornerstone of MAFLD treatment.Evaluating the motivational stage of patients' change and providing targeted lifestyle guidance may significantly improve the efficiency of weight loss. The investigators hypothesize that gut microbiota may affect motivation to lose weight, and the changes in gut microbiota due to weight loss may positively feedback the behavior of motivation, forming a virtuous circle. Thus, this study aims at ①evaluating the relationships between motivational stage of weight loss and the gut microbiota (Gut-brain axis); ②investigating the effects of lifestyle interventions on the gut microbiota in MAFLD patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 4, 2021

Status Verified

April 1, 2021

Enrollment Period

4 years

First QC Date

April 20, 2021

Last Update Submit

April 29, 2021

Conditions

Metabolic Associated Fatty Liver Disease

Outcome Measures

Primary Outcomes (3)

  • Hepatic fat

    Change of liver proton density fat fraction (PDFF) in MAFLD assessed by magnetic resonance imaging (MRI)

    12 months

  • Obesity

    Changes in body weight

    1, 4, 8, 12, 24 months

  • Gut microbiota

    Changes in bacterial component of the gut microbiome

    1, 4, 8, 12, 24 months

Secondary Outcomes (9)

  • Blood pressure

    1, 4, 8, 12, 24 months

  • Central obesity

    1, 4, 8, 12, 24 months

  • Insulin resistance

    1, 4, 8, 12, 24 months

  • FPG

    1, 4, 8, 12, 24 months

  • HbA1c

    1, 4, 8, 12, 24 months

  • +4 more secondary outcomes

Study Arms (2)

Dietitian led life style modification intervention.

EXPERIMENTAL

Lifestyle changes supervised by dietitians

Behavioral: Dietitian led life style modification intervention

Conventional care (control)

EXPERIMENTAL

Receive routine care

Behavioral: Conventional care (control)

Interventions

Dietitian led life style modification interventionBEHAVIORAL

All participants received recommendations for a low-fat hypocaloric diet that was 750 kcal/day less than their daily energy need which supervised by dietitians. Additionally, patients were encouraged to walk 200 minutes per weeks and a short self-report questionnaire for the measurement of habitual physical activity was implemented at baseline, 4, 16, 32 and 48 weeks.

Dietitian led life style modification intervention.
Conventional care (control)BEHAVIORAL

Receive routine care

Conventional care (control)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • With age range of 18-65 years.
  • BMI ≥ 28kg/m2
  • Fatty infiltration of the liver was confirmed on imaging studies (ultrasound, transient elastography, computed tomography, or magnetic resonance imaging) or liver biopsy.
  • With valid motivational stage assessment based on TTM.
  • Written consent form obtained.

You may not qualify if:

  • History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and Inherited metabolic liver diseases) and hemochromatosis.
  • Self-reported HIV-positive status, active tuberculosis, active malaria, or inflammatory bowel disease.
  • Excessive alcohol consumption (\>30g/d for men and \>20g/d for women).
  • Patient has known cirrhosis (compensated/decompensated) either based on clinical criteria or liver histology or Imaging techniques.
  • Subjects using thyroid hormones, oestrogens, amiodarone, steroids, tamoxifen and other medicine known to affect liver fat accumulation.
  • Subjects using thiazolidinedione hypoglycemic drugs, vitamin E and other medicine have potential benefits for NASH within six months.
  • Subjects with organ failure.
  • Subjects with hepatocellular carcinoma or other active malignancy.
  • Solid organ transplant recipients.
  • Antibiotic treatment within the previous 3 months.
  • Suffering from any acute or chronic cardiovascular, GI or immunological condition.
  • Gastric or duodenal ulcer in the past six months.
  • Currently pregnant or nursing.
  • Concomitant diseases with reduced life expectancy.
  • Combined mental illness.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Central Study Contacts

Jinjun Chen

CONTACT

8618588531001chjj@smu.edu.cn

Ling Zhou

CONTACT

8613631383539vzhouling3168@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

May 4, 2021

Study Start

May 17, 2020

Primary Completion

May 17, 2024

Study Completion

December 30, 2024

Last Updated

May 4, 2021

Record last verified: 2021-04

Locations

CN(1)