Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease

  • STATUS
    Recruiting
  • End date
    Oct 9, 2023
  • participants needed
    16
  • sponsor
    University of Nottingham
Updated on 9 October 2021

Summary

A 2 x 2 cross-over dietary intervention trial designed to investigate the effects of low glycemic index (LGI) versus high glycemic index (HGI) diet on hepatic fat accumulation and gut microbiota composition in participants with NAFLD.

Participants will be allocated randomly to a 2-week either high GI (HGI) or low GI (LGI) diet followed by a 4-week wash-out period and then the LGI or HGI diet, opposite to the first 2-weeks (N= 16).

Details
Condition steatohepatitis, LIVER DISEASE, Nutritional and Metabolic Disease, Liver Disease, Liver Disorders, Fatty Liver, hepatic steatosis
Treatment Low Glycemic Index Diet, High glycemic index diet
Clinical Study IdentifierNCT04415632
SponsorUniversity of Nottingham
Last Modified on9 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult males and females aged from 18 to 65 years (balanced number)
Detected NAFLD by CAP-FibroScan >288dB/m or by MRI-PDFF) > 5% fat of liver weight
Body mass index 25 kg/m2
Have current moderate to high GI diet intake of 60 (Assessed from a completed 7-day food diary)
Abdominal obesity (Waist circumference > 102 cm for males and > 88 cm for females)
Able to give informed consent
Able to undergo MRI/S and CAP-FibroScan

Exclusion Criteria

Current smokers and excessive alcohol drinkers (> 14 units/week)
Perimenopausal (irregular periods) women
Participants with other liver abnormalities
Participants with history of gastrointestinal surgeries, depression, eating disorders or difficulties
Participants using pharmacologic agents for obesity or NAFLD
Participants with type 1 diabetes
Participants with type 2 diabetes on second line medications (eg GLP-1 analogues, sulfonylureas)
Participation in any other trial in the last 3 months
Participants on any special diets (e.g. vegetarians)
Intolerance to foods included in the diet plan
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note