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Completed

NCT Number: NCT02491229

"Hepafast" in Non-alcoholic Fatty Liver Disease (NAFLD)

The purpose of this study is to investigate whether a weight reduction with "Hepafast" in combination with raw food and vegetables for two weeks followed by a meal substitution with "Hepafast" and a calorie restriction in accordance with the Low Glycemic and Insulinemic Diet (LOGI) for 10 weeks is superior regarding improvement of non-alcoholic Fatty Liver Disease (NAFLD) compared to a conventional weight reduction in accordance with the LOGI diet without use of "Hepafast" for 12 weeks.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease (NAFLD) Body Weight Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hohenheim

Stuttgart, 70599, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI between 30-40 kg/m2
  • suspected or diagnosed non-alcoholic fatty liver disease (NAFLD)

Exclusion criteria

  • other liver diseases
  • kidney failure
  • pregnancy, lactation
  • diabetes mellitus which is treated with insulin
  • alcohol abuse
  • several drugs

Treatment and study plan

Hepafast

Other

Two weeks of Hepafast three times a day and additionally 200 kcal followed by 10 weeks of Hepafast two times a day and a meal according to LOGI diet

LOGI diet

Other

For twelve weeks, this group eats meals according to the Low Glycemic and Insulinemic Diet (LOGI).

Primary outcomes

  1. change from baseline in hepatorenal index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

Secondary outcomes

  1. change from baseline in fatty liver index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

  2. change from baseline in the classification of non-alcoholic fatty liver disease (NAFLD) based on ultrasound at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

  3. change from baseline in body weight at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Examinations take place at two weeks, six weeks and twelve weeks.

  4. change from baseline in blood pressure (systolic and diastolic) at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

  5. change from baseline in GGT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

  6. change from baseline in GOT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

  7. change from baseline in GPT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

  8. change from baseline in AP at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

  9. change from baseline in triglycerides at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

  10. change from baseline in HDL cholesterol at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

  11. change from baseline in LDL cholesterol at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

  12. change from baseline in fasting glucose at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

  13. change from baseline in insulin at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

  14. change from baseline in HbA1c at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

  15. change from baseline in hsCRP at two weeks, six weeks and twelve weeks after starting a defined way of nutrition

    Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Collaborators

  • Bodymed AG

Registry information

Official study title

Clinical Trial for Investigating the Effects of "Hepafast" on Non-alcoholic Fatty Liver Disease (NAFLD)

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 7, 2015
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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