Mediterranean Diet and Protein-Sparing Modified Diet for Metabolic Syndrome in Liver Transplant Recipients

NCT02174783 | Terminated

• 1 other identifier: PTMS-9500
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Many metabolic complications can develop after liver transplant including: diabetes, high blood pressure, obesity, heart attacks and stroke. The goal of this study is to look at the safety and effect of 2 well known and established diet regimens on the people who had a prior liver transplant and investigate whether it helps with the control of these comorbidities.

Conditions

Liver Transplantation; Metabolic Syndrome X; Obesity

Keywords

Weight Loss; Diet, Mediterranean; Diet, Reducing; protein sparing modified diet

Outcome Measures

Primary Outcomes (1)

• Weight loss

  6 months

Secondary Outcomes (5)

• Number of Participants with Serious and Non-Serious Adverse Events

  6 months

• Change in Hb A1c compared to baseline

  6 months

• Change in HDL and LDL compared to baseline

  6 months

• Change in triglyceride compared to baseline

  6 months

• Change in blood pressure compared to baseline

  6 months

Study Arms (3)

Control group

ACTIVE COMPARATOR

Standard of care group

Other: Control group

Mediterranean diet

EXPERIMENTAL

Mediterranean diet for 6 months

Other: Mediterranean diet

Protein-Sparing Modified Fast (PSMF)

EXPERIMENTAL

PSMF for 6 months

Other: Protein-Sparing Modified Fast (PSMF)

Interventions

Control group OTHER

Patient will be provided with basic nutrition educational materials that outline principles of a healthy diet, including: moderation, portion control, increased intakes of fruits, vegetables and whole grains and reduced intakes of saturated fat, salt and sugar. Brief education will be provided by the hepatologist without dietitian referral.

Control group

Mediterranean diet OTHER

Patient will receive verbal diet instruction from the dietitian or from the hepatologist who has received instruction from the dietitian on following the Mediterranean diet.

Mediterranean diet

Protein-Sparing Modified Fast (PSMF) OTHER

Patient will be referred to the dietitian for an appointment to discuss the PSMF plan. Protein needs of 1.5 grams/kilogram will be calculated based on patient's actual body weight. Patient will receive verbal instruction from the dietitian, as well as printed materials for reference at home. Dietitian will provide a list of allowed and prohibited foods as per Cleveland Clinic's PSMF diet standards.

Protein-Sparing Modified Fast (PSMF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients \> 18 years old who had a successful liver transplant at least 1 year prior to enrollment who also have a BMI\>30 with previous failed attempts at weight loss via conventional methods. In addition to one of the following:
• Triglyceride (TG)\>150 mg/dl or specific treatment for this lipid abnormality
• HDL \<40 mg/dl in females and \<50 mg/dl in males or specific treatment of this lipid abnormality
• Systolic BP \>130 or diastolic BP \>85 mm Hg or treatment for previously diagnosed hypertension
• Fasting plasma glucose \>100 mg/dl or previously diagnosed type 12 diabetes

You may not qualify if:

• Significant behavioral issues that would interfere with compliance
• Lack of readiness to change (pre-contemplation, contemplation or preparation stages)
• Previous bariatric surgery
• Pregnant or planning to become pregnant
• History of a documented eating disorder (e.g. bulimia)
• History of kidney stones

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Weight Loss

Interventions

Control Groups; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• mohammed Eyad Yaseen Alsabbagh, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Naim Alkhouri, MD

  The Cleveland Clinic

  STUDY DIRECTOR

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: June 23, 2014
• First Posted: June 26, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 14, 2017

Record last verified: 2014-07

Locations

US (1)