Gastrointestinal Hormonal Regulation of Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01146704
First received: April 2, 2010
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

The objective of this study is to test and determine whether a high protein diet is efficacious, safe and beneficial to curtail food intake and body weight in obese adult human patients and to establish whether neurohormonal mechanisms of a high protein diet induce an early signal of fullness or satiety in a relevant experimental model, focusing on activation of gastric vagal afferents.


Condition Intervention
Obesity
Dietary Supplement: Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass
Dietary Supplement: Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate
Dietary Supplement: Very high protein diet group based on 1.4 gram of protein per pound of subject's lean body mass: 35% protein and 35% carbohydrate.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Gastrointestinal Hormonal Regulation of Obesity

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The primary endpoint is change in body weight, which is calculated as the difference between Day 1 (baseline) and 12 months. The primary objective is to compare the weight loss between each of the two high-protein diets and the standard diet. [ Time Frame: The primary outcome of weight loss is measured at the Baseline at Day 1, and at the end of the 12 months study period for each subject. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy variables: Nutrition assessments (FFQ, 3DFR, and Satiety Questionnaire), anthropometric profiles (e.g., waist and hip circumferences), lab and biochemical variables (e.g., insulin, lipid levels, HbA1c), body composition (body fat), hormone level [ Time Frame: The outcome of efficacy is measured at Day 1 Baseline and at monthly visits during the 12 month study period for each subject. ] [ Designated as safety issue: No ]
  • Safety variables: incidence, severity and duration of adverse events, vital signs, concomitant medications and physical examination results. [ Time Frame: Safety variables are measured at the time any adverse events occur, and vital signs, concomitant medications and physical examination results are measured at Baseline on Day 1 and monthly throughout the 12 month study period for each subject. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 198
Study Start Date: September 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories: 12.5% protein and 57.5% carbohydrate.
Dietary Supplement: Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass
Standard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 12.5% protein and 57.5% carbohydrate.
Other Name: Standard Protein Diet
Active Comparator: Arm 2
High protein diet group based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate.
Dietary Supplement: Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate
High level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 25% protein and 45% carbohydrate.
Other Name: High Level Protein Diet
Active Comparator: Arm 3
Very high protein diet group based on 1.4 gram of protein per pound of lean body mass: 35% protein and 35% carbohydrate.
Dietary Supplement: Very high protein diet group based on 1.4 gram of protein per pound of subject's lean body mass: 35% protein and 35% carbohydrate.
Very high protein diet, based on 1.4 gram of protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 35% protein and 35% carbohydrate.
Other Name: Very High Protein Diet

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For inclusion in the study, patients must fulfill all of the following criteria:

  • Subjects must be a veteran.
  • Subjects must sign the VA Greater Los Angeles Healthcare System Institutional Review Board approved written informed consent prior to the initiation of any study-related activities or study specific procedures or randomization.
  • Subjects must have given written authorization for the release of protected health information in compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations.

After the Informed Consent process, these additional Inclusion Criteria will be applied to potential subjects:

  • Age 21 years and older at screening.
  • BMI of 27 to 45 kg/m2 inclusive.
  • Subjects must be in good health as determined by medical history, physical examination performed by the Investigator (Study doctor) at the Screening stage, and screening clinical laboratory tests including chemistry panel and CBC.
  • Must have stable smoking habits (or be non-smokers) for at least 6 months prior to screening and agree not to intend to change such habits during the course of the study.
  • Subjects requiring the regular use of any prescription medication may be admitted to the study, providing the dose is stable.
  • Subjects must be able to communicate and cooperate with the Principal Investigator and the staff and willing to comply with the study instructions.

Exclusion Criteria:

  • Weight instability: Subjects reporting weight change of greater than 3.0 kg in the month prior to screening.
  • Any subject who has been on a very low calorie diet (less than 800 kcal/day) for a period of 4 months or more in the 12 months prior to screening, or who has lost greater than 10 kg in the 6 months prior to screening.
  • Any subject who has a history of diabetic gastroparesis or gastric emptying disorder as indicated in the potential subject's medical history and VA's Computer Patient Record System (CPRS).
  • Use of any other investigational drug(s) within 8 weeks prior to screening.
  • Abnormal laboratory parameters:
  • Serum creatinine greater than 1.6 mg/dL;
  • Liver function tests, ALT, AST, Bilirubin results greater than 2.0 times the upper limit of normal;
  • Triglycerides greater than 500 mg/dL;
  • Total cholesterol greater than 350 mg/dL;
  • TSH outside of normal range disorder, as indicated in the potential subject's medical history, the VA's Computer Patient Record System (CPRS) and laboratory tests performed during the screening process.
  • Subjects who drink more than 1 alcoholic beverage per day (that is: 1 beer; or 1 glass of wine; or 1 shot of liquor).
  • Pregnant women or women likely to become pregnant during the course of the study may not participate in this study. Female subjects must not be able to conceive by reason of surgery, radiation, one year past the onset of menopause, or an approved method of contraception.
  • No vulnerable subjects will be included in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146704

Contacts
Contact: Gigi Y Kwok (310) 478-3711 ext 48282 Gigi.Kwok@va.gov

Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA Recruiting
West Los Angeles, California, United States, 90073
Contact: Joseph R Pisegna, MD    310-268-3578    joseph.pisegna@va.gov   
Contact: David S Oh, MD    (310) 268-3283    David.Oh@va.gov   
Principal Investigator: Joseph R Pisegna, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Joseph R Pisegna, MD VA Greater Los Angeles Healthcare System, West LA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01146704     History of Changes
Other Study ID Numbers: F7219-R
Study First Received: April 2, 2010
Last Updated: September 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Obesity

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014