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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01146704
Other study ID # F7219-R
Secondary ID
Status Recruiting
Phase N/A
First received April 2, 2010
Last updated July 25, 2017
Start date September 1, 2010
Est. completion date December 31, 2019

Study information

Verified date July 2017
Source VA Office of Research and Development
Contact Vivek Dixit, PhD
Phone (310) 478-3711
Email Vivek.Dixit@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Obesity is a major cause of morbidity and mortality within the VA medical system accounting for the majority of cases of diabetes mellitus, hypertension, coronary artery disease and cerebrovascular accidents. An improved understanding of the regulation of body weight in Veteran obese patients will improve the quality of life by avoidance of serious medical complications and by suggesting novel therapeutic approaches.

The large proportion of the Veteran population that frequent the VA health care system and who suffer from obesity or have obesity-related illnesses can benefit from this research.

Obesity is associated with early mortality in the United States. It has been estimated to result in about 280,000 deaths per year in U.S. adults and the expenses related to obesity are in excess of $80 billion. Obesity is a major cause of morbidity and mortality within the VA medical system accounting for the majority of cases of diabetes mellitus, hypertension, coronary artery disease and cerebrovascular accidents.

The proposed studies will address important physiological questions regarding the mechanisms of gut peptides regulating satiety and food intake, as well as provide potentially important clinical treatment strategies. The release of GI hormones in response to meal stimuli plays an important role in the regulation of body weight homeostasis. The neural pathways interconnecting gut signaling of satiety to the brain in response to nutrient intake are regulated by neuropeptides and GI hormones.

The investigators have a long history in the study of GI hormones. In the current application, the investigators plan to elucidate the impact of a high protein diet on the profile of gut hormones released postprandially in obese subjects and the underlying changes at the neuronal (vagal afferent) level that take place in response to a high protein diet in a relevant experimental model.

Understanding the regulatory mechanisms involved in satiety will provide clues for existing and novel forms of therapies. Studies may also provide insight into underlying mechanisms responsible for weight loss induced by gastroplasty and bariatric procedure used for the treatment of obesity.

The study design is a three-group randomized, controlled study. This randomized controlled study lasting 24-30 months will assign approximately 198 volunteer subjects (ages 30, BMI 27-40 kg/m2) (66 subjects each) to the following three groups who will adhere to diets with the same number of calories:

1. Very high protein diet group based on 1.4 gram of protein per pound of lean body mass,

2. High protein diet group based on 1 gram of protein per pound of lean body mass, and

3. Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories.

All participants will meet with a Registered Dietitian (who it is anticipated will join the research study team), to assist them with their diet efforts in all the arms.

In the study, the percent energy from fat will be held constant at 30% and the differences in the diets relate only to the protein and carbohydrate contents (35% protein and 35% carbohydrate, 25% protein and 45% carbohydrate, and 12.5% protein and 57.5% carbohydrate respectively).

We will assess the efficacy of a high protein diet on satiety and pattern of postprandial gut hormone in obese patients. All the subjects will be followed by a dietitian and determination of circulating gut hormone and biochemical assays will be performed.


Recruitment information / eligibility

Status Recruiting
Enrollment 198
Est. completion date December 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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, alanine transaminase (ALT), alanine transaminase (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;

- Thyroid-stimulating hormone (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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
United States VA Greater Los Angeles Healthcare System, West Los Angeles, CA West Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

Stengel A, Goebel-Stengel M, Wang L, Hu E, Karasawa H, Pisegna JR, Taché Y. High-protein diet selectively reduces fat mass and improves glucose tolerance in Western-type diet-induced obese rats. Am J Physiol Regul Integr Comp Physiol. 2013 Sep 15;305(6):R — View Citation

Vu JP, Goyal D, Luong L, Oh S, Sandhu R, Norris J, Parsons W, Pisegna JR, Germano PM. PACAP intraperitoneal treatment suppresses appetite and food intake via PAC1 receptor in mice by inhibiting ghrelin and increasing GLP-1 and leptin. Am J Physiol Gastroi — View Citation

Wang L, Jacobs JP, Lagishetty V, Yuan PQ, Wu SV, Million M, Reeve JR Jr, Pisegna JR, Taché Y. High-protein diet promotes sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity in rats. Am — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. High-protein diet promotes sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity 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.
Secondary 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 High-protein diet promotes sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity The outcome of efficacy is measured at Day 1 Baseline and at monthly visits during the 12 month study period for each subject.
Secondary Safety variables: incidence, severity and duration of adverse events, vital signs, concomitant medications and physical examination results. High-protein diet promotes sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity 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.
Secondary Improvement in NAFLD Fibrosis Score Patients enrolled with a history of NAFLD will be assessed for improvement in NAFLD Fibrosis scoring index and other imaging parameters if performed as standard clinical care. 1 year
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