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A Trial of the Ideal Protein System Versus Low Fat Diet for Weight Loss (RENEWAL)

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ClinicalTrials.gov Identifier: NCT03515889
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
Ideal Protein
Information provided by (Responsible Party):
Lydia A. Bazzano, Tulane University

Brief Summary:
This study will examine whether, compared to a standard, low-fat, calorie-restricted diet intervention, the clinic-supported Ideal Protein weight loss method will result in greater weight loss and improvement in cardiometabolic risk factors over 3 months among obese adults with cardiovascular disease (CVD) risk factors.

Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: Ideal Protein Weight Loss Method Behavioral: Standard Weight Loss Not Applicable

Detailed Description:
Restricting total calorie intake is emphasized in the 2013 American Heart Association/ American College of Cardiology/ The Obesity Society Guideline (AHA/ACC/TOS) for the Management of Overweight and Obesity in Adults for its effectiveness at reducing body weight and decreasing cardiometabolic risk factors. An implication of this focus on total quantity of calories consumed is that macronutrient composition of dietary intake and its effects on the hormonal milieu that regulates adipose accumulation in the human body do not play a significant role in weight loss. Such recommendations and the results of limited previous studies have led to the advice that all weight loss diets regardless of macronutrient composition will produce the same degree of weight loss if adherence to the diet is similar. In contrast, our previous studies have shown that despite comparable adherence to dietary goals, participants losing weight on a moderately carbohydrate-restricted, adequate protein regimen have improved cardiometabolic indicators as compared to those restricting fat. The RENEWAL trial will provide unique data on the efficacy of the Ideal Protein method (moderate carbohydrate restriction and adequate protein) for weight loss and improvement in cardiometabolic risk factors. The interventions will include a significant proportion of African-Americans, a group with very high rates of obesity which is often under-represented in trials examining the effects of weight loss diets. Findings from this trial may offer new evidence for the recommendation of specific macronutrient and behavioral approaches to the reduction of cardiometabolic risk factors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants (n=192) with BMI ≥30 and ≤49 will be randomized to one of two parallel study arms: Group A: Ideal Protein Weight Loss Intervention; Group B: Standard Low-Fat, Low-Calorie, Guideline-based Weight Loss Intervention. Participants will undergo baseline testing, and if eligible, will be randomly assigned to study group, undergo three months of their assigned study intervention, and clinical testing at baseline, 6, and 12 weeks.
Masking: Single (Outcomes Assessor)
Masking Description: Throughout the study every effort will be made to ensure objective and blinded assessments of outcomes. Although participants will be told of their treatment assignment they will not be provided details about the intervention techniques of the other treatment groups. Focus will instead be maintained on the group to which they are assigned. Staff who obtain and record participant assessments at the clinical assessments will not be informed of the participant's treatment assignment and will not participate in the delivery of the study interventions.
Primary Purpose: Other
Official Title: A Trial of the Ideal Protein System Versus Low Fat Diet for Weight Loss
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ideal Protein Weight Loss Protocol
This arm will follow the Ideal Protein method as documented in the Ideal Protein Clinic Manual and in the Ideal Protein Coaches Manual.
Behavioral: Ideal Protein Weight Loss Method

An initial visit will take place in which each participant assigned to the experimental group will complete a health profile questionnaire.The Ideal Protein method will be explained and the participant will be weighed, measured and given diet related informational materials. A staff member will assist the participant with the selection of foods and snacks to ensure adequate quantity for the week. Weekly follow-up visits of 15 minutes duration will be implemented with a telephone follow-up occurring during the first 4 days after the initial appointment.

For 12 weeks Ideal Protein foods that are of the appropriate composition and quantity will be provided at weekly or twice monthly intervals as included in the diet. Dietary supplements will be provided (multivitamin, calcium/magnesium, potassium, omega-3, and Ideal Salt substitute).


Active Comparator: Standard Weight Loss
This arm utilizes evidence-based, low fat, low calorie strategies that have been shown to be effective for long-term weight loss and weight loss maintenance.
Behavioral: Standard Weight Loss

This arm utilizes evidence-based strategies that have been shown to be effective for long-term weight loss and weight loss maintenance (including behavioral techniques, diet modification, and social support) consistent with the 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults. Participants in this arm will have an initial one hour consultation with a trained interventionist, where the fat goal and calorie restriction goal are explained.

For 12 weeks low-fat reduced calorie foods that are of appropriate composition and quantity will be provided at weekly or twice monthly intervals as included in the diet. Dietary supplements will be provided (multivitamin, calcium/magnesium, potassium, omega-3, and Ideal Salt substitute).





Primary Outcome Measures :
  1. Change in weight [ Time Frame: Baseline and three months ]
    Change in weight at follow-up


Secondary Outcome Measures :
  1. Body Composition [ Time Frame: Baseline and three months ]
    Change in waist and hip circumference

  2. Body Composition [ Time Frame: Baseline and three months ]
    Change in lean and fat mass

  3. Lipid parameters [ Time Frame: Baseline and three months ]
    Change in lipid parameters

  4. Fasting glucose [ Time Frame: Baseline and three months ]
    Change in fasting glucose

  5. Continuously measured glucose [ Time Frame: Baseline and three months ]
    Change in continuously measured glucose

  6. Systolic Blood Pressure [ Time Frame: Baseline and three months ]
    Change in systolic blood pressure

  7. Diastolic Blood Pressure [ Time Frame: Baseline and three months ]
    Change in systolic blood pressure

  8. Appetite [ Time Frame: Baseline and three months ]
    Change in appetite as measured by self-report questionnaires

  9. Satiety [ Time Frame: Baseline and three months ]
    Change in satiety as measured by self-report questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. All participants will be obese. Obesity will be defined as BMI ≥ 30 kg/m2 at the baseline study visit. An upper limit of BMI will be set at 49 kg/m2 to include a wide range of obese men and women with a reasonable probability of losing weight in the context of a dietary behavioral intervention.
  2. Participants must have at least one co-morbid condition that increases risk of cardiovascular disease (history of CVD, type II diabetes mellitus, fasting plasma glucose>100 mg/dL, metabolic syndrome as defined by ATP III criteria, hypertension, hyperlipidemia, WC>40 in among men or >35 in among women).
  3. All potential participants must be willing and able to provide informed consent.

Exclusion Criteria:

  1. History of any bariatric surgery, including gastric banding, Roux-en-Y and duodenal switch with biliopancreatic diversion procedures, vertical banded gastroplasty, etc.
  2. Currently on a diet or using prescription weight loss medications, and/or experienced weight loss >15 pounds within 6 months of study entry.
  3. Regular use of alcohol >3 beverages per day or 21 beverages per week (1 standard beverage = 350 mL of 5% alcohol beer, or 150 mL of 12% wine, or 45 mL of 80-proof distilled spirits), amphetamines, cocaine, heroin, or marijuana over past 6 months.
  4. Past or present history of eating disorder (including anorexia, bulimia or binge eating disorder) or severe/untreated psychiatric illness which may affect participation in study interventions.
  5. Strict dietary concerns (e.g., vegetarian or kosher diet, significant nut or multiple food allergies). This is an exclusion because participant may not be able to fully participate in the intervention.
  6. For women, current pregnancy or breastfeeding or plans to become pregnant during the study period. This is an exclusion because weight loss is contraindicated during pregnancy.
  7. Plans to move out of the study area (>1 hour from study site) or difficulty to come to the study site. This is an exclusion because these conditions may interfere with the ability to fully participate in and complete the study.
  8. Participation of another household member in the study; employees or persons living with employees of the study. This is an exclusion because randomization of more than one participant in a household to differing diets may cause conflict within a household and limit engagement in the intervention. Employees of the study are excluded due to potential conflicts of interest and knowledge of study assignments.
  9. Participation in other lifestyle intervention trials currently. This is an exclusion because interference with ability to determine whether study interventions are responsible for outcomes.
  10. Medical condition in which a carbohydrate restricted diet may not be advised (eg. severe renal impairment, osteoporosis, untreated thyroid disease, frequent gout attacks, Type I diabetes). This is an exclusion because participant may not be able to fully participate in the intervention.
  11. Hospitalization for a CVD event such as myocardial infarction, stroke, TIA, coronary revascularization, heart failure, peripheral artery disease, or unstable angina within the last 6 weeks or unstable coronary artery disease. Major new medical illness including renal disease requiring dialysis, a life-threatening illness with life expectancy less than six months, or cancer requiring chemotherapy or radiation treatment in the previous two years. [NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent.] This is an exclusion because these conditions may interfere with the ability to fully participate in and complete the study.
  12. MMSE score < 23 or dementia. This is an exclusion because it may interfere with the ability to fully participate in the study.
  13. Non-English speaking, a visual impairment or a hearing impairment that interferes with study participation. This is an exclusion criterion because these potential participants may not be able to participate fully in the intervention.
  14. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515889


Contacts
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Contact: Lydia Bazzano, MD, PhD 5049887323 lbazzano@tulane.edu

Locations
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United States, Louisiana
Bogalusa Heart Study Clinic Recruiting
Bogalusa, Louisiana, United States, 70427
Contact: Jeanna Dawes, RN    985-735-9861 ext 9    jdawes@tulane.edu   
Principal Investigator: Lydia A Bazzano, MD, PhD         
Sponsors and Collaborators
Tulane University
Ideal Protein

Publications:
Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102-38. doi: 10.1161/01.cir.0000437739.71477.ee. Epub 2013 Nov 12. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S139-40.

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Responsible Party: Lydia A. Bazzano, Associate Professor of Epidemiology, Tulane University
ClinicalTrials.gov Identifier: NCT03515889     History of Changes
Other Study ID Numbers: 2017-917
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes