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

NCT03515889 | Completed DMC

• 1 other identifier: 2017-917
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Change in weight

  Change in weight at follow-up

  Baseline and three months

Secondary Outcomes (9)

• Body Composition

  Baseline and three months

• Body Composition

  Baseline and three months

• Lipid parameters

  Baseline and three months

• Fasting glucose

  Baseline and three months

• Continuously measured glucose

  Baseline and three months

Study Arms (2)

Ideal Protein Weight Loss Protocol

EXPERIMENTAL

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

Standard Weight Loss

ACTIVE COMPARATOR

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

Interventions

Ideal Protein Weight Loss Method BEHAVIORAL

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).

Ideal Protein Weight Loss Protocol

Standard Weight Loss BEHAVIORAL

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).

Standard Weight Loss

Eligibility Criteria

• Age: 22 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• All potential participants must be willing and able to provide informed consent.

You may not qualify if:

• History of any bariatric surgery, including gastric banding, Roux-en-Y and duodenal switch with biliopancreatic diversion procedures, vertical banded gastroplasty, etc.
• Currently on a diet or using prescription weight loss medications, and/or experienced weight loss \>15 pounds within 6 months of study entry.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Tulane University: lead
• Ideal Protein: collaborator

Study Sites (1)

Bogalusa Heart Study Clinic

Bogalusa, Louisiana, 70427, United States

Location

Related Publications (1)

• Fernandez CA, Potts K, Bazzano LA. Effect of ideal protein versus low-fat diet for weight loss: A randomized controlled trial. Obes Sci Pract. 2021 Oct 15;8(3):299-307. doi: 10.1002/osp4.567. eCollection 2022 Jun.

  PMID: 35664249 RESULT

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Epidemiology

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 4, 2018
• Study Start: May 23, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)