Protein Supplementation and Fat Mass Loss

November 22, 2019 updated by: Emily Dhurandhar, Texas Tech University

Effects of Protein Supplementation on Fat Mass Loss in Free Living Individuals With Overweight and Obesity - A Randomized Controlled Trial

Investigators examined the associations between whey protein supplementation before meals with energy balance and body composition.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Increase intake of dietary protein has been shown to have a role in weight loss and weight management since it affects satiety, thermogenesis, energy efficiency, and body composition. However, the effects of long-term protein supplementation on body fat mass in free living individuals with overweight and obesity are not known. This knowledge is important because people are more likely to take a protein supplement and expect to achieve fat loss without any other life style modification. Our research question is, whether consumption of whey protein supplements prior to main meals will reduce body weight and body fat without other intentional behavioral changes. We hypothesize that, addition of a 30g protein drink (100% whey isolate) 1 hour before lunch and dinner would promote negative energy balance, leading to body fat reduction in free living individuals with overweight and obesity in the absence of any other lifestyle changes. Our specific aims are: (1) To determine the impact of long-term protein supplementation on energy expenditure and body composition; (2) To determine the impact of long-term protein supplementation in free living condition on satiety and hunger; and (3) To determine the impact of long-term protein supplementation on physical activity and muscle strength. To test our hypothesis, we will conduct a 12-week, two parallel group randomized controlled trial with an additional baseline week. The intervention group will be advised to consume 30g whey protein shake 1 hour before lunch and before dinner for 12 weeks while the control group will not consume protein shakes. Both groups will continue usual dietary habits and physical activity. We will measure food intake using 3-day dietary records pre-intervention, and during intervention at week 7, and 12. Physical activity will be monitored using a hip worn accelerometer pre-intervention and during 6th week of intervention. Measurements taken pre-intervention, at the end of 6th week and at the end of 12th week include body weight, body composition using dual energy x-ray absorptiometry and bioelectrical impedance analysis. Resting metabolic rate will be measured using indirect calorimetry pre- and post-intervention. Between-meal satiety and hunger will be measured using 100 mm Visual Analog Scales at 6am, 11am, I hour after lunch, 6pm, 1 hour after dinner at baseline, day 14th, 43th and 83rd.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79409
        • Recruiting
        • Texas Tech University
        • Contact:
        • Sub-Investigator:
          • Nadeeja N Wijayatunga, MBBS, PhD
        • Principal Investigator:
          • Emily J Dhurandhar, PhD
        • Sub-Investigator:
          • Nikhil Dhurandhar, PhD
        • Sub-Investigator:
          • Youngdeok Kim, PhD
        • Sub-Investigator:
          • Grant Tinsley, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 19-55 years
  • Body mass index more than or equal to 23 kg/m2 for Asians and more than or equal to 25 kg/m2 for other ethnic groups up to 40 kg/m2
  • Individuals who are able to speak, read and write in English

Exclusion Criteria:

  • Lactose intolerance
  • Food allergies to milk products
  • Religious affiliations that include specific food guidelines.
  • Participation in any weight-reduction program, weight-loss diet, or other special diet within the previous 3 months or planning to enroll in those within next 3 months
  • History of prior surgical procedure for weight control or planning to have one within next 3 months
  • Weight loss or gain of >5% of body weight in the past 6 months for any reason except post-partum weight loss.
  • Current smoker or quit smoking less than 6 months prior.

  • Any major disease, including:

    • Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).
    • Active or chronic infections, including self-reported HIV positivity and active tuberculosis.
    • Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease (e.g., coronary artery bypass, percutaneous transluminal coronary angioplasty) in the past 6 months; New York Heart Association Functional Class >2 with respect to congestive heart failure; stroke or transient ischemic attack in the past 6 months.
    • Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
    • Active renal disease.
    • Lung disease: chronic obstructive airway disease requiring use of oxygen.
    • Diagnosed diabetes (type 1 or 2).
    • On medication that may not be absorbed while on whey protein supplements: Levodopa, alendronate and Albendazole
    • Diagnosed hypertension or resting blood pressure more than 140/90
    • Uncompensated or uncontrolled psychiatric disease (such as schizophrenia and bipolar disorder) that, in opinion of the investigators, would impede conduct of the trial or completion of procedures.
    • Zung Self-Rating Depression Scale score is >42 and Eating Attitudes Test score to ensure that our participants do not have symptoms of depression
    • History of or current eating disorders, or an Eating Attitudes Test (EAT-26) score >20
    • Conditions or behaviors likely to affect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent clinic staff; another household member is a participant or staff member in the trial; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away from participating clinics before trial completed; unable to walk 0.25 mile in 10 minutes.
    • Currently taking antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months.
    • A recent or ongoing problem with drug abuse or addiction.
    • Excessive alcohol intake, either acute or chronic, defined as any one of the following: 1) average consumption of 3 or more alcohol containing beverages daily; 2) consumption of 7 or more alcoholic beverages within a 24-hr period in the past 12 months; or 3) other evidence available to clinic staff.
    • Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
  • Currently taking medication that suppresses or stimulates appetite or that affects body weight, including oral anti-diabetic medications.
  • Anyone currently taking statins
  • Pregnancy and childbearing: currently pregnant or less than 3 months post partum; currently nursing or within 6 weeks of having completed nursing; pregnancy anticipated during study; unwilling to report possible or confirmed pregnancies promptly during the course of the trial; unwilling to take adequate contraceptive measures if potentially fertile.
  • Not willing to stop taking protein supplements for the next 3 months, if selected for the control
  • Engaged in aerobic physical activity (brisk walking, jogging, and running) for more than 30 minutes per day for 5 times per week or performing any resistance training
  • Ratings for the supplement taste is 5 or more on a Likert Scale from 1= "Dislike extremely" to 9= "Like extremely" after tasting the protein shake
  • Any other conditions which in opinion of the investigators that would adversely affect the conduct of the trial will also be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Protein group
The protein group will consume 30g of 100% whey protein shake 1 hour before lunch and before dinner, for 12 weeks
Dietary supplement: Pre-meal 100% whey protein intake
Participants in the protein group will be provided 100% whey protein powder and will be advised to drink 30g of protein dissolved in 237ml (8oz) of water, one hour before lunch and dinner.
No Intervention: Control group
Control group will not consume any protein supplements. They will continue the usual feeding habits

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Group differences in change in body fat mass
Time Frame: Baseline, end of 6th week and end of 12th week of intervention period
Fat mass will be measured using a Lunar Dual X-Ray Absorptiometry Scanner (GE Medical Systems) and the Imp SFB7 BIS (ImpediMed Ltd, Australia) at baseline, and at end of the treatment period. The outcome to be compared between groups will be change in percent fat mass from baseline to post treatment.
Baseline, end of 6th week and end of 12th week of intervention period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Group differences in change in physical activity energy expenditure
Time Frame: Baseline and week 7 of the intervention period
Participants will be instructed to wear a tri-axial accelerometer (AntiGraph GT3X+, Pensacola, FL) on their right hip during waking hours for 7 days. Accelerations will be summed over 1 minute epochs and 60 minutes will be used to determine non-wear time. Using the Freedson VM3 Combination algorithm (42) in Actilife v6.13.3, accelerometer data will be processed to yield estimates of daily and weekly PAEE for each treatment period. Participants will be asked to wear an accelerometer and keep a log of their daily activities that include planned exercise for seven days during week 3 of the protocol.
Baseline and week 7 of the intervention period
Group differences in changes in meal satiety and hunger
Time Frame: Baseline, day 14, 43 and 83 of intervention period
Satiety and hunger will be measured using 100 mm Visual Analog Scales anchored by "not at all" to "extremely" in response to questions about hunger, fullness, desire to eat, and ability to eat more just before consuming before and after meals. Participants will be asked to fill out these questionnaires at 6am, 11am, I hour after lunch, 6pm, 1 hour after dinner.
Baseline, day 14, 43 and 83 of intervention period
Group differences in change in resting Metabolic Rate
Time Frame: Baseline, and at end 12 weeks of intervention period
Resting metabolic rate will be measured by indirect calorimetry using the Cosmed's FitMateTM (COSMED, Italy) metabolic system using a canopy dilution set-up.
Baseline, and at end 12 weeks of intervention period
Group differences in changes in food intake
Time Frame: Baseline, at week 7, and at week 12 of intervention period
Food intake will be studied over 3 days (one weekend and 2 weekdays) Dietary data will be used to calculate energy intake and macronutrient distribution of participant diets using the USDA nutrient database.
Baseline, at week 7, and at week 12 of intervention period
Group differences in changes in grip strength
Time Frame: Baseline and after the 6th and 12th week of intervention.
Grip strength will be measured using the Lafayette Hand Grip Dynamometer
Baseline and after the 6th and 12th week of intervention.
Group differences in change in lean mass
Time Frame: Baseline and after 6th and 12th week of intervention
Lean mass will be measured using a Lunar Dual X-Ray Absorptiometry Scanner
Baseline and after 6th and 12th week of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Tech University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emily J (806)834-6556, Texas Tech University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB2018-126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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