ObesityNCT03678701
Protein Supplementation and Fat Mass Loss
A study testing Pre-meal 100% whey protein intake in people with Obesity, run by Texas Tech University at 1 site in United States.
Trial summary
Investigators examined the associations between whey protein supplementation before meals with energy balance and body composition. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Pre-meal 100% whey protein intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 32Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Tech University
Lubbock, Texas, 79409
Emily J Dhurandhar, PhD, 806-834-6556, emily.dhurandhar@ttu.edu
Nadeeja N Wijayatunga, MBBS, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Pre-meal 100% whey protein intake
- Keywords
- whey protein, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-meal 100% whey protein intakeDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Protein group | Experimental | The protein group will consume 30g of 100% whey protein shake 1 hour before lunch and before dinner, for 12 weeks Receives: Dietary Supplement: Pre-meal 100% whey protein intake |
| Control group | No intervention | Control group will not consume any protein supplements. They will continue the usual feeding habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group differences in change in body fat mass
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.
Measured: Baseline, end of 6th week and end of 12th week of intervention period
Secondary outcomes (6)
Group differences in change in physical activity energy expenditure
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.
Measured: Baseline and week 7 of the intervention period
Group differences in changes in meal satiety and hunger
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.
Measured: Baseline, day 14, 43 and 83 of intervention period
Group differences in change in resting Metabolic Rate
Resting metabolic rate will be measured by indirect calorimetry using the Cosmed's FitMateTM (COSMED, Italy) metabolic system using a canopy dilution set-up.
Measured: Baseline, and at end 12 weeks of intervention period
Group differences in changes in food intake
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.
Measured: Baseline, at week 7, and at week 12 of intervention period
Group differences in changes in grip strength
Grip strength will be measured using the Lafayette Hand Grip Dynamometer
Measured: Baseline and after the 6th and 12th week of intervention.
Group differences in change in lean mass
Lean mass will be measured using a Lunar Dual X-Ray Absorptiometry Scanner
Measured: Baseline and after 6th and 12th week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start1 Oct 2018
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Dhurandhar, Texas Tech University
- Investigators
- Emily J (806)834-6556, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678701
- Sponsor's protocol ID
- IRB2018-126
- Status last verified
- Nov 2019
- First submitted
- 18 Sep 2018
- Last updated
- 26 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Protein Supplementation on Fat Mass Loss in Free Living Individuals With Overweight and Obesity - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03678701
- Acronym / sponsor ID
- IRB2018-126
- Conditions
- Obesity
- Keywords
- whey protein, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators examined the associations between whey protein supplementation before meals with energy balance and body composition.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein group | Experimental | Dietary Supplement: Pre-meal 100% whey protein intakeThe protein group will consume 30g of 100% whey protein shake 1 hour before lunch and before dinner, for 12 weeks |
| Control group | No intervention | –Control group will not consume any protein supplements. They will continue the usual feeding habits |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-meal 100% whey protein intakeParticipants 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. | Dietary supplement | Protein group |
Primary outcome
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.
6 secondary outcomes
Group differences in change in physical activity energy expenditure
Time frame: 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
Group differences in change in resting Metabolic Rate
Time frame: 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
Group differences in changes in grip strength
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily J (806)834-6556 principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-meal 100% whey protein intake in people with Obesity, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily J Dhurandhar, PhD (8068346556, emily.dhurandhar@ttu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group differences in change in body fat mass (time frame: Baseline, end of 6th week and end of 12th week of intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.