Recruiting

Protein Supplementation

Sponsor:

Texas Tech University

Code:

NCT03678701

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 19 - 55

Healthy Volunteers: Accepted

Interventions

Pre-meal 100% whey protein intake

Study Details

Brief summary:

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

Conditions

Obesity

Study ID

NCT03678701

Start date

Oct 1, 2018

Status verified date

Nov, 2019

Completion date

Feb 28, 2020

Anticipated

Primary completion date

Feb 28, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Protein group

The protein group will consume 30g of 100% whey protein shake 1 hour before lunch and before dinner, for 12 weeks

no intervention: Control group

Control group will not consume any protein supplements. They will continue the usual feeding habits

Interventions

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.

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 ]

Central Contacts and Locations

Central contacts

Emily J Dhurandhar, PhD

8068346556emily.dhurandhar@ttu.edu

Locations

Texas Tech University

Recruiting

Lubbock, Texas, United States, 79409

Contacts

Emily J Dhurandhar, PhD

806-834-6556emily.dhurandhar@ttu.edu

Principal Investigator:

Emily J Dhurandhar, PhD

More Information

Sponsor

Texas Tech University

Last update posted

Nov 26, 2019

Last verified

Nov, 2019

Keywords

  • whey protein
  • Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Texas Tech University on 2019-11-26.