Protein Supplementation and Fat Mass Loss
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|ClinicalTrials.gov Identifier: NCT03678701|
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : September 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity High Body Fat||Dietary Supplement: Pre-meal 100% whey protein intake||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Protein Supplementation on Fat Mass Loss in Free Living Individuals With Overweight and Obesity - A Randomized Controlled Trial|
|Estimated Study Start Date :||September 24, 2018|
|Estimated Primary Completion Date :||May 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
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
- 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.
- Group differences in change in body weight [ Time Frame: Baseline, day 1, end of week 6, and at end of week 12 ]Body weight will be measured without shoes, in light clothing, using a digital Omron Scale and 1 kg will be subtracted for clothing.
- Group differences in change in body lean mass [ Time Frame: Baseline, end of 6th week and end of 12th week of intervention period ]Lean 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 lean mass from baseline to post treatment.
- 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.
- 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.
- 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.
- 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.
- Group differences in changes in grip strength [ Time Frame: Baseline, and and after the 6th and 12th week of intervention. ]Grip strength will be measured using the Lafayette Hand Grip Dynamometer
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): NCT03678701
|United States, Texas|
|Texas Tech University||Recruiting|
|Lubbock, Texas, United States, 79409|
|Contact: Emily J Dhurandhar, PhD 8068346556 email@example.com|
|Sub-Investigator: Nadeeja N Wijayatunga, MBBS, MPhil, PhD|
|Principal Investigator: Emily J Dhurandhar, PhD|
|Sub-Investigator: Nikhil Dhurandhar, PhD|
|Sub-Investigator: Youngdeok Kim, PhD|
|Sub-Investigator: Grant Tinsley, PhD|