Resistance Exercise and Protein During Weight Loss

Study Overview
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Brief Summary
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The purpose of this study is to determine if post-exercise protein supplementation can rescue the anabolic response of muscle and bone to resistance exercise during caloric restriction.

Detailed Description
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Preliminary Testing Prior to the study start, participants will be weighed and body composition will be determined using bioimpedance analysis. Then participants will undergo a 5RM barbell back squat exercise testing procedure. Randomization Participants will proceed through each of the following conditions lasting 3 days: CON: Participants will be in energy balance and consume 1.2 g protein/kg BW/day. Participants will be provided 30 g maltodextrin post-exercise. CR+C: Participants will be restricted to 15 kcal/kg FFM/day and consume 1.2 g protein/kg BW/day. Participants will be provided 30 g maltodextrin post-exercise. CR+P: Participants will be restricted to 15 kcal/kg FFM/day and consume 1.2 g protein/kg BW/day. Participants will be provided 30 g whey protein post-exercise. Diet Prescription Dietary energy intake will be controlled using clinical products, maltodextrin and whey protein isolate to meet target energy intakes. Participants will receive calcium and Vitamin D supplementation throughout the study. Exercise Prescription Participants will perform one bout of 5 sets of 5 repetitions of barbell back squat exercise on the morning of Day 3 each condition. Additional exercise and intense physical activity will be prohibited. Assessments Body weight and composition (DXA + BIA), fasting blood draws for assessment of metabolic and anabolic hormones and questionnaires will be conducted before and after each condition. A 24-hour serial blood draw procedure will be conducted following each workout session on each Day 3. Washout Once a participant completes a study condition, participants will continue to take daily body weights at home for up to one week. Then participants will be required to wait one more week before completing their next condition during which they will resume regular diet and physical activity.

Official Title
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Using Resistance Exercise and Protein Consumption to Protect Bone Health During Weight Loss

Conditions
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Weight Loss, Starvation

Intervention / Treatment
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* Other: Caloric Restriction
* Dietary Supplement: Post-Exercise Protein
* Other: Energy Balance
* Dietary Supplement: Post-Exercise Carbohydrate
* Dietary Supplement: Calcium and Vitamin D


Participation Criteria
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Eligibility Criteria
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Baseline Inclusion Criteria: Weigh at least 110 lbs Weight-Stable (2.5 kg) within the past six months Height-Stable (< 0.25 inches) within the past year 3 years of resistance training experience Tested Inclusion Criteria: - <20% body fat (men) or <30% body fat (women) Exclusion Criteria: Lactose intolerant Pregnancy Taking interfering medications such as steroids, thyroid or growth hormones

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Energy Balance<br>Participants will be in energy balance and consume 1.2 g/kg BW protein. They will be provided 30 g of maltodextrin following exercise. | Other: Energy Balance<br>* Participants will consume 40 kcal/kg FFM/day.<br>Dietary Supplement: Post-Exercise Carbohydrate<br>* Participants will ingest 30 g of carbohydrate following exercise.<br>Dietary Supplement: Calcium and Vitamin D<br>* Participants will be supplied Calcium and Vitamin D supplements throughout the study period matched to the CON condition.<br>|
| Active Comparator: Caloric Restriction and CHO Supp<br>Participants will be calorie restricted to 15 kcal/kg FFM/day and consume 1.2 g/kg BW protein. They will be provided 30 g of maltodextrin following exercise. | Other: Caloric Restriction<br>* Participants will consume 15 kcal/kg FFM/day.<br>Dietary Supplement: Post-Exercise Carbohydrate<br>* Participants will ingest 30 g of carbohydrate following exercise.<br>Dietary Supplement: Calcium and Vitamin D<br>* Participants will be supplied Calcium and Vitamin D supplements throughout the study period matched to the CON condition.<br>|
| Experimental: Caloric Restriction and PRO Supp<br>Participants will be calorie restricted to 15 kcal/kg FFM/day and consume 1.2 g/kg BW protein. They will be provided 30 g of whey protein following exercise. | Other: Caloric Restriction<br>* Participants will consume 15 kcal/kg FFM/day.<br>Dietary Supplement: Post-Exercise Protein<br>* Participants will ingest 30 g of protein following exercise.<br>Dietary Supplement: Calcium and Vitamin D<br>* Participants will be supplied Calcium and Vitamin D supplements throughout the study period matched to the CON condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum [IGF-1] (ng/mL) | Measured via ELISA | Baseline, Pre-Exercise, 0-24 Hours Post-Exercise | 
| Change in Serum [GH] (pg/mL) | Measured via ELISA | Baseline, Pre-Exercise, 0-24 Hours Post-Exercise | 
| Change in Serum [IGFBP-3] (ng/mL) | Measured via ELISA | Baseline, Pre-Exercise, 0-24 Hours Post-Exercise | 
| Change in Serum [P1NP] (pg/mL) | Measured via ELISA | Baseline, Pre-Exercise, 0-24 Hours Post-Exercise | 
| Change in Serum [CTX] (ng/mL) | Measured via ELISA | Baseline, Pre-Exercise, 0-24 Hours Post-Exercise | 
| Change in Serum [Sclerostin] (pmol/L) | Measured via ELISA | Baseline, Pre-Exercise, 0-24 Hours Post-Exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight (kg) | Measured via Stadiometer | Baseline and Day 4 | 
| Change in Body Fat Percentage (%) | Measured via DXA and BIA | Baseline and Day 4 | 
| Change in Perceived Hunger (mm or %) | Measured on Visual Analog Scale within Survey | Baseline and Day 4 |