Resistance Exercise and Protein During Weight Loss

Weight Loss Clinical Trial

— RIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600311
• Other study ID #: 17933
• Status: Completed
• Phase: N/A
• Start date: August 31, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: June 2019
• Source: University of Nebraska Lincoln
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 31, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Starvation
• Weight Loss

Intervention

Other:
• Caloric Restriction
Participants will consume 15 kcal/kg FFM/day.

Dietary Supplement:
• Post-Exercise Protein
Participants will ingest 30 g of protein following exercise.

Other:
• Energy Balance
Participants will consume 40 kcal/kg FFM/day.

Dietary Supplement:
• Post-Exercise Carbohydrate
Participants will ingest 30 g of carbohydrate following exercise.
• Calcium and Vitamin D
Participants will be supplied Calcium and Vitamin D supplements throughout the study period matched to the CON condition.

Locations

Country	Name	City	State
United States	Sports and Exercise Nutrition Laboratory, Department of Nutrition and Health Sciences, Ruth Leverton Hall	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska Lincoln

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum [IGF-1] (ng/mL)	Measured via ELISA	Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Primary	Change in Serum [GH] (pg/mL)	Measured via ELISA	Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Primary	Change in Serum [IGFBP-3] (ng/mL)	Measured via ELISA	Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Primary	Change in Serum [P1NP] (pg/mL)	Measured via ELISA	Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Primary	Change in Serum [CTX] (ng/mL)	Measured via ELISA	Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Primary	Change in Serum [Sclerostin] (pmol/L)	Measured via ELISA	Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Secondary	Change in Body Weight (kg)	Measured via Stadiometer	Baseline and Day 4
Secondary	Change in Body Fat Percentage (%)	Measured via DXA and BIA	Baseline and Day 4
Secondary	Change in Perceived Hunger (mm or %)	Measured on Visual Analog Scale within Survey	Baseline and Day 4