Resistance Exercise and Protein During Weight Loss (RIDE)

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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Starvation
• Intervention / Treatment: Other: Energy Balance; Dietary supplement: Post-Exercise Carbohydrate; Dietary supplement: Calcium and Vitamin D; Other: Caloric Restriction; Dietary supplement: Post-Exercise Protein

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68583
      • Sports and Exercise Nutrition Laboratory, Department of Nutrition and Health Sciences, Ruth Leverton Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Energy Balance; 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; Participants will consume 40 kcal/kg FFM/day.; Dietary supplement: Post-Exercise Carbohydrate; Participants will ingest 30 g of carbohydrate following exercise.; Dietary supplement: Calcium and Vitamin D; Participants will be supplied Calcium and Vitamin D supplements throughout the study period matched to the CON condition.
Active Comparator: Caloric Restriction and CHO Supp; 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.	Dietary supplement: Post-Exercise Carbohydrate; Participants will ingest 30 g of carbohydrate following exercise.; Dietary supplement: Calcium and Vitamin D; Participants will be supplied Calcium and Vitamin D supplements throughout the study period matched to the CON condition.; Other: Caloric Restriction; Participants will consume 15 kcal/kg FFM/day.
Experimental: Caloric Restriction and PRO Supp; 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.	Dietary supplement: Calcium and Vitamin D; Participants will be supplied Calcium and Vitamin D supplements throughout the study period matched to the CON condition.; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Nebraska Lincoln
• Investigators: Principal Investigator: Karsten Koehler, University of Nebraska Lincoln

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Body Weight Changes; Weight Loss; Body Weight; Starvation; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium
• Other Study ID Numbers: 17933

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No