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Resistance Exercise and Protein During Weight Loss (RIDE)

Primary Purpose

Weight Loss, Starvation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caloric Restriction
Post-Exercise Protein
Energy Balance
Post-Exercise Carbohydrate
Calcium and Vitamin D
Sponsored by
University of Nebraska Lincoln
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Weight Loss

Eligibility Criteria

19 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sports and Exercise Nutrition Laboratory, Department of Nutrition and Health Sciences, Ruth Leverton Hall

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Energy Balance

Caloric Restriction and CHO Supp

Caloric Restriction and PRO Supp

Arm Description

Participants will be in energy balance and consume 1.2 g/kg BW protein. They will be provided 30 g of maltodextrin following exercise.

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.

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.

Outcomes

Primary Outcome Measures

Change in Serum [IGF-1] (ng/mL)
Measured via ELISA
Change in Serum [GH] (pg/mL)
Measured via ELISA
Change in Serum [IGFBP-3] (ng/mL)
Measured via ELISA
Change in Serum [P1NP] (pg/mL)
Measured via ELISA
Change in Serum [CTX] (ng/mL)
Measured via ELISA
Change in Serum [Sclerostin] (pmol/L)
Measured via ELISA

Secondary Outcome Measures

Change in Body Weight (kg)
Measured via Stadiometer
Change in Body Fat Percentage (%)
Measured via DXA and BIA
Change in Perceived Hunger (mm or %)
Measured on Visual Analog Scale within Survey

Full Information

First Posted
July 9, 2018
Last Updated
June 10, 2019
Sponsor
University of Nebraska Lincoln
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1. Study Identification

Unique Protocol Identification Number
NCT03600311
Brief Title
Resistance Exercise and Protein During Weight Loss
Acronym
RIDE
Official Title
Using Resistance Exercise and Protein Consumption to Protect Bone Health During Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 31, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska Lincoln

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Starvation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Energy Balance
Arm Type
Placebo Comparator
Arm Description
Participants will be in energy balance and consume 1.2 g/kg BW protein. They will be provided 30 g of maltodextrin following exercise.
Arm Title
Caloric Restriction and CHO Supp
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Caloric Restriction and PRO Supp
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Caloric Restriction
Intervention Description
Participants will consume 15 kcal/kg FFM/day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Post-Exercise Protein
Intervention Description
Participants will ingest 30 g of protein following exercise.
Intervention Type
Other
Intervention Name(s)
Energy Balance
Intervention Description
Participants will consume 40 kcal/kg FFM/day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Post-Exercise Carbohydrate
Intervention Description
Participants will ingest 30 g of carbohydrate following exercise.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium and Vitamin D
Intervention Description
Participants will be supplied Calcium and Vitamin D supplements throughout the study period matched to the CON condition.
Primary Outcome Measure Information:
Title
Change in Serum [IGF-1] (ng/mL)
Description
Measured via ELISA
Time Frame
Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Title
Change in Serum [GH] (pg/mL)
Description
Measured via ELISA
Time Frame
Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Title
Change in Serum [IGFBP-3] (ng/mL)
Description
Measured via ELISA
Time Frame
Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Title
Change in Serum [P1NP] (pg/mL)
Description
Measured via ELISA
Time Frame
Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Title
Change in Serum [CTX] (ng/mL)
Description
Measured via ELISA
Time Frame
Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Title
Change in Serum [Sclerostin] (pmol/L)
Description
Measured via ELISA
Time Frame
Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Secondary Outcome Measure Information:
Title
Change in Body Weight (kg)
Description
Measured via Stadiometer
Time Frame
Baseline and Day 4
Title
Change in Body Fat Percentage (%)
Description
Measured via DXA and BIA
Time Frame
Baseline and Day 4
Title
Change in Perceived Hunger (mm or %)
Description
Measured on Visual Analog Scale within Survey
Time Frame
Baseline and Day 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Koehler
Organizational Affiliation
University of Nebraska Lincoln
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sports and Exercise Nutrition Laboratory, Department of Nutrition and Health Sciences, Ruth Leverton Hall
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68583
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Resistance Exercise and Protein During Weight Loss

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