Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03600311
Other study ID # 17933
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Active, not recruiting NCT04420936 - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program N/A
Terminated NCT03316105 - Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers N/A
Completed NCT03700736 - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups N/A
Active, not recruiting NCT04353726 - Knowledge-based Dietary Weight Management. N/A
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03377244 - Healthy Body Healthy Souls in the Marshallese Population N/A
Completed NCT02877004 - LLLT for Reducing Waste Circumference and Weight N/A
Active, not recruiting NCT04327141 - Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women N/A
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Recruiting NCT05249465 - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention N/A
Recruiting NCT05942326 - Sleep Goal-focused Online Access to Lifestyle Support N/A
Completed NCT00535600 - Effects of Bariatric Surgery on Insulin
Not yet recruiting NCT03601273 - Bariatric Embolization Trial for the Obese Nonsurgical Phase 1
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT02945410 - Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity N/A
Completed NCT03139760 - POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT02948517 - Time Restricted Feeding for Weight Loss and Cardio-protection N/A
Recruiting NCT02559479 - A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes N/A