CompletedNCT03600311RIDEUpdated Jun 12, 2019

Resistance Exercise and Protein During Weight Loss

An interventional study of Caloric Restriction and Post-Exercise Protein in Weight Loss and Starvation, sponsored by University of Nebraska Lincoln. Completed at 1 site in United States. Open to participants aged 19 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-12.

Sponsored by University of Nebraska Lincoln · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 17
Allocation: Randomized
Ages: 19 Years to 30 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Weight Loss
Starvation

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In context

Weight Loss

1,827 studies on the registry are indexed under Weight Loss; 290 are open to participants now.

This study's enrollment of 17 is below the median of 73 across 1,546 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

University of Nebraska Lincoln is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 30 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 17 participants (actual)

Study arms

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 · Dietary Supplement: Post-Exercise Carbohydrate · Dietary Supplement: Calcium and Vitamin D
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.
Other: Caloric Restriction · Dietary Supplement: Post-Exercise Carbohydrate · Dietary Supplement: Calcium and Vitamin D
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.
Other: Caloric Restriction · Dietary Supplement: Post-Exercise Protein · Dietary Supplement: Calcium and Vitamin D

Interventions

OtherCaloric Restriction
Participants will consume 15 kcal/kg FFM/day.
Dietary supplementPost-Exercise Protein
Participants will ingest 30 g of protein following exercise.
OtherEnergy Balance
Participants will consume 40 kcal/kg FFM/day.
Dietary supplementPost-Exercise Carbohydrate
Participants will ingest 30 g of carbohydrate following exercise.
Dietary supplementCalcium and Vitamin D
Drug pages: Calcium · Vitamin D
Participants will be supplied Calcium and Vitamin D supplements throughout the study period matched to the CON condition.

What researchers measure

Primary outcomes

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

Secondary outcomes

Change in Body Weight (kg)
Measured via Stadiometer
Time frame: Baseline and Day 4
Change in Body Fat Percentage (%)
Measured via DXA and BIA
Time frame: Baseline and Day 4
Change in Perceived Hunger (mm or %)
Measured on Visual Analog Scale within Survey
Time frame: Baseline and Day 4

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2018 to primary completion in May 2019, 8 months.

Of 683 non-industry interventional studies with no phase under Weight Loss, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's 8 months is below that.

Counting every sponsor, half of 738 studies reached it within 22 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 9, 2018
First posted: Jul 26, 2018
StartActual: Aug 31, 2018
Primary completionActual: May 1, 2019
CompletionActual: May 31, 2019
Last update: Jun 12, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03600311
Lead sponsor: University of Nebraska Lincoln
Responsible party: Sponsor
First posted: Jul 26, 2018
Start date: Aug 31, 2018
Primary completion: May 1, 2019
Completion: May 31, 2019
Last update: Jun 12, 2019

Study contacts

Karsten Koehler

principal investigator · University of Nebraska Lincoln

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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