Weight LossRIDENCT03600311
Resistance Exercise and Protein During Weight Loss
A study testing Caloric Restriction, Post-Exercise Protein and Energy Balance in people with Weight Loss and Starvation, run by University of Nebraska Lincoln at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Starvation
- What is being tested?
- Caloric Restriction, Post-Exercise Protein and Energy Balance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Lactose intolerant
- Pregnancy
- Taking interfering medications such as steroids, thyroid or growth hormones
Trial locations and contacts
1 site in 1 country.
United States1 site
Sports and Exercise Nutrition Laboratory, Department of Nutrition and Health Sciences, Ruth Leverton Hall
Lincoln, Nebraska, 68583
About this study
Official title: 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.
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
- Weight Loss, Starvation
- Being tested
- Caloric Restriction, Post-Exercise Protein, Energy Balance, Post-Exercise Carbohydrate, Calcium and Vitamin D
- Medical subject headings
- Weight Loss, Starvation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric RestrictionOther
Participants will consume 15 kcal/kg FFM/day.
Post-Exercise ProteinDietary supplement
Participants will ingest 30 g of protein following exercise.
Energy BalanceOther
Participants will consume 40 kcal/kg FFM/day.
Post-Exercise CarbohydrateDietary supplement
Participants will ingest 30 g of carbohydrate following exercise.
Calcium and Vitamin DDietary supplement
Participants will be supplied Calcium and Vitamin D supplements throughout the study period matched to the CON condition.
| Study group | Role | What they receive |
|---|---|---|
| Energy Balance | Placebo comparator | Participants will be in energy balance and consume 1.2 g/kg BW protein. They will be provided 30 g of maltodextrin following exercise. Receives: Other: Energy Balance; Dietary Supplement: Post-Exercise Carbohydrate; Dietary Supplement: Calcium and Vitamin D |
| Caloric Restriction and CHO Supp | Active comparator | 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. Receives: Other: Caloric Restriction; Dietary Supplement: Post-Exercise Carbohydrate; Dietary Supplement: Calcium and Vitamin D |
| Caloric Restriction and PRO Supp | Experimental | 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. Receives: Other: Caloric Restriction; Dietary Supplement: Post-Exercise Protein; Dietary Supplement: Calcium and Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum [IGF-1] (ng/mL)
Measured via ELISA
Measured: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Change in Serum [GH] (pg/mL)
Measured via ELISA
Measured: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Change in Serum [IGFBP-3] (ng/mL)
Measured via ELISA
Measured: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Change in Serum [P1NP] (pg/mL)
Measured via ELISA
Measured: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Change in Serum [CTX] (ng/mL)
Measured via ELISA
Measured: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Change in Serum [Sclerostin] (pmol/L)
Measured via ELISA
Measured: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Secondary outcomes (3)
Change in Body Weight (kg)
Measured via Stadiometer
Measured: Baseline and Day 4
Change in Body Fat Percentage (%)
Measured via DXA and BIA
Measured: Baseline and Day 4
Change in Perceived Hunger (mm or %)
Measured on Visual Analog Scale within Survey
Measured: Baseline and Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start31 Aug 2018
- Primary completion1 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karsten Koehler, Principal investigator, University of Nebraska Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600311
- Sponsor's protocol ID
- 17933
- Acronym
- RIDE
- Status last verified
- Jun 2019
- First submitted
- 9 Jul 2018
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Resistance Exercise and Protein Consumption to Protect Bone Health During Weight Loss
- ClinicalTrials.gov ID
- NCT03600311
- Acronym / sponsor ID
- RIDE / 17933
- Conditions
- Weight Loss, Starvation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Energy Balance | Placebo comparator | Other: Energy Balance, Dietary Supplement: Post-Exercise Carbohydrate, Dietary Supplement: Calcium and Vitamin DParticipants will be in energy balance and consume 1.2 g/kg BW protein. They will be provided 30 g of maltodextrin following exercise. |
| Caloric Restriction and CHO Supp | Active comparator | Other: Caloric Restriction, Dietary Supplement: Post-Exercise Carbohydrate, Dietary Supplement: Calcium and Vitamin DParticipants 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. |
| Caloric Restriction and PRO Supp | Experimental | Other: Caloric Restriction, Dietary Supplement: Post-Exercise Protein, Dietary Supplement: Calcium and Vitamin DParticipants 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. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Lactose intolerant
- Pregnancy
- Taking interfering medications such as steroids, thyroid or growth hormones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric RestrictionParticipants will consume 15 kcal/kg FFM/day. | Other | Caloric Restriction and CHO Supp, Caloric Restriction and PRO Supp |
| Post-Exercise ProteinParticipants will ingest 30 g of protein following exercise. | Dietary supplement | Caloric Restriction and PRO Supp |
| Energy BalanceParticipants will consume 40 kcal/kg FFM/day. | Other | Energy Balance |
| Post-Exercise CarbohydrateParticipants will ingest 30 g of carbohydrate following exercise. | Dietary supplement | Caloric Restriction and CHO Supp, Energy Balance |
| Calcium and Vitamin DParticipants will be supplied Calcium and Vitamin D supplements throughout the study period matched to the CON condition. | Dietary supplement | Caloric Restriction and CHO Supp, Caloric Restriction and PRO Supp, Energy Balance |
Primary outcome
Change in Serum [IGF-1] (ng/mL)
Time frame: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Measured via ELISA
Change in Serum [GH] (pg/mL)
Time frame: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Measured via ELISA
Change in Serum [IGFBP-3] (ng/mL)
Time frame: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Measured via ELISA
Change in Serum [P1NP] (pg/mL)
Time frame: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Measured via ELISA
Change in Serum [CTX] (ng/mL)
Time frame: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Measured via ELISA
Change in Serum [Sclerostin] (pmol/L)
Time frame: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise
Measured via ELISA
3 secondary outcomes
Change in Body Weight (kg)
Time frame: Baseline and Day 4
Change in Body Fat Percentage (%)
Time frame: Baseline and Day 4
Change in Perceived Hunger (mm or %)
Time frame: Baseline and Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karsten Koehler principal investigator
University of Nebraska Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric Restriction, Post-Exercise Protein and Energy Balance in people with Weight Loss and Starvation, run by University of Nebraska Lincoln at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum [IGF-1] (ng/mL) (time frame: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019; AzTrials last refreshed its copy on 2 Nov 2026.