Healthy VolunteersNCT03034668
Botanical Supplement Muscle Function and Lean Body Mass
A study testing CS16-003 Full dose and CS16-003 Half dose in people with Healthy Volunteers, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To evaluate the acute and chronic effects of a botanical supplement on strength, muscle function, and lean body mass Participants: The acute phase will include 30 participants, and the chronic phase will include 84 participants. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CS16-003 Full dose and CS16-003 Half dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Aug 2018
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreationally Active (1- 4 hours of exercise/ sports participation per week and no more than 1 hour of resistance training exercise per week) for the previous 12 weeks.
- BMI < 30 kg/m²
- Have not smoked in the past year.
- Participant has provided written and dated informed consent to participate in the study
- Participant is willing and able to comply with the protocol
- Participant is apparently healthy and free from disease, as determined by a health history questionnaire
- Participant agrees to abstain from caffeine, tobacco, alcohol, and exercise within 24 hours of testing visits
Who cannot join
- Participant has not used any dietary supplements within 12 weeks prior to enrollment and will not begin supplementation during the study. Potential supplements include but are not limited to Beta-alanine, Creatine, HMB, Carnosine, Taurine, androstenedione, DHEA, Whey protein, or a pre-workout supplement.
- Participant has gained or lost 10 lbs in the previous 2 months.
- Participant is currently enrolled in a separate clinical trial.
- Participant has participated in a clinical trial within the previous 2 months that includes modifications to their physical and/or diet.
- Participant has a known allergy or sensitivity to the placebo (maltodextrin) or active ingredients (Rhodiola \& Rhaptonicum)
- Participant consumes more than 8 cups (1 cup = 6 oz) of coffee per day on a regular basis
Show all 9Show fewer
- Participant consumes more than 3 alcoholic drinks per day.
- Participant uses recreational drugs daily.
- Previous physical symptoms causing a physician to recommend you to refrain from exercise.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Department of Exercise and Sport Science
Chapel Hill, North Carolina, 27599
About this study
Official title: The Acute and Chronic Influence of a Botanical Supplement on Muscle Function and Lean Body Mass
Purpose: To evaluate the acute and chronic effects of a botanical supplement on strength, muscle function, and lean body mass
Participants: The acute phase will include 30 participants, and the chronic phase will include 84 participants. All participants must be healthy recreationally active males between the ages of 18 and 35 years.
Read more
Procedures (methods):
Acute phase: Participants will complete three testing visits as part of as part of a cross-over design, during which strength and muscle function will be assessed prior to and following consumption of a supplement. The experimental supplement is a blend of the botanical extracts; treatment arms will include a full dose (FULL; 350 mg capsule), half dose (HALF; 175 mg plus maltodextrin), or placebo (PLA; maltodextrin).
Chronic phase: Body composition, muscle cross-sectional area, a complete blood count and metabolic panel, subjective surveys, and strength will be measured prior to and following an 8-week supervised resistance training program, in conjunction with daily supplementation of FULL, HALF, or PLA.
- Conditions
- Healthy Volunteers
- Being tested
- CS16-003 Full dose, CS16-003 Half dose, Placebo
- Keywords
- Botanical Supplement, Performance-Enhancing Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS16-003 Full doseDietary supplement
350 mg 'Rhodiola rosea L. \& Rhaptonticum carthamoides extracts
CS16-003 Half doseDietary supplement
175 mg 'Rhodiola rosea L. \& Rhaptonticum carthamoides extracts + maltodextrin 175 mg
PlaceboDietary supplement
Maltodextrin: 350 mg
| Study group | Role | What they receive |
|---|---|---|
| CS16-003 Full dose | Experimental | 350 mg capsule QD Rhodiola rosea L. \& Rhaptonticum carthamoides extracts Receives: Dietary Supplement: CS16-003 Full dose |
| CS16-003 Half dose | Experimental | 175 mg capsule QD 50% Rhodiola rosea L. \& Rhaptonticum carthamoides extracts + 50% Maltodextrin Receives: Dietary Supplement: CS16-003 Half dose |
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Isokinetic Leg Extension strength measured by dynamometry
Measured: Acute/Immediate
Maximal Upper and Lower Body Strength measured by 1 repetition maximum
Measured: 8 weeks
Secondary outcomes (8)
Bench Press Repetitions to Fatigue
Measured: 8 weeks
Leg Press Repetitions to Fatigue
Measured: 8 weeks
Body Composition-Lean Mass
Measured: 8 weeks
Body Composition-Fat Mass
Measured: 8 weeks
Muscle cross sectional area
Measured: 8 weeks
Change in Quality of Life Score from baseline to 8 weeks
Quality of life from a visual analog scale (VAS) 0-100, with 0 = worst quality of life and 100=best quality of life.
Measured: baseline, 8 weeks
Change in Felt Arousal score from baseline to 8 weeks
Felt arousal scale. Scores range 1-6 with 1 being low arousal and 6 being high. One score selected.
Measured: baseline, 8 weeks
Change in Mood score from baseline to 8 weeks
Mood determined from a VAS. 0-100, with 0 = not depressed at all and 100 = most depressed.
Measured: baseline; 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Givaudan France Naturals
- Responsible party
- Sponsor
- Investigators
- Eric Ryan, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034668
- Sponsor's protocol ID
- 16-1991
- Status last verified
- Sep 2018
- First submitted
- 17 Jan 2017
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute and Chronic Influence of a Botanical Supplement on Muscle Function and Lean Body Mass
- ClinicalTrials.gov ID
- NCT03034668
- Acronym / sponsor ID
- 16-1991
- Conditions
- Healthy Volunteers
- Keywords
- Botanical Supplement, Performance-Enhancing Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Givaudan France Naturals
- Study start
- Nov 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 27 Jan 2017 (estimated)
- 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.
Purpose: To evaluate the acute and chronic effects of a botanical supplement on strength, muscle function, and lean body mass
Participants: The acute phase will include 30 participants, and the chronic phase will include 84 participants. All participants must be healthy recreationally active males between the ages of 18 and 35 years.
Procedures (methods):
Acute phase: Participants will complete three testing visits as part of as part of a cross-over design, during which strength and muscle function will be assessed prior to and following consumption of a supplement. The experimental supplement is a blend of the botanical extracts; treatment arms will include a full dose (FULL; 350 mg capsule), half dose (HALF; 175 mg plus maltodextrin), or placebo (PLA; maltodextrin).
Chronic phase: Body composition, muscle cross-sectional area, a complete blood count and metabolic panel, subjective surveys, and strength will be measured prior to and following an 8-week supervised resistance training program, in conjunction with daily supplementation of FULL, HALF, or PLA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CS16-003 Full dose | Experimental | Dietary Supplement: CS16-003 Full dose350 mg capsule QD Rhodiola rosea L. \& Rhaptonticum carthamoides extracts |
| CS16-003 Half dose | Experimental | Dietary Supplement: CS16-003 Half dose175 mg capsule QD 50% Rhodiola rosea L. \& Rhaptonticum carthamoides extracts + 50% Maltodextrin |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Recreationally Active (1- 4 hours of exercise/ sports participation per week and no more than 1 hour of resistance training exercise per week) for the previous 12 weeks.
- BMI < 30 kg/m²
- Have not smoked in the past year.
- Participant has provided written and dated informed consent to participate in the study
- Participant is willing and able to comply with the protocol
Key exclusion criteria (9 listed)
- Participant has not used any dietary supplements within 12 weeks prior to enrollment and will not begin supplementation during the study. Potential supplements include but are not limited to Beta-alanine, Creatine, HMB, Carnosine, Taurine, androstenedione, DHEA, Whey protein, or a pre-workout supplement.
- Participant has gained or lost 10 lbs in the previous 2 months.
- Participant is currently enrolled in a separate clinical trial.
- Participant has participated in a clinical trial within the previous 2 months that includes modifications to their physical and/or diet.
- Participant has a known allergy or sensitivity to the placebo (maltodextrin) or active ingredients (Rhodiola \& Rhaptonicum)
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 |
|---|---|---|
| CS16-003 Full dose350 mg 'Rhodiola rosea L. \& Rhaptonticum carthamoides extracts | Dietary supplement | CS16-003 Full dose |
| CS16-003 Half dose175 mg 'Rhodiola rosea L. \& Rhaptonticum carthamoides extracts + maltodextrin 175 mg | Dietary supplement | CS16-003 Half dose |
| PlaceboMaltodextrin: 350 mg | Dietary supplement | Placebo |
Primary outcome
Maximal Isokinetic Leg Extension strength measured by dynamometry
Time frame: Acute/Immediate
Maximal Upper and Lower Body Strength measured by 1 repetition maximum
Time frame: 8 weeks
8 secondary outcomes
Bench Press Repetitions to Fatigue
Time frame: 8 weeks
Leg Press Repetitions to Fatigue
Time frame: 8 weeks
Body Composition-Lean Mass
Time frame: 8 weeks
Body Composition-Fat Mass
Time frame: 8 weeks
Muscle cross sectional area
Time frame: 8 weeks
Change in Quality of Life Score from baseline to 8 weeks
Time frame: baseline, 8 weeks
Change in Felt Arousal score from baseline to 8 weeks
Time frame: baseline, 8 weeks
Change in Mood score from baseline to 8 weeks
Time frame: baseline; 8 weeks
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 18 Sep 2018.
- 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.
Eric Ryan, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CS16-003 Full dose and CS16-003 Half dose in people with Healthy Volunteers, run by University of North Carolina, Chapel Hill 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 7 inclusion and 9 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 18 Sep 2018. 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?
Maximal Isokinetic Leg Extension strength measured by dynamometry (time frame: Acute/Immediate). The study lists 2 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 18 Sep 2018.