OverweightNCT02315014
Daily Protein Intake Distribution and MPS (ARCIII)
A study testing whey protein in people with Overweight, run by Société des Produits Nestlé (SPN).
Trial summary
To determine whether a balanced total daily dietary protein distribution supplemented with whey protein during a weight-loss intervention will result in increased muscle protein synthesis Read more about this study
- Who is it for?
- Ages 60 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jun 2014
- 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 60 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight/obese (BMI 27-40 kg/m2)
- Non-smokers
- Non-diabetic
- No history of hyperlipidemia
- Not taking medications thought to interfere with study
- Considered generally healthy
Who cannot join
- Efforts to lose weight in previous 16 weeks
- Hyperlipidemia
- Blood pressure ≥ 140/90 mmHg
- Smoking
- Heart and other organ disease
- Type 2 diabetes
Show all 9Show fewer
- Gastrointestinal disease
- Orthopedic injury interfering with exercise
- Use of certain medications (HRT, antihypertensives, diuretics, antiarythmia medications, antiresorptive agents, anabolic agents, hypoglycemic agents, and statins known to affect muscle i.e. Simvastatin and Zocor)
About this study
Official title: Effect of Balanced Daily Protein Distribution Supplemented With Whey Protein on Muscle Protein Synthesis in Overweight Older Men During Calorie Restriction and Exercise (ARC III)
To determine whether a balanced total daily dietary protein distribution supplemented with whey protein during a weight-loss intervention will result in increased muscle protein synthesis
- Conditions
- Overweight
- Being tested
- whey protein, placebo
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey proteinOther
whey protein.
placeboOther
placebo.
| Study group | Role | What they receive |
|---|---|---|
| whey protein | Experimental | whey protein micelles Receives: Other: whey protein |
| placebo | Placebo comparator | calorie-free placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle protein synthesis
protein synthesis is evaluated in muscle biopsy tissue
Measured: up to 4 weeks
Secondary outcomes (1)
body composition is evaluated using DEXA
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Phillips, Ph.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315014
- Sponsor's protocol ID
- 12.12.NRC
- Status last verified
- Nov 2014
- First submitted
- 13 Nov 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Balanced Daily Protein Distribution Supplemented With Whey Protein on Muscle Protein Synthesis in Overweight Older Men During Calorie Restriction and Exercise (ARC III)
- ClinicalTrials.gov ID
- NCT02315014
- Acronym / sponsor ID
- 12.12.NRC
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Dec 2014 (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.
To determine whether a balanced total daily dietary protein distribution supplemented with whey protein during a weight-loss intervention will result in increased muscle protein synthesis
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whey protein | Experimental | Other: whey proteinwhey protein micelles |
| placebo | Placebo comparator | Other: placebocalorie-free placebo |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Overweight/obese (BMI 27-40 kg/m2)
- Non-smokers
- Non-diabetic
- No history of hyperlipidemia
- Not taking medications thought to interfere with study
Key exclusion criteria (9 listed)
- Efforts to lose weight in previous 16 weeks
- Hyperlipidemia
- Blood pressure ≥ 140/90 mmHg
- Smoking
- Heart and other organ disease
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 |
|---|---|---|
| whey proteinwhey protein. | Other | whey protein |
| placeboplacebo. | Other | placebo |
Primary outcome
muscle protein synthesis
Time frame: up to 4 weeks
protein synthesis is evaluated in muscle biopsy tissue
1 secondary outcome
body composition is evaluated using DEXA
Time frame: up to 4 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 11 Dec 2014.
Related trials for Overweight
RecruitingPhase 2
Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
Healthy Volunteers, Overweight
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruitingPhase 1
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
Healthy Volunteers, Overweight or Obesity
Active, not recruitingPhase 2
A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity
Overweight, Obesity
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity
Obesity, Overweight and/or Obesity
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.
Stuart Phillips, Ph.D. principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing whey protein in people with Overweight, run by Société des Produits Nestlé (SPN).
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 6 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 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
muscle protein synthesis (time frame: up to 4 weeks). 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 11 Dec 2014.