ObesityNCT01915030
Protect - The Impact of a High Protein Diet on Preservation of Muscle Mass
A study testing High protein diet and standard protein diet in people with Obesity, run by Wageningen University at 1 site in Netherlands.
Trial summary
The present study is designed to investigate whether a high protein diet will preserve muscle mass during caloric restriction in older adults. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- High protein diet and standard protein diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2012to Dec 2012
- 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 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight and obese subjects (BMI 27-40 kg/m2)
- Waist circumference male:≥ 102 cm, female: ≥ 88 cm
- Willingness and ability to comply with the protocol
Who cannot join
- Renal insufficiency
- Co-morbidities
- Type 1 \& 2 diabetics (Fasting glucose level ≥ 7 mmol/L)
- Cancer
- COPD
- Participation in weight loss program 3 months before the intervention
Show all 14Show fewer
- Participation of any heavy resistance-type exercise training (>1 wk) the last 2 y.
- Intentional or unintentional weight loss (> 3 kg in the last 3 months)
- Severe loss appetite
- Diagnosed allergy to milk products
- Gastric bypass
- Supplements or medication use for weight loss
- Participation in any other intervention trial
- Women can only participate if they are postmenopausal (last period ≥ a year ago)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protect The Impact of a High Protein Diet on the Preservation of Muscle Mass During Caloric Restriction in Middle Age and Elderly People
The present study is designed to investigate whether a high protein diet will preserve muscle mass during caloric restriction in older adults.
- Conditions
- Obesity
- Being tested
- High protein diet, standard protein diet
- Keywords
- Muscle, Physical performance, Protein, Diet, Caloric restriction
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein dietOther
controlled feeding trail. Both arms are caloric restricted
standard protein dietOther
| Study group | Role | What they receive |
|---|---|---|
| High protein diet | Experimental | High protein diet during caloric restriction Receives: Other: High protein diet |
| Standard protein diet | Placebo comparator | Standard protein diet during caloric restriction Receives: Other: standard protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body composition
DEXA scan
Measured: baseline and 12 weeks
Secondary outcomes (4)
Physical performance
- Short Physical Performance Battery (SPPB), maximum score is 12.
- Leg strength by 1 Repetition Maximum, both leg extension and leg press
- Handgrip strength
- Time to walk 400m
Measured: baseline and 12 weeks
Blood related parameters
Glucose, insulin, HbA1c, lipid profile
Measured: baseline and 12 weeks
Muscle related parameters
muscle biopsies (muscle fiber type)
Measured: baseline and 12 weeks
Physical activity
Questionnaire LAPAQ - Activities of Daily Living
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, Top Institute Food and Nutrition
- Responsible party
- Sponsor
- Investigators
- Lisette de Groot, professor, Principal investigator, Prof. Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915030
- Sponsor's protocol ID
- WM002-wp3
- Status last verified
- Jul 2013
- First submitted
- 31 Jul 2012
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protect The Impact of a High Protein Diet on the Preservation of Muscle Mass During Caloric Restriction in Middle Age and Elderly People
- ClinicalTrials.gov ID
- NCT01915030
- Acronym / sponsor ID
- WM002-wp3
- Conditions
- Obesity
- Keywords
- Muscle, Physical performance, Protein, Diet, Caloric restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Maastricht University, Top Institute Food and Nutrition
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Aug 2013 (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.
The present study is designed to investigate whether a high protein diet will preserve muscle mass during caloric restriction in older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High protein diet | Experimental | Other: High protein dietHigh protein diet during caloric restriction |
| Standard protein diet | Placebo comparator | Other: standard protein dietStandard protein diet during caloric restriction |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overweight and obese subjects (BMI 27-40 kg/m2)
- Waist circumference male:≥ 102 cm, female: ≥ 88 cm
- Willingness and ability to comply with the protocol
Key exclusion criteria (14 listed)
- Renal insufficiency
- Co-morbidities
- Type 1 \& 2 diabetics (Fasting glucose level ≥ 7 mmol/L)
- Cancer
- COPD
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 |
|---|---|---|
| High protein dietcontrolled feeding trail. Both arms are caloric restricted | Other | High protein diet |
| standard protein diet | Other | Standard protein diet |
Primary outcome
Change in Body composition
Time frame: baseline and 12 weeks
DEXA scan
4 secondary outcomes
Physical performance
Time frame: baseline and 12 weeks
Blood related parameters
Time frame: baseline and 12 weeks
Muscle related parameters
Time frame: baseline and 12 weeks
Physical activity
Time frame: baseline and 12 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 2 Aug 2013.
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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.
Lisette de Groot, professor principal investigator
Prof. Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein diet and standard protein diet in people with Obesity, run by Wageningen University at 1 site in Netherlands.
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 3 inclusion and 14 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 2 Aug 2013. 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 Netherlands. 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 Body composition (time frame: baseline and 12 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 2 Aug 2013.