Dietary ModificationS43NCT02506218
Optimizing Meal and Snack Timing to Promote Health
A study testing 10 + 20 g protein consumption, 30 g protein breakfast and 10 g protein breakfast in people with Dietary Modification, run by Purdue University at 1 site in United States.
Trial summary
This study will be conducted using standardized techniques to collect blood samples via an acute, randomized, cross-over design. Subjects will be provided all of their meals the day prior to testing and participate in 3 testing days with a minimum of 1 week break between testing days and a maximum time commitment of 7… Read more about this study
- Who is it for?
- Ages 25 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- 10 + 20 g protein consumption, 30 g protein breakfast and 10 g protein breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Mar 2016
- 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 25 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 25-39 years old
- BMI between 22-37 kg/m2
- Weight stable (± 4.5 kg) for the previous 3 months
- Not currently (or within the past 6 months) following a vigorous exercise regimen or weight loss program
- No acute illness
- Not smoking
Show all 11Show fewer
- Not diabetic
- Not pregnant or planning pregnancy in the next 3 months
- Lactose tolerant
- Willing to limit purposeful activity for 48 hours prior to each testing day
- Willing to consume study foods and beverages.
Who cannot join
- <25 or >39 years old, BMI <22 or >37 kg/m2
- Currently (or within the past 6 months) following a vigorous exercise regimen greater than -3 - 45 minute exercise sessions per week
- Currently following a weight loss program where subject has lost greater than 4.5 kg
- Acute illness
- Smoking
- Diabetic
Show all 10Show fewer
- Pregnant or planning pregnancy in the next 3 months
- Lactose intolerant
- Unwilling to consume study foods and beverages
- Peri and post-menopausal women.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted using standardized techniques to collect blood samples via an acute, randomized, cross-over design. Subjects will be provided all of their meals the day prior to testing and participate in 3 testing days with a minimum of 1 week break between testing days and a maximum time commitment of 7 weeks. A trained phlebotomist will place a catheter and collect blood samples from an antecubital vein using sterile techniques.
- Conditions
- Dietary Modification
- Being tested
- 10 + 20 g protein consumption, 30 g protein breakfast, 10 g protein breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 + 20 g protein consumptionDietary supplement
whey isolate
30 g protein breakfastOther
30 g mixed meal breakfast
10 g protein breakfastOther
10 g mixed meal breakfast
| Study group | Role | What they receive |
|---|---|---|
| 10 + 20 g protein consumption | Experimental | 10 g breakfast followed by the consumption of a 20g whey protein shake Receives: Dietary Supplement: 10 + 20 g protein consumption |
| 30 g protein breakfast | Active comparator | Not described Receives: Other: 30 g protein breakfast |
| 10 g protein breakfast | Active comparator | Not described Receives: Other: 10 g protein breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amino acid concentration
Peak plasma concentration of amino acids
Measured: 7 weeks
Secondary outcomes (1)
Blood glucose concentration
Area under the curve of blood glucose
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506218
- Sponsor's protocol ID
- 1501015661
- Acronym
- S43
- Status last verified
- Jan 2018
- First submitted
- 24 Jun 2015
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Meal and Snack Timing to Promote Health
- ClinicalTrials.gov ID
- NCT02506218
- Acronym / sponsor ID
- S43 / 1501015661
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Jul 2015 (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.
This study will be conducted using standardized techniques to collect blood samples via an acute, randomized, cross-over design. Subjects will be provided all of their meals the day prior to testing and participate in 3 testing days with a minimum of 1 week break between testing days and a maximum time commitment of 7 weeks. A trained phlebotomist will place a catheter and collect blood samples from an antecubital vein using sterile techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 + 20 g protein consumption | Experimental | Dietary Supplement: 10 + 20 g protein consumption10 g breakfast followed by the consumption of a 20g whey protein shake |
| 30 g protein breakfast | Active comparator | Other: 30 g protein breakfast |
| 10 g protein breakfast | Active comparator | Other: 10 g protein breakfast |
Who may qualify
- Ages
- 25 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 25-39 years old
- BMI between 22-37 kg/m2
- Weight stable (± 4.5 kg) for the previous 3 months
- Not currently (or within the past 6 months) following a vigorous exercise regimen or weight loss program
- No acute illness
Key exclusion criteria (10 listed)
- <25 or >39 years old, BMI <22 or >37 kg/m2
- Currently (or within the past 6 months) following a vigorous exercise regimen greater than -3 - 45 minute exercise sessions per week
- Currently following a weight loss program where subject has lost greater than 4.5 kg
- Acute illness
- Smoking
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 |
|---|---|---|
| 10 + 20 g protein consumptionwhey isolate | Dietary supplement | 10 + 20 g protein consumption |
| 30 g protein breakfast30 g mixed meal breakfast | Other | 30 g protein breakfast |
| 10 g protein breakfast10 g mixed meal breakfast | Other | 10 g protein breakfast |
Primary outcome
Plasma amino acid concentration
Time frame: 7 weeks
Peak plasma concentration of amino acids
1 secondary outcome
Blood glucose concentration
Time frame: 7 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 12 Jan 2018.
Related trials for Dietary Modification
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 + 20 g protein consumption, 30 g protein breakfast and 10 g protein breakfast in people with Dietary Modification, run by Purdue University 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 11 inclusion and 10 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 Jan 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. 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?
Plasma amino acid concentration (time frame: 7 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 12 Jan 2018.