Blood Sugar (Glucose) ControlPhase 1NCT01814358
Whey Protein Effects on Gycemic Control and Vascular Function
A Phase 1 study testing Whey protein powder in people with Blood Sugar (Glucose) Control and Blood Vessel (Vascular) Dysfunction, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Risk for heart and blood vessel diseases is increased when blood sugar rises. Blood vessel dysfunction is common to such diseases. Elevated blood sugar after eating promotes blood vessel dysfunction. Dietary factors other than carbohydrates influence rises and falls in blood sugar. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Sugar (Glucose) Control, Blood Vessel (Vascular) Dysfunction
- What is being tested?
- Whey protein powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2015
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years
- BMI between 18.5 and 25 or ≥ 30
- Willingness to provide written informed consent
Who cannot join
- Pregnant or breastfeeding currently or in prior 6 months
- Menopause in women
- Regular consumption of > 1 serving per day of milk/yogurt
- Known heart arrhythmia
- Use of tobacco products
- Any disease/pathological condition known to influence outcomes
- Use of medications/dietary supplements known to influence outcomes
- Recent or planned changes in diet/exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pre-meal Whey Protein Ingestion on Daily Glycemic Control and Oxidative Stress Mediated Postprandial Inflammation and Vascular Dysfunction Evoked by Consumption of a High-glycemic Meal
Risk for heart and blood vessel diseases is increased when blood sugar rises. Blood vessel dysfunction is common to such diseases. Elevated blood sugar after eating promotes blood vessel dysfunction. Dietary factors other than carbohydrates influence rises and falls in blood sugar. Dietary protein is associated with improved blood sugar control. Whey protein effectively blunts the rise in blood sugar after consuming a carbohydrate rich drink/meal in normal weight and obese adults. This study will investigate the efficacy of drinking a whey protein beverage prior to eating for improved daily blood sugar control in normal weight and obese adults in the "real world." Also, the study will test this dietary approach to reduce blood vessel dysfunction associated with eating a meal that causes blood sugar to rise. 24 normal weight and 24 obese men and premenopausal women (18-50y) will participate. Subjects will wear a sensor to monitor daily blood sugar changes in response to their typically consumed diets for 2 days. Subjects will report to the UCLA CTRC the morning after the monitoring period for measurement of blood vessel function after eating a breakfast cereal meal. Blood samples will be obtained before and after the meal to measure relevant health markers. Subjects will repeat the 2-day diet and breakfast cereal meal challenge after a week or more, and will consume either a chocolate flavored 1) whey protein or 2) gelatin protein (control) shake prior to each meal. Neither subjects nor researchers will know which protein ("double blind"). Subjects will receive the alternate protein intervention after another week or more ("crossover"). We think drinking the protein shake prior to meals will reduce daily blood sugar rises and falls after eating and blunt the blood vessel dysfunction that results from eating the breakfast cereal.
- Being tested
- Whey protein powder, Control protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein powderDietary supplement
Subjects on this arm will consume 20g whey protein powder mixed with water 15 minutes prior to breakfast, lunch, and dinner for two days
Control proteinDietary supplement
Subjects on this arm will consume 20g gelatin protein powder mixed with water 15 minutes prior to breakfast, lunch, and dinner for two days
| Study group | Role | What they receive |
|---|---|---|
| Whey protein | Experimental | Subjects on this arm will receive whey protein Receives: Dietary Supplement: Whey protein powder |
| Gelatin protein | Active comparator | Subjects on this arm will consume gelatin protein Receives: Dietary Supplement: Control protein |
| Control arm | No intervention | Subjects on this arm will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average 24 hour glucose
The 24-hour glucose level (average of 48-hour monitoring period) for whey protein arm compared to other protein arm
Measured: 48 hours
Secondary outcomes (4)
Glycemic variability
Measured: 48 hours
Post-meal percent change Brachial Artery Flow Mediated Dilation (FMD)
Measured: 120 minutes
Post-meal monocyte inflammatory signaling
Measured: 60 minutes
Post-meal percent change femoral artery blood flow (FBF)
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Sugar (Glucose) ControlStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Thomas, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814358
- Sponsor's protocol ID
- Thomas whey 01
- Status last verified
- Sep 2023
- First submitted
- 15 Mar 2013
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-meal Whey Protein Ingestion on Daily Glycemic Control and Oxidative Stress Mediated Postprandial Inflammation and Vascular Dysfunction Evoked by Consumption of a High-glycemic Meal
- ClinicalTrials.gov ID
- NCT01814358
- Acronym / sponsor ID
- Thomas whey 01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 19 Mar 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.
Risk for heart and blood vessel diseases is increased when blood sugar rises. Blood vessel dysfunction is common to such diseases. Elevated blood sugar after eating promotes blood vessel dysfunction. Dietary factors other than carbohydrates influence rises and falls in blood sugar. Dietary protein is associated with improved blood sugar control. Whey protein effectively blunts the rise in blood sugar after consuming a carbohydrate rich drink/meal in normal weight and obese adults. This study will investigate the efficacy of drinking a whey protein beverage prior to eating for improved daily blood sugar control in normal weight and obese adults in the "real world." Also, the study will test this dietary approach to reduce blood vessel dysfunction associated with eating a meal that causes blood sugar to rise. 24 normal weight and 24 obese men and premenopausal women (18-50y) will participate. Subjects will wear a sensor to monitor daily blood sugar changes in response to their typically consumed diets for 2 days. Subjects will report to the UCLA CTRC the morning after the monitoring period for measurement of blood vessel function after eating a breakfast cereal meal. Blood samples will be obtained before and after the meal to measure relevant health markers. Subjects will repeat the 2-day diet and breakfast cereal meal challenge after a week or more, and will consume either a chocolate flavored 1) whey protein or 2) gelatin protein (control) shake prior to each meal. Neither subjects nor researchers will know which protein ("double blind"). Subjects will receive the alternate protein intervention after another week or more ("crossover"). We think drinking the protein shake prior to meals will reduce daily blood sugar rises and falls after eating and blunt the blood vessel dysfunction that results from eating the breakfast cereal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whey protein | Experimental | Dietary Supplement: Whey protein powderSubjects on this arm will receive whey protein |
| Gelatin protein | Active comparator | Dietary Supplement: Control proteinSubjects on this arm will consume gelatin protein |
| Control arm | No intervention | –Subjects on this arm will receive no intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-50 years
- BMI between 18.5 and 25 or ≥ 30
- Willingness to provide written informed consent
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding currently or in prior 6 months
- Menopause in women
- Regular consumption of > 1 serving per day of milk/yogurt
- Known heart arrhythmia
- Use of tobacco products
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 protein powderSubjects on this arm will consume 20g whey protein powder mixed with water 15 minutes prior to breakfast, lunch, and dinner for two days | Dietary supplement | Whey protein |
| Control proteinSubjects on this arm will consume 20g gelatin protein powder mixed with water 15 minutes prior to breakfast, lunch, and dinner for two days | Dietary supplement | Gelatin protein |
Primary outcome
Average 24 hour glucose
Time frame: 48 hours
The 24-hour glucose level (average of 48-hour monitoring period) for whey protein arm compared to other protein arm
4 secondary outcomes
Glycemic variability
Time frame: 48 hours
Post-meal percent change Brachial Artery Flow Mediated Dilation (FMD)
Time frame: 120 minutes
Post-meal monocyte inflammatory signaling
Time frame: 60 minutes
Post-meal percent change femoral artery blood flow (FBF)
Time frame: 120 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
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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.
Anthony Thomas, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Whey protein powder in people with Blood Sugar (Glucose) Control and Blood Vessel (Vascular) Dysfunction, run by University of California, Los Angeles 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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 2 Oct 2023. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Average 24 hour glucose (time frame: 48 hours). 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 Oct 2023.