Metabolic SyndromeNCT00739479
CCRC: Effects of Partially Hydrolyzed Whey Peptides (PHWP) On Weight Loss In Individuals With The Metabolic Syndrome (METS)
A study testing Weight Loss in people with Metabolic Syndrome and Overweight, run by Sidika E. Karakas, MD at 1 site in United States.
Trial summary
The aim of this study is to compare the effects of two different protein supplements (partially hydrolyzed whey protein, PHWP vs. partially hydrolyzed gelatin, PHG) on weight loss in obse individuals with metabolic syndrome (METS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Overweight
- What is being tested?
- Weight Loss
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Aug 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnoses of Metabolic Syndrome (at least 3/5 of the following)
- Waist Circumference: men: >40 in women: >35 in
- Blood Pressure: >135/>85 mm Hg
- Triglycerides: >150 mg/dl
- HDL-cholesterol: men: <40 mg/dl women: <50 mg/dl
- Fasting Glucose: >100 mg/dl
Show all 10Show fewer
- Ages 18 to 65 Years
- BMI range of 27 to 42 kg/m^2
- Body weight <300 lbs
- Weight Stable for 3 Months
Who cannot join
- Subjects who habitually consume protein supplements or have eating disorders
- Recent delivery (within 12 months), lactation, pregnancy or intention to become pregnant
- Type 2 diabetes, kidney disease, liver disease, anemia, gout, cancer, untreated thyroid disease, gastrointestinal disease, other metabolic diseases or malabsorption syndromes
- Triglyceride >500 mg/dl, Cholesterol >260 mg/dl
- Use of insulin sensitizers, lipid lowering medication or ACE inhibitors
- Use of anti-obesity medications or supplements for at lease 6 months prior to start of study
- Known allergy or adverse reaction to protein and dairy products (including lactose)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare the effects of two different protein supplements (partially hydrolyzed whey protein, PHWP vs. partially hydrolyzed gelatin, PHG) on weight loss in obse individuals with metabolic syndrome (METS). These two supplements will contain equal amounts of protein but differ considerably in their amino acid contents. Whey protein is rich in essential amino acids whereas gelatin is rich in proline.
In obese individuals with METS, the hypotheses are:
- PHWP will augment fat-mass loss and increase lean-mass to fat-mass ration more than PHG.
- PHWP will improve insulin action more than PHG.
- PHWP will decrease cardiovascular disease risk more than PHG.
Read the detailed description
The Metabolic Syndrome (METS) is a clinical disorder characterized by the following problems: Obesity, especially located in the waist area, elevated blood fats (lipids), high blood pressure and insulin resistance. The METS affects one third of the adult population in the USA and increases the risks for both diabetes and hardening of the arteries, leading to heart attacks and strokes.
The best treatment for improving the symptoms of METS is weight loss. In previous studies, it has been demonstrated that whey protein (WP) supplementation increased weight loss and especially fat-mass loss in obese, insulin resistant women when compared to carbohydrates. We now propose to compare WP to another protein source in patients with the METS during weight loss. In addition, we will use a special preparation called partially hydrolyzed whey protein, which may have specific properties that increase fat mass loss.
- Conditions
- Metabolic Syndrome, Overweight
- Being tested
- Weight Loss
- Keywords
- Metabolic Syndrome, METS, Obesity, Partially Hydrolyzed Whey Protein, Partially Hydrolyzed Gelatin, PHWP, PHG, Weight Loss
- Medical subject headings
- Metabolic Syndrome, Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight LossDietary supplement
Participants will reduce their total dietary intake by ~800 kcal/day. ~100 kcal will be replaced by either the PHWP of PHG protein supplement, resulting in a total energy restriction of ~700 kcal/day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients will be randomized to receive PHWP. Since sex and baseline weight can influence the response, randomization will be stratified according to these variables. Receives: Dietary Supplement: Weight Loss |
| 2 | Placebo comparator | Patients will be randomized to receive PHG. Since sex and baseline weight can influence the response, randomization will be stratified according to these variables. Receives: Dietary Supplement: Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
The investigators hope to determine the effects of incorporating PHWP into the diet of a person diagnosed with METS.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidika E. Karakas, MD
- Sponsor type
- University, hospital or other
- Collaborators
- California Dairy Research Foundation
- Responsible party
- Sponsor-investigator, Sidika E. Karakas, MD, University of California, Davis
- Investigators
- Sidika E Kasim-Karakas, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739479
- Sponsor's protocol ID
- 200816190-1
- Status last verified
- Aug 2008
- First submitted
- 19 Aug 2008
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Piccolo BD, Comerford KB, Karakas SE, Knotts TA, Fiehn O, Adams SH. Whey protein supplementation does not alter plasma branched-chained amino acid profiles but results in unique metabolomics patterns in obese women enrolled in an 8-week weight loss trial. J Nutr. 2015 Apr;145(4):691-700. doi: 10.3945/jn.114.203943. Epub 2015 Feb 4.
PubMed 25833773Comerford KB, Buchan W, Karakas SE. The effects of weight loss on FABP4 and RBP4 in obese women with metabolic syndrome. Horm Metab Res. 2014 Mar;46(3):224-31. doi: 10.1055/s-0033-1353204. Epub 2013 Aug 26.
PubMed 23979787
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CCRC: Effects of Partially Hydrolyzed Whey Peptides (PHWP) On Weight Loss In Individuals With The Metabolic Syndrome (METS)
- ClinicalTrials.gov ID
- NCT00739479
- Acronym / sponsor ID
- 200816190-1
- Conditions
- Metabolic Syndrome, Overweight
- Keywords
- Metabolic Syndrome, METS, Obesity, Partially Hydrolyzed Whey Protein, Partially Hydrolyzed Gelatin, PHWP, PHG, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sidika E. Karakas, MDUniversity, hospital or other
- Collaborators
- California Dairy Research Foundation
- Study start
- Aug 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Aug 2008 (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 aim of this study is to compare the effects of two different protein supplements (partially hydrolyzed whey protein, PHWP vs. partially hydrolyzed gelatin, PHG) on weight loss in obse individuals with metabolic syndrome (METS). These two supplements will contain equal amounts of protein but differ considerably in their amino acid contents. Whey protein is rich in essential amino acids whereas gelatin is rich in proline.
In obese individuals with METS, the hypotheses are:
- PHWP will augment fat-mass loss and increase lean-mass to fat-mass ration more than PHG.
- PHWP will improve insulin action more than PHG.
- PHWP will decrease cardiovascular disease risk more than PHG.
Detailed description
The Metabolic Syndrome (METS) is a clinical disorder characterized by the following problems: Obesity, especially located in the waist area, elevated blood fats (lipids), high blood pressure and insulin resistance. The METS affects one third of the adult population in the USA and increases the risks for both diabetes and hardening of the arteries, leading to heart attacks and strokes.
The best treatment for improving the symptoms of METS is weight loss. In previous studies, it has been demonstrated that whey protein (WP) supplementation increased weight loss and especially fat-mass loss in obese, insulin resistant women when compared to carbohydrates. We now propose to compare WP to another protein source in patients with the METS during weight loss. In addition, we will use a special preparation called partially hydrolyzed whey protein, which may have specific properties that increase fat mass loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Weight LossPatients will be randomized to receive PHWP. Since sex and baseline weight can influence the response, randomization will be stratified according to these variables. |
| 2 | Placebo comparator | Dietary Supplement: Weight LossPatients will be randomized to receive PHG. Since sex and baseline weight can influence the response, randomization will be stratified according to these variables. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Clinical Diagnoses of Metabolic Syndrome (at least 3/5 of the following)
- Ages 18 to 65 Years
- BMI range of 27 to 42 kg/m^2
- Body weight <300 lbs
- Weight Stable for 3 Months
Key exclusion criteria (7 listed)
- Subjects who habitually consume protein supplements or have eating disorders
- Recent delivery (within 12 months), lactation, pregnancy or intention to become pregnant
- Type 2 diabetes, kidney disease, liver disease, anemia, gout, cancer, untreated thyroid disease, gastrointestinal disease, other metabolic diseases or malabsorption syndromes
- Triglyceride >500 mg/dl, Cholesterol >260 mg/dl
- Use of insulin sensitizers, lipid lowering medication or ACE inhibitors
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 |
|---|---|---|
| Weight LossParticipants will reduce their total dietary intake by ~800 kcal/day. ~100 kcal will be replaced by either the PHWP of PHG protein supplement, resulting in a total energy restriction of ~700 kcal/day. | Dietary supplement | 1, 2 |
Primary outcome
The investigators hope to determine the effects of incorporating PHWP into the diet of a person diagnosed with METS.
Time frame: 2 Years
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 29 Oct 2012.
- Derived from this study: PubMed 25833773Piccolo BD, Comerford KB, Karakas SE, Knotts TA, Fiehn O, Adams SH. Whey protein supplementation does not alter plasma branched-chained amino acid profiles but results in unique metabolomics patterns in obese women enrolled in an 8-week weight loss trial. J Nutr. 2015 Apr;145(4):691-700. doi: 10.3945/jn.114.203943. Epub 2015 Feb 4.
- Derived from this study: PubMed 23979787Comerford KB, Buchan W, Karakas SE. The effects of weight loss on FABP4 and RBP4 in obese women with metabolic syndrome. Horm Metab Res. 2014 Mar;46(3):224-31. doi: 10.1055/s-0033-1353204. Epub 2013 Aug 26.
- UC Davis Website - Featured Clinical TrialsLink provided by the sponsor.
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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.
Sidika E Kasim-Karakas, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss in people with Metabolic Syndrome and Overweight, run by Sidika E. Karakas, MD 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 10 inclusion and 7 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 29 Oct 2012. 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?
The investigators hope to determine the effects of incorporating PHWP into the diet of a person diagnosed with METS. (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00739479, which also lists 2 linked publications.
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 29 Oct 2012.