Metabolic SyndromeNCT03591588
Effects of Diet Interventions on Monocytes in Metabolic Syndrome
A study testing diet in people with Metabolic Syndrome and Hypertriglyceridemia, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4 days (days 1-4) and a breakfast on day 5. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Metabolic Syndrome, Hypertriglyceridemia
- What is being tested?
- diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 31 Mar 2020
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese women and men with metabolic syndrome (MS)
- Fasting triglyceride (TG) equal to or greater than 150 mg/dl
Who cannot join
- <21 years of age
- Perimenopausal, pregnant or breastfeeding women
- Current smokers
- Obvious inflammation or other acute illnesses
- Obesity due to endocrinologic disorders including polycystic ovary syndrome
- Partial lipodystrophy
Show all 12Show fewer
- Diabetes requiring insulin or >1 oral medication
- Fasting TG ≥650 mg/dl
- A history of pancreatitis
- Myocardial infarction within the past 3 years
- Any hospitalization within the past 2 months
- Takes steroids.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Prevention of cardiometabolic disease
Houston, Texas, 77030
About this study
Official title: Effects of Diet Interventions on Monocyte Phenotypes in Individuals With Metabolic Syndrome
Subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4 days (days 1-4) and a breakfast on day 5. Blood samples are collected on day 1 and day 5 to examine lipid levels and circulating monocyte phenotypes.
Read the detailed description
Subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4 days (days 1-4) and a breakfast on day 5. Blood samples are collected on day 1 at fasting state and on day 5 at fasting state and 4 and 6 hours after the breakfast to examine lipid levels and circulating monocyte phenotypes.
- Conditions
- Metabolic Syndrome, Hypertriglyceridemia
- Being tested
- diet
- Medical subject headings
- Metabolic Syndrome, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietOther
The study includes 2 types of diets, i.e., high-saturated fat diet and low-fat high-protein diet, which are provided to each participant in a randomized crossover design.
| Study group | Role | What they receive |
|---|---|---|
| high-saturated fat diet | Active comparator | Diet high in saturated fat (~50% calorie from fat, ~25% from saturated fat) Receives: Other: diet |
| low-fat diet | Active comparator | Diet with low fat (~25% calorie from fat) Receives: Other: diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of diet interventions on monocyte phenotypes
Monocyte phenotypes
Measured: 2016 to 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Apr 2016
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study includes 2 types of diets, i.e., high-saturated fat diet and low-fat high-protein diet, in the same individuals with randomized crossover design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huaizhu Wu, Baylor College of Medicine
- Investigators
- HUAIZHU WU, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591588
- Sponsor's protocol ID
- H21418
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lian Z, Perrard XD, Antony AK, Peng X, Xu L, Ni J, Zhang B, O'Brien V, Saeed A, Jia X, Hussain A, Yu B, Simon SI, Sacks FM, Hoogeveen RC, Ballantyne CM, Wu H. Dietary Effects on Monocyte Phenotypes in Subjects With Hypertriglyceridemia and Metabolic Syndrome. JACC Basic Transl Sci. 2023 Apr 26;8(5):460-475. doi: 10.1016/j.jacbts.2023.02.011. eCollection 2023 May.
PubMed 37325398
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diet Interventions on Monocyte Phenotypes in Individuals With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03591588
- Acronym / sponsor ID
- H21418
- Conditions
- Metabolic Syndrome, Hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 19 Jul 2018 (actual)
- 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.
Subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4 days (days 1-4) and a breakfast on day 5. Blood samples are collected on day 1 and day 5 to examine lipid levels and circulating monocyte phenotypes.
Detailed description
Subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4 days (days 1-4) and a breakfast on day 5. Blood samples are collected on day 1 at fasting state and on day 5 at fasting state and 4 and 6 hours after the breakfast to examine lipid levels and circulating monocyte phenotypes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study includes 2 types of diets, i.e., high-saturated fat diet and low-fat high-protein diet, in the same individuals with randomized crossover design.
| Arm | Type | Receives |
|---|---|---|
| high-saturated fat diet | Active comparator | Other: dietDiet high in saturated fat (~50% calorie from fat, ~25% from saturated fat) |
| low-fat diet | Active comparator | Other: dietDiet with low fat (~25% calorie from fat) |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obese women and men with metabolic syndrome (MS)
- Fasting triglyceride (TG) equal to or greater than 150 mg/dl
Key exclusion criteria (12 listed)
- <21 years of age
- Perimenopausal, pregnant or breastfeeding women
- Current smokers
- Obvious inflammation or other acute illnesses
- Obesity due to endocrinologic disorders including polycystic ovary syndrome
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 |
|---|---|---|
| dietThe study includes 2 types of diets, i.e., high-saturated fat diet and low-fat high-protein diet, which are provided to each participant in a randomized crossover design. | Other | high-saturated fat diet, low-fat diet |
Primary outcome
Effects of diet interventions on monocyte phenotypes
Time frame: 2016 to 2020
Monocyte phenotypes
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 8 Jul 2020.
- Derived from this study: PubMed 37325398Lian Z, Perrard XD, Antony AK, Peng X, Xu L, Ni J, Zhang B, O'Brien V, Saeed A, Jia X, Hussain A, Yu B, Simon SI, Sacks FM, Hoogeveen RC, Ballantyne CM, Wu H. Dietary Effects on Monocyte Phenotypes in Subjects With Hypertriglyceridemia and Metabolic Syndrome. JACC Basic Transl Sci. 2023 Apr 26;8(5):460-475. doi: 10.1016/j.jacbts.2023.02.011. eCollection 2023 May.
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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.
HUAIZHU WU, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet in people with Metabolic Syndrome and Hypertriglyceridemia, run by Baylor College of Medicine 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 2 inclusion and 12 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 8 Jul 2020. 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?
Effects of diet interventions on monocyte phenotypes (time frame: 2016 to 2020). 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 NCT03591588, which also lists 1 linked publication.
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 8 Jul 2020.