OverweightNCT04120220
Shake It Up: Lipidomics of Lipoproteins and Diet
A study testing Heavy Cream and Soybean Oil in people with Overweight, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of this research is to understand how dietary fat is related to cardiovascular disease (CVD). This study tests the effect of different dietary fats on the level of fat in the blood and the particles that transport fat in the blood. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Heavy Cream and Soybean Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2019to 20 May 2022
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal to overweight (BMI 18.0-29.9 kg/m^2
- Willing to comply with the demands of the experimental protocol
Who cannot join
- Inability to provide consent
- Have fasting blood glucose <60 mg/dL or >126 mg/dL
- Have fasting blood cholesterol >300 mg/dL
- Have fasting blood triglyceride <100 mg/dL or >300 mg/dL
- Have uncontrolled hypertension (blood pressure >140/90 mm Hg)
- Take prescription medications for blood sugar or lipid management or anti-inflammatory steroids (e.g. cortisone)
Show all 14Show fewer
- Over the counter use of supplements (fish oil, flax, plant sterol or sterol esters) and unwilling to discontinue use for 6 weeks prior to study initiation
- Have a history of an eating disorder, unusual dietary pattern (extreme nutrient or food group restriction; erratic meals due to shift work, etc.)
- Have established cardiovascular, pulmonary, and/or a metabolic disease such as diabetes
- Have cancer
- Use tobacco products or nicotine in any form including snuff, pills, and patches, or e-cigarettes/vaping in the past 6 weeks
- Have alcohol, anabolic steroids, or other substance abuse issues
- Consume more than 3 alcoholic drinks/week
- Are lactose intolerant or have an allergy to dairy foods
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
The purpose of this research is to understand how dietary fat is related to cardiovascular disease (CVD). This study tests the effect of different dietary fats on the level of fat in the blood and the particles that transport fat in the blood. The researchers want to know if these particles change after eating meals made with different fats.
Read the detailed description
The overall objective of this work is to discover how the lipidomic composition of postprandial lipoproteins responds to dietary fats of differing fatty acid composition by comparing meals rich in saturated fatty acid (SFA) (from dairy cream) versus polyunsaturated fatty acids (PUFA) (from soybean oil). The information derived from these studies will provide mechanistic insight into postprandial lipid metabolism and will support efforts to identify optimal dietary oil intakes for people.
- Conditions
- Overweight
- Being tested
- Heavy Cream, Soybean Oil
- Keywords
- Normal weight
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy CreamOther
Participants will receive a meal in the form of a fruit-containing shake containing 30 g of fat prepared with heavy cream.
Soybean OilOther
Participants will receive a meal in the form of a fruit-containing shake containing 30 g of fat prepared with soybean oil.
| Study group | Role | What they receive |
|---|---|---|
| Heavy Cream | Experimental | Participants will receive a meal containing 30 g of fat prepared with heavy cream. Receives: Other: Heavy Cream |
| Soybean Oil | Experimental | Participants will receive a meal containing 30 g of fat prepared with soybean oil. Receives: Other: Soybean Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lipidomic composition of plasma post-prandial lipoproteins as assessed by incremental area under the curve (iAUC)
Measured: 0, 1, 2, 4, 6, 8 hours post meal intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start12 Nov 2019
- Primary completion20 May 2022
- Study completion20 May 2022
Why it stopped: PI will be retiring from the Center. Research will not continue with a new PI.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew Picklo, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120220
- Sponsor's protocol ID
- GFHNRC511
- Status last verified
- Aug 2022
- First submitted
- 7 Oct 2019
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shake It Up: Lipidomics of Lipoproteins and Diet
- ClinicalTrials.gov ID
- NCT04120220
- Acronym / sponsor ID
- GFHNRC511
- Conditions
- Overweight
- Keywords
- Normal weight
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI will be retiring from the Center. Research will not continue with a new PI.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 9 Oct 2019 (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.
The purpose of this research is to understand how dietary fat is related to cardiovascular disease (CVD). This study tests the effect of different dietary fats on the level of fat in the blood and the particles that transport fat in the blood. The researchers want to know if these particles change after eating meals made with different fats.
Detailed description
The overall objective of this work is to discover how the lipidomic composition of postprandial lipoproteins responds to dietary fats of differing fatty acid composition by comparing meals rich in saturated fatty acid (SFA) (from dairy cream) versus polyunsaturated fatty acids (PUFA) (from soybean oil). The information derived from these studies will provide mechanistic insight into postprandial lipid metabolism and will support efforts to identify optimal dietary oil intakes for people.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy Cream | Experimental | Other: Heavy CreamParticipants will receive a meal containing 30 g of fat prepared with heavy cream. |
| Soybean Oil | Experimental | Other: Soybean OilParticipants will receive a meal containing 30 g of fat prepared with soybean oil. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal to overweight (BMI 18.0-29.9 kg/m^2
- Willing to comply with the demands of the experimental protocol
Key exclusion criteria (14 listed)
- Inability to provide consent
- Have fasting blood glucose <60 mg/dL or >126 mg/dL
- Have fasting blood cholesterol >300 mg/dL
- Have fasting blood triglyceride <100 mg/dL or >300 mg/dL
- Have uncontrolled hypertension (blood pressure >140/90 mm Hg)
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 |
|---|---|---|
| Heavy CreamParticipants will receive a meal in the form of a fruit-containing shake containing 30 g of fat prepared with heavy cream. | Other | Heavy Cream |
| Soybean OilParticipants will receive a meal in the form of a fruit-containing shake containing 30 g of fat prepared with soybean oil. | Other | Soybean Oil |
Primary outcome
Change in lipidomic composition of plasma post-prandial lipoproteins as assessed by incremental area under the curve (iAUC)
Time frame: 0, 1, 2, 4, 6, 8 hours post meal intake
Results and safety
The study was stopped early (reason given: PI will be retiring from the Center. Research will not continue with a new PI.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Grand Forks Human Nutrition Research Center Current Nutrition StudiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Matthew Picklo, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heavy Cream and Soybean Oil in people with Overweight, run by USDA Grand Forks Human Nutrition Research Center 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 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: stopped early, as of the sponsor's last update on 4 Aug 2022. 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 was stopped early (reason given: PI will be retiring from the Center. Research will not continue with a new PI.). Results are not available in the source record.
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 lipidomic composition of plasma post-prandial lipoproteins as assessed by incremental area under the curve (iAUC) (time frame: 0, 1, 2, 4, 6, 8 hours post meal intake). 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 4 Aug 2022.