Plasma Lipid ProfileNCT05589350
High-fat Yogurt and Plasma Lipids Profile
A study testing saturated fat intake in people with Plasma Lipid Profile, run by Shahid Beheshti University at 1 site in Iran.
Trial summary
The goal of this clinical trial is to compare the effect of saturated fat intake from different source on cardiometabolic risk markers in healthy subjects. The main question it aims to answer are: -Does intake of saturated fat in the form of high-fat yogurt have a different effect on cardiometabolic risk factors than… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasma Lipid Profile
- What is being tested?
- saturated fat intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 15 Oct 2022to 13 Apr 2023
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy people who do not use lipid-lowering, blood pressure control or diabetes medications
Who cannot join
- Taking supplements of omega-3 fatty acids, or antioxidants
Trial locations and contacts
1 site in 1 country.
Iran1 site
Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
Tehran, 19395-4741
About this study
Official title: Comparison of the Impact of Saturated Fat From High-fat Yogurt or Low-fat Yogurt and Butter on Cardiometabolic Risk Markers: a Randomized Cross-over Trial
The goal of this clinical trial is to compare the effect of saturated fat intake from different source on cardiometabolic risk markers in healthy subjects. The main question it aims to answer are:
-Does intake of saturated fat in the form of high-fat yogurt have a different effect on cardiometabolic risk factors than intake of the same amount from butter? In this study, in two periods of 4 weeks, the effect of receiving saturated fat from high-fat yogurt compared to receiving the same amount of saturated fat from butter and low-fat yogurt on the plasma concentration of lipids, cholesterol, insulin, and some inflammatory factors will be studied in healthy subjects.
- Conditions
- Plasma Lipid Profile
- Being tested
- saturated fat intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saturated fat intakeOther
Intake of saturated fat from yogurt and animal butter daily for 4-week period
| Study group | Role | What they receive |
|---|---|---|
| High-fat yogurt | Experimental | Daily consumption of 1-2 servings (based on daily calorie requirement) of high-fat yogurt Receives: Other: saturated fat intake |
| Low-fat yogurt and butter | Active comparator | Daily consumption of 1-2 servings of low-fat yogurt along with daily consumption of about 10 grams of animal butter Receives: Other: saturated fat intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma lipid profile
Plasma concentrations of cholesterol, high-density lipoprotein cholesterol, Low-density lipoprotein cholesterol, and triglyceride
Measured: 4 weeks
Secondary outcomes (1)
Glycemic measures
Fasting plasma concentrations of glucose and insulin
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start15 Oct 2022
- Primary completion13 Apr 2023
- Study completion13 Apr 2023
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 Plasma Lipid ProfileStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Nasrollahzadeh, Shahid Beheshti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589350
- Sponsor's protocol ID
- 32333
- Status last verified
- Apr 2023
- First submitted
- 15 Oct 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ranjbar YR, Nasrollahzadeh J. Comparison of the impact of saturated fat from full-fat yogurt or low-fat yogurt and butter on cardiometabolic factors: a randomized cross-over trial. Eur J Nutr. 2024 Jun;63(4):1213-1224. doi: 10.1007/s00394-024-03352-8. Epub 2024 Feb 17.
PubMed 38367032
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Impact of Saturated Fat From High-fat Yogurt or Low-fat Yogurt and Butter on Cardiometabolic Risk Markers: a Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT05589350
- Acronym / sponsor ID
- 32333
- Conditions
- Plasma Lipid Profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 21 Oct 2022 (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 goal of this clinical trial is to compare the effect of saturated fat intake from different source on cardiometabolic risk markers in healthy subjects. The main question it aims to answer are:
-Does intake of saturated fat in the form of high-fat yogurt have a different effect on cardiometabolic risk factors than intake of the same amount from butter? In this study, in two periods of 4 weeks, the effect of receiving saturated fat from high-fat yogurt compared to receiving the same amount of saturated fat from butter and low-fat yogurt on the plasma concentration of lipids, cholesterol, insulin, and some inflammatory factors will be studied in healthy subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-fat yogurt | Experimental | Other: saturated fat intakeDaily consumption of 1-2 servings (based on daily calorie requirement) of high-fat yogurt |
| Low-fat yogurt and butter | Active comparator | Other: saturated fat intakeDaily consumption of 1-2 servings of low-fat yogurt along with daily consumption of about 10 grams of animal butter |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy people who do not use lipid-lowering, blood pressure control or diabetes medications
Key exclusion criteria (1 listed)
- Taking supplements of omega-3 fatty acids, or antioxidants
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 |
|---|---|---|
| saturated fat intakeIntake of saturated fat from yogurt and animal butter daily for 4-week period | Other | High-fat yogurt, Low-fat yogurt and butter |
Primary outcome
Plasma lipid profile
Time frame: 4 weeks
Plasma concentrations of cholesterol, high-density lipoprotein cholesterol, Low-density lipoprotein cholesterol, and triglyceride
1 secondary outcome
Glycemic measures
Time frame: 4 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 18 Apr 2023.
- Derived from this study: PubMed 38367032Ranjbar YR, Nasrollahzadeh J. Comparison of the impact of saturated fat from full-fat yogurt or low-fat yogurt and butter on cardiometabolic factors: a randomized cross-over trial. Eur J Nutr. 2024 Jun;63(4):1213-1224. doi: 10.1007/s00394-024-03352-8. Epub 2024 Feb 17.
Related trials for Plasma Lipid Profile
Recruiting
Acute Effects of MCT Formulations on Beta-Hydroxybutyrate Response, Lipid Profile, and Glucose Levels in Healthy Adults
Ketone Body, Lipid Metabolism
Active, not recruiting
Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI
Myocardial Infarction
Not yet recruitingPhase 1/2
Impact of Chromium Supplementation on Glucido-lipidic Metabolism, Oxidative Stress and Inflammatory State in Patients with Gestational Diabetes
Gestational Diabetes Mellitus (GDM), Oxidative Stress
Not yet recruitingObservational study
Study on Lipid Profile Changes in Plasma and Intestinal Mucosa of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Diseases
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 saturated fat intake in people with Plasma Lipid Profile, run by Shahid Beheshti University at 1 site in Iran.
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 1 inclusion and 1 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 18 Apr 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 Iran. 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 lipid profile (time frame: 4 weeks). 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 NCT05589350, 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 18 Apr 2023.