Cardiovascular DiseaseNCT01427855
Dietary Protein Sources and Atherogenic Dyslipidemia
A study testing High saturated fat red meat diet, High saturated fat non-meat diet and High saturated fat white meat diet in people with Cardiovascular Disease and Dyslipidemia, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
Trial summary
There is growing epidemiological evidence that consumption of red meat is associated with greater incidence of Cardiovascular Disease (CVD) than either white meat or non-meat foods. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Dyslipidemia, Insulin Resistance
- What is being tested?
- High saturated fat red meat diet, High saturated fat non-meat diet and High saturated fat white meat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to May 2017
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30-65 years old
- Non-smoking
- Agrees to abstain from alcohol and dietary supplements during the study
- Willing to consume all study foods as instructed
Who cannot join
- History of heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, lung disease, diabetes, Human immunodeficiency virus (HIV), or cancer (other than skin cancer) in the last 5 years
- Body mass index (BMI) > 35 kg/m2 or < 20 kg/m2
- Not weight stable
- Abnormal thyroid stimulating hormone
- Blood pressure > 150/90
- Fasting blood sugar >126 mg/dl
Show all 10Show fewer
- Fasting triglyceride levels >500 mg/dl
- Total- and LDL cholesterol >95th percentile for age and sex
- Pregnant or breastfeeding
- Taking hormones or drugs known to affect lipid metabolism
Trial locations and contacts
1 site in 1 country.
United States1 site
Cholesterol Research Center, Children's Hospital Research Institute
Berkeley, California, 94705
About this study
Official title: Saturated Fat and Protein Effects on Atherogenic Dyslipidemia
There is growing epidemiological evidence that consumption of red meat is associated with greater incidence of Cardiovascular Disease (CVD) than either white meat or non-meat foods. Research from our group has shown that a high saturated fat (SF) diet with a moderate red meat content selectively increases intermediate density lipoproteins (IDL) and larger low density lipoproteins (LDLs), which are more weakly associated with CVD risk than smaller LDLs. In contrast, the investigators have found that with a similar intake of SF, high beef consumption results in a preferential increase in small and medium LDL particles that are strongly related to CVD. To date, no studies have directly compared the lipoprotein effects of red meat with that of other food sources of protein in the context of both high and low saturated fat intake.
The overall objective of this project is to test the hypothesis that the effects of SF on lipoprotein markers of CVD risk are influenced by sources of dietary protein. The investigators hypothesize that adverse effects of SF on plasma levels of LDL-cholesterol (C), apolipoprotein B (apo B), and atherogenic LDL particles are greater in a diet with a high content of red meat than in diets in which the major proteins are from white meat (poultry) or non-meat sources. The investigators propose a clinical trial in which 180 healthy men and women will be randomized to high SF or low SF diet groups, and within each group, consume diets with equivalent amounts of protein from red meat, white meat, and non-meat sources for 4 wks each in random order. Specifically, the investigators will test whether: (1) With high SF, the red meat diet, compared to the other protein sources, will result in higher levels of LDL-C, apoB, small and medium LDL, and total/high density lipoprotein (HDL)C; (2) With low SF, dietary protein source will not be related to any of these measurements; (3) With both the white meat and non-meat protein diets, increased LDL-C with high vs. low SF will be due primarily to increases in large LDL, whereas with red meat the additional increase in small and medium LDL will result in greater increases in plasma apoB and total LDL particle number. Aim 4 will test hypotheses that increases in small and medium LDL with high SF plus red meat are related to increased activity of hepatic lipase, a key determinant of small LDL production, and that increases in large LDL induced by high SF are related to suppression of LDL receptors. The investigators will also assess the effects of protein source and saturated fat content on markers of insulin resistance, inflammation and endothelial function.
Read the detailed description
Clinic Visits:
Participants will visit the clinic a total of 11 times from screen to completion of study. This will include weekly visits with the nutritionist and 9 visits requiring blood draws (at screen and on 2 consecutive visits after each dietary period). At each visit, participants will be weighed, waist and hip circumference will be measured and blood pressure will be monitored. The total amount of blood collected during the course of the study will be 455 mL.
Screening visit (SV: 1 hour):
Recruiters will initially determine eligibility through review of a screening questionnaire and a telephone or personal interview. If a potential subject is eligible and interested, an orientation package will be mailed that will include written information about the study requirements. Interested individuals passing pre-screening will be scheduled for a screening blood draw visit to determine final eligibility. At the screening visit (SV), participants will give informed consent, review their medical history with a registered nurse, and have their blood pressure, weight, height, and waist and hip circumference measured. Thirty ml of blood will be drawn for measurement of plasma triglycerides (TG), total-C, LDL-C, HDL-C, glucose and thyroid stimulating hormone (TSH). Women of childbearing potential will be given a beta-Human Chorionic Gonadotropin (b-hCG) urine pregnancy test. Participants will be contacted within 2 weeks to notify them of their eligibility.
Nutritionist Visits (Initial: 1 hr):
Participants will meet weekly with a nutritionist to receive counseling including weight management and diet review. At these meetings, participants will receive a week's worth of frozen entrees and study foods, as well as standardized menus with check lists. During the washout period (weeks 6-8; weeks 12-14), subjects will continue to refrain from alcohol but will consume their usual home diet for 14 days.
Post-diet Visits Requiring Blood Draws (A visits: 1.5 hr, B visits: 2.5 hr):
Participants will visit the clinic on two separate days following completion of each diet to provide blood samples. Duplicate sampling reduces biological variability, and hence improves the power of the study to detect significant diet-induced changes in measurement. On the penultimate day of each diet (visits 1A, 2A, 3A, 4A) a fasting blood draw (45 mL) will be taken for plasma measurements (TG, total-C, LDL-C, HDL-C, lipoprotein subfractions, glucose, insulin, apolipoproteins AI, AII, B, and CIII, and inflammatory markers). On the last day of each dietary period (visits 1B, 2B, 3B, 4B) participants will provide a second fasting blood sample (for lipids and lipoproteins as above). Lipoprotein lipase and hepatic lipase activities will also be measured in plasma (20mL) collected 15 minutes after intravenous heparin (75 units/kg).
Clinical Procedures:
Clinical measurements: Blood pressure will be measured 3 times in a sitting position and the last 2 values averaged. Anthropometric measurements include height, weight, waist and hip circumference, and % body fat by bioimpedance (Tanita scale). Waist circumference is measured two times at the iliac crest and hip circumference is measured at the widest point of the hips.
Standard Blood sampling: Using standard blood collection procedures, blood samples will be collected from participants after a 12-14 hour fast. The blood will be collected into tubes containing the following preservative solution: 3.0 gms EDTA (dipotassium), 1.7 mg P-Pack, 0.15 gms gentamycin sulfate, 0.15 gms chloramphenicol, 5.96 mls aprotinin (Sigma A-6279), and 0.30 gms sodium azide all of which are diluted to 20mls with doubly deionized water. Plasma is separated by immediate centrifugation at 4°C. Lipid and lipoprotein measurements are performed and aliquots of plasma are frozen for future analyses.
Post-heparin Blood Sampling: A blood sample (20ml) will be drawn 15 minutes after intravenous administration of a heparin bolus (75 U/kg, see Risk section for justification) for the analysis of plasma lipase activity. Prior to administration, participants will be interviewed for family history of clotting disorders or personal contraindications including use of anticoagulants, history of bleeding or bruising abnormalities or other diseases, allergies, or recent dental work. Following administration, participants will remain in clinic for 2 hours under observation. They will also be provided with an information sheet regarding heparin and the procedure.
Measurement of endothelial function: Endothelial function will be assessed in the fasting state by finger reactive hyperemia peripheral arterial tonometry (RH-PAT, Endo-Pat2000, Itamar Medical, Israel) and expressed as RH-PAT index. Participants will rest in a supine position in a quiet, temperature-controlled room for 30 min. prior to PAT measurements and will abstain from caffeine for 6 hours and from water for 2 hours prior to the test, per manufacturer's guidelines.
- Conditions
- Cardiovascular Disease, Dyslipidemia, Insulin Resistance, Inflammation
- Being tested
- High saturated fat red meat diet, High saturated fat non-meat diet, High saturated fat white meat diet, Low saturated fat red meat diet, Low saturated fat white meat diet
- Keywords
- Dietary Protein, Red Meat, White Meat, Vegetable Protein, Saturated Fat, LDL Subclasses, Cholesterol, Atherogenic Dyslipidemia
- Medical subject headings
- Cardiovascular Diseases, Dyslipidemias, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High saturated fat red meat dietOther
4 weeks of a high saturated fat red meat diet (38% carbohydrate; 25% protein (12% kcal from red meat protein); 37% fat (15% kcal from saturated fat))
High saturated fat non-meat dietOther
4 weeks of a high saturated fat non-meat diet (38% carbohydrate; 25% protein (16% kcal from non-meat protein); 37% fat (15% kcal from saturated fat))
High saturated fat white meat dietOther
4 weeks of a high saturated fat white meat diet (38% carbohydrate; 25% protein (12% kcal from white meat protein); 37% fat (15% kcal from saturated fat))
Low saturated fat red meat dietOther
4 weeks of a low saturated fat red meat diet (38% carbohydrate; 25% protein (12% kcal from red meat protein); 37% fat (7% kcal from saturated fat))
Low saturated fat white meat dietOther
4 weeks of a low saturated fat white meat diet (38% carbohydrate; 25% protein (12% kcal from white meat protein); 37% fat (7% kcal from saturated fat))
Low saturated fat non meat dietOther
4 weeks of a low saturated fat non-meat diet (38% carbohydrate; 25% protein (16% kcal from non-meat protein); 37% fat (7% kcal from saturated fat))
| Study group | Role | What they receive |
|---|---|---|
| High Saturated Fat Red Meat Diet | Experimental | Not described Receives: Other: High saturated fat red meat diet |
| High Saturated Fat White Meat Diet | Experimental | Not described Receives: Other: High saturated fat white meat diet |
| High Saturated Fat Non-Meat Diet | Experimental | Not described Receives: Other: High saturated fat non-meat diet |
| Low Saturated Fat Red Meat Diet | Experimental | Not described Receives: Other: Low saturated fat red meat diet |
| Low Saturated Fat White Meat Diet | Experimental | Not described Receives: Other: Low saturated fat white meat diet |
| Low Saturated Fat Non-Meat Diet | Experimental | Not described Receives: Other: Low saturated fat non meat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in LDL-Cholesterol
Measured: 6 weeks, 12 weeks, 18 weeks
Change from baseline in ApoB
Measured: 6 weeks, 12 weeks, 18 weeks
Change from baseline in Small + Medium Sized LDL
Measured: 6 weeks, 12 weeks, 18 weeks
Change from baseline in Total Cholesterol/HDL Cholesterol ratio
Measured: 6 weeks, 12 weeks, 18 weeks
Secondary outcomes (12)
Change from baseline in HDL-Cholesterol
Measured: 6 weeks, 12 weeks, 18 weeks
Change from baseline in non-HDLC
Measured: 6 weeks, 12 weeks, 18 weeks
Change from baseline in apoAI
Measured: 6 weeks, 12 weeks, 18 weeks
Change from baseline in apoAII
Measured: 6 weeks, 12 weeks, 18 weeks
Change from baseline in HDL2 Cholesterol
Measured: 6 weeks, 12 weeks, 18 weeks
Change from baseline in HDL3 Cholesterol
Measured: 6 weeks, 12 weeks, 18 weeks
Change from baseline in homeostasis model assessment-insulin resistance (HOMA-IR)
Measured: 6 weeks, 12 weeks, 18 weeks
Change from baseline in C-Reactive Protein
Measured: 6 weeks, 12 weeks, 18 weeks
Change from baseline in Tumor Necrosis Factor-alpha
Measured: 6 weeks, 12 weeks, 18 weeks
Change from baseline in Interleukin-6
Measured: 6 weeks, 12 weeks, 18 weeks
Change from baseline in Monocyte Chemotactic Protein-1 (MCP-1)
Measured: 6 weeks, 12 weeks, 18 weeks
Change from baseline in RH-PAT index
Measured: 6 weeks, 12 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionNov 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ronald M Krauss, MD, Principal investigator, UCSF Benioff Children's Hospital OaklandNathalie Bergeron, PhD, Principal investigator, Children's Hospital Oakland Research Institiute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427855
- Sponsor's protocol ID
- 1R01HL106003-01A1
- Other IDs
- 1R01HL106003-01A1
- Status last verified
- Nov 2020
- First submitted
- 31 Aug 2011
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gadgil MD, Stroebel BM, King SM, Bergeron N, Chiu S, Krauss RM. Effects of Protein Source and Amount of Saturated Fat on Insulin Sensitivity, Insulin Secretion, and Disposition Index in Healthy Individuals. J Nutr. 2026 May;156(5):101458. doi: 10.1016/j.tjnut.2026.101458. Epub 2026 Mar 2.
PubMed 41780824Ferrell M, Bazeley P, Wang Z, Levison BS, Li XS, Jia X, Krauss RM, Knight R, Lusis AJ, Garcia-Garcia JC, Hazen SL, Tang WHW. Fecal Microbiome Composition Does Not Predict Diet-Induced TMAO Production in Healthy Adults. J Am Heart Assoc. 2021 Nov 2;10(21):e021934. doi: 10.1161/JAHA.121.021934. Epub 2021 Oct 29.
PubMed 34713713Bergeron N, Chiu S, Williams PT, M King S, Krauss RM. Effects of red meat, white meat, and nonmeat protein sources on atherogenic lipoprotein measures in the context of low compared with high saturated fat intake: a randomized controlled trial. Am J Clin Nutr. 2019 Jul 1;110(1):24-33. doi: 10.1093/ajcn/nqz035.
PubMed 31161217
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saturated Fat and Protein Effects on Atherogenic Dyslipidemia
- ClinicalTrials.gov ID
- NCT01427855
- Acronym / sponsor ID
- 1R01HL106003-01A1
- Conditions
- Cardiovascular Disease, Dyslipidemia, Insulin Resistance, Inflammation
- Keywords
- Dietary Protein, Red Meat, White Meat, Vegetable Protein, Saturated Fat, LDL Subclasses, Cholesterol, Atherogenic Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2012 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 2 Sep 2011 (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.
There is growing epidemiological evidence that consumption of red meat is associated with greater incidence of Cardiovascular Disease (CVD) than either white meat or non-meat foods. Research from our group has shown that a high saturated fat (SF) diet with a moderate red meat content selectively increases intermediate density lipoproteins (IDL) and larger low density lipoproteins (LDLs), which are more weakly associated with CVD risk than smaller LDLs. In contrast, the investigators have found that with a similar intake of SF, high beef consumption results in a preferential increase in small and medium LDL particles that are strongly related to CVD. To date, no studies have directly compared the lipoprotein effects of red meat with that of other food sources of protein in the context of both high and low saturated fat intake.
The overall objective of this project is to test the hypothesis that the effects of SF on lipoprotein markers of CVD risk are influenced by sources of dietary protein. The investigators hypothesize that adverse effects of SF on plasma levels of LDL-cholesterol (C), apolipoprotein B (apo B), and atherogenic LDL particles are greater in a diet with a high content of red meat than in diets in which the major proteins are from white meat (poultry) or non-meat sources. The investigators propose a clinical trial in which 180 healthy men and women will be randomized to high SF or low SF diet groups, and within each group, consume diets with equivalent amounts of protein from red meat, white meat, and non-meat sources for 4 wks each in random order. Specifically, the investigators will test whether: (1) With high SF, the red meat diet, compared to the other protein sources, will result in higher levels of LDL-C, apoB, small and medium LDL, and total/high density lipoprotein (HDL)C; (2) With low SF, dietary protein source will not be related to any of these measurements; (3) With both the white meat and non-meat protein diets, increased LDL-C with high vs. low SF will be due primarily to increases in large LDL, whereas with red meat the additional increase in small and medium LDL will result in greater increases in plasma apoB and total LDL particle number. Aim 4 will test hypotheses that increases in small and medium LDL with high SF plus red meat are related to increased activity of hepatic lipase, a key determinant of small LDL production, and that increases in large LDL induced by high SF are related to suppression of LDL receptors. The investigators will also assess the effects of protein source and saturated fat content on markers of insulin resistance, inflammation and endothelial function.
Detailed description
Clinic Visits:
Participants will visit the clinic a total of 11 times from screen to completion of study. This will include weekly visits with the nutritionist and 9 visits requiring blood draws (at screen and on 2 consecutive visits after each dietary period). At each visit, participants will be weighed, waist and hip circumference will be measured and blood pressure will be monitored. The total amount of blood collected during the course of the study will be 455 mL.
Screening visit (SV: 1 hour):
Recruiters will initially determine eligibility through review of a screening questionnaire and a telephone or personal interview. If a potential subject is eligible and interested, an orientation package will be mailed that will include written information about the study requirements. Interested individuals passing pre-screening will be scheduled for a screening blood draw visit to determine final eligibility. At the screening visit (SV), participants will give informed consent, review their medical history with a registered nurse, and have their blood pressure, weight, height, and waist and hip circumference measured. Thirty ml of blood will be drawn for measurement of plasma triglycerides (TG), total-C, LDL-C, HDL-C, glucose and thyroid stimulating hormone (TSH). Women of childbearing potential will be given a beta-Human Chorionic Gonadotropin (b-hCG) urine pregnancy test. Participants will be contacted within 2 weeks to notify them of their eligibility.
Nutritionist Visits (Initial: 1 hr):
Participants will meet weekly with a nutritionist to receive counseling including weight management and diet review. At these meetings, participants will receive a week's worth of frozen entrees and study foods, as well as standardized menus with check lists. During the washout period (weeks 6-8; weeks 12-14), subjects will continue to refrain from alcohol but will consume their usual home diet for 14 days.
Post-diet Visits Requiring Blood Draws (A visits: 1.5 hr, B visits: 2.5 hr):
Participants will visit the clinic on two separate days following completion of each diet to provide blood samples. Duplicate sampling reduces biological variability, and hence improves the power of the study to detect significant diet-induced changes in measurement. On the penultimate day of each diet (visits 1A, 2A, 3A, 4A) a fasting blood draw (45 mL) will be taken for plasma measurements (TG, total-C, LDL-C, HDL-C, lipoprotein subfractions, glucose, insulin, apolipoproteins AI, AII, B, and CIII, and inflammatory markers). On the last day of each dietary period (visits 1B, 2B, 3B, 4B) participants will provide a second fasting blood sample (for lipids and lipoproteins as above). Lipoprotein lipase and hepatic lipase activities will also be measured in plasma (20mL) collected 15 minutes after intravenous heparin (75 units/kg).
Clinical Procedures:
Clinical measurements: Blood pressure will be measured 3 times in a sitting position and the last 2 values averaged. Anthropometric measurements include height, weight, waist and hip circumference, and % body fat by bioimpedance (Tanita scale). Waist circumference is measured two times at the iliac crest and hip circumference is measured at the widest point of the hips.
Standard Blood sampling: Using standard blood collection procedures, blood samples will be collected from participants after a 12-14 hour fast. The blood will be collected into tubes containing the following preservative solution: 3.0 gms EDTA (dipotassium), 1.7 mg P-Pack, 0.15 gms gentamycin sulfate, 0.15 gms chloramphenicol, 5.96 mls aprotinin (Sigma A-6279), and 0.30 gms sodium azide all of which are diluted to 20mls with doubly deionized water. Plasma is separated by immediate centrifugation at 4°C. Lipid and lipoprotein measurements are performed and aliquots of plasma are frozen for future analyses.
Post-heparin Blood Sampling: A blood sample (20ml) will be drawn 15 minutes after intravenous administration of a heparin bolus (75 U/kg, see Risk section for justification) for the analysis of plasma lipase activity. Prior to administration, participants will be interviewed for family history of clotting disorders or personal contraindications including use of anticoagulants, history of bleeding or bruising abnormalities or other diseases, allergies, or recent dental work. Following administration, participants will remain in clinic for 2 hours under observation. They will also be provided with an information sheet regarding heparin and the procedure.
Measurement of endothelial function: Endothelial function will be assessed in the fasting state by finger reactive hyperemia peripheral arterial tonometry (RH-PAT, Endo-Pat2000, Itamar Medical, Israel) and expressed as RH-PAT index. Participants will rest in a supine position in a quiet, temperature-controlled room for 30 min. prior to PAT measurements and will abstain from caffeine for 6 hours and from water for 2 hours prior to the test, per manufacturer's guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| High Saturated Fat Red Meat Diet | Experimental | Other: High saturated fat red meat diet |
| High Saturated Fat White Meat Diet | Experimental | Other: High saturated fat white meat diet |
| High Saturated Fat Non-Meat Diet | Experimental | Other: High saturated fat non-meat diet |
| Low Saturated Fat Red Meat Diet | Experimental | Other: Low saturated fat red meat diet |
| Low Saturated Fat White Meat Diet | Experimental | Other: Low saturated fat white meat diet |
| Low Saturated Fat Non-Meat Diet | Experimental | Other: Low saturated fat non meat diet |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 30-65 years old
- Non-smoking
- Agrees to abstain from alcohol and dietary supplements during the study
- Willing to consume all study foods as instructed
Key exclusion criteria (10 listed)
- History of heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, lung disease, diabetes, Human immunodeficiency virus (HIV), or cancer (other than skin cancer) in the last 5 years
- Body mass index (BMI) > 35 kg/m2 or < 20 kg/m2
- Not weight stable
- Abnormal thyroid stimulating hormone
- Blood pressure > 150/90
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 |
|---|---|---|
| High saturated fat red meat diet4 weeks of a high saturated fat red meat diet (38% carbohydrate; 25% protein (12% kcal from red meat protein); 37% fat (15% kcal from saturated fat)) | Other | High Saturated Fat Red Meat Diet |
| High saturated fat non-meat diet4 weeks of a high saturated fat non-meat diet (38% carbohydrate; 25% protein (16% kcal from non-meat protein); 37% fat (15% kcal from saturated fat)) | Other | High Saturated Fat Non-Meat Diet |
| High saturated fat white meat diet4 weeks of a high saturated fat white meat diet (38% carbohydrate; 25% protein (12% kcal from white meat protein); 37% fat (15% kcal from saturated fat)) | Other | High Saturated Fat White Meat Diet |
| Low saturated fat red meat diet4 weeks of a low saturated fat red meat diet (38% carbohydrate; 25% protein (12% kcal from red meat protein); 37% fat (7% kcal from saturated fat)) | Other | Low Saturated Fat Red Meat Diet |
| Low saturated fat white meat diet4 weeks of a low saturated fat white meat diet (38% carbohydrate; 25% protein (12% kcal from white meat protein); 37% fat (7% kcal from saturated fat)) | Other | Low Saturated Fat White Meat Diet |
| Low saturated fat non meat diet4 weeks of a low saturated fat non-meat diet (38% carbohydrate; 25% protein (16% kcal from non-meat protein); 37% fat (7% kcal from saturated fat)) | Other | Low Saturated Fat Non-Meat Diet |
Primary outcome
Change from baseline in LDL-Cholesterol
Time frame: 6 weeks, 12 weeks, 18 weeks
Change from baseline in ApoB
Time frame: 6 weeks, 12 weeks, 18 weeks
Change from baseline in Small + Medium Sized LDL
Time frame: 6 weeks, 12 weeks, 18 weeks
Change from baseline in Total Cholesterol/HDL Cholesterol ratio
Time frame: 6 weeks, 12 weeks, 18 weeks
12 secondary outcomes
Change from baseline in HDL-Cholesterol
Time frame: 6 weeks, 12 weeks, 18 weeks
Change from baseline in non-HDLC
Time frame: 6 weeks, 12 weeks, 18 weeks
Change from baseline in apoAI
Time frame: 6 weeks, 12 weeks, 18 weeks
Change from baseline in apoAII
Time frame: 6 weeks, 12 weeks, 18 weeks
Change from baseline in HDL2 Cholesterol
Time frame: 6 weeks, 12 weeks, 18 weeks
Change from baseline in HDL3 Cholesterol
Time frame: 6 weeks, 12 weeks, 18 weeks
Change from baseline in homeostasis model assessment-insulin resistance (HOMA-IR)
Time frame: 6 weeks, 12 weeks, 18 weeks
Change from baseline in C-Reactive Protein
Time frame: 6 weeks, 12 weeks, 18 weeks
Change from baseline in Tumor Necrosis Factor-alpha
Time frame: 6 weeks, 12 weeks, 18 weeks
Change from baseline in Interleukin-6
Time frame: 6 weeks, 12 weeks, 18 weeks
Change from baseline in Monocyte Chemotactic Protein-1 (MCP-1)
Time frame: 6 weeks, 12 weeks, 18 weeks
Change from baseline in RH-PAT index
Time frame: 6 weeks, 12 weeks, 18 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 24 Nov 2020.
- Derived from this study: PubMed 41780824Gadgil MD, Stroebel BM, King SM, Bergeron N, Chiu S, Krauss RM. Effects of Protein Source and Amount of Saturated Fat on Insulin Sensitivity, Insulin Secretion, and Disposition Index in Healthy Individuals. J Nutr. 2026 May;156(5):101458. doi: 10.1016/j.tjnut.2026.101458. Epub 2026 Mar 2.
- Derived from this study: PubMed 34713713Ferrell M, Bazeley P, Wang Z, Levison BS, Li XS, Jia X, Krauss RM, Knight R, Lusis AJ, Garcia-Garcia JC, Hazen SL, Tang WHW. Fecal Microbiome Composition Does Not Predict Diet-Induced TMAO Production in Healthy Adults. J Am Heart Assoc. 2021 Nov 2;10(21):e021934. doi: 10.1161/JAHA.121.021934. Epub 2021 Oct 29.
- Derived from this study: PubMed 31161217Bergeron N, Chiu S, Williams PT, M King S, Krauss RM. Effects of red meat, white meat, and nonmeat protein sources on atherogenic lipoprotein measures in the context of low compared with high saturated fat intake: a randomized controlled trial. Am J Clin Nutr. 2019 Jul 1;110(1):24-33. doi: 10.1093/ajcn/nqz035.
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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.
Ronald M Krauss, MD principal investigator
UCSF Benioff Children's Hospital Oakland
Nathalie Bergeron, PhD principal investigator
Children's Hospital Oakland Research Institiute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High saturated fat red meat diet, High saturated fat non-meat diet and High saturated fat white meat diet in people with Cardiovascular Disease and Dyslipidemia, run by UCSF Benioff Children's Hospital Oakland 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 4 inclusion and 10 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 24 Nov 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?
Change from baseline in LDL-Cholesterol (time frame: 6 weeks, 12 weeks, 18 weeks). The study lists 4 primary outcomes in all. 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 NCT01427855, which also lists 3 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 24 Nov 2020.