Trial Outcomes & Findings for Impact of Beef on Metabolites and Inflammation (NCT NCT05460754)
NCT ID: NCT05460754
Last Updated: 2024-09-19
Results Overview
Concentration of postprandial serum triglycerides, high-density lipoproteins, cholesterol (mM)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
1 day
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Organic Grass-fed Beef, Then Conventional-fed Beef
Participants receive an organic grass-fed steak meal in the morning. After a washout period of at least 7 days, they then receive the alternative meal, conventional-fed steak meal in the morning.
Conventional-fed beef: Participants in the conventional-fed treatment of the study will consume a conventional-fed steak meal for breakfast one morning.
Organic grass-fed beef: Participants in the organic grass-fed treatment of the study will consume a organic grass-fed steak meal for breakfast one morning.
|
Conventional-fed Beef, Then Organic Grass-fed Beef
Participants receive a conventional-fed steak meal in the morning. After a washout period of at least 7 days, they then receive the alternative meal, an organic grass-fed steak meal in the morning.
Conventional-fed beef: Participants in the conventional-fed treatment of the study will consume a conventional-fed steak meal for breakfast one morning.
Organic grass-fed beef: Participants in the organic grass-fed treatment of the study will consume a organic grass-fed steak meal for breakfast one morning.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Beef on Metabolites and Inflammation
Baseline characteristics by cohort
| Measure |
Organic Grass-fed Beef, Then Conventional-fed Beef
n=5 Participants
Participants receive an organic grass-fed steak meal in the morning. After a washout period of at least 7 days, they then receive the alternative meal, conventional-fed steak meal in the morning.
Conventional-fed beef: Participants in the conventional-fed treatment of the study will consume a conventional-fed steak meal for breakfast one morning.
Organic grass-fed beef: Participants in the organic grass-fed treatment of the study will consume a organic grass-fed steak meal for breakfast one morning.
|
Conventional-fed Beef, Then Organic Grass-fed Beef
n=5 Participants
Participants receive a conventional-fed steak meal in the morning. After a washout period of at least 7 days, they then receive the alternative meal, an organic grass-fed steak meal in the morning.
Conventional-fed beef: Participants in the conventional-fed treatment of the study will consume a conventional-fed steak meal for breakfast one morning.
Organic grass-fed beef: Participants in the organic grass-fed treatment of the study will consume a organic grass-fed steak meal for breakfast one morning.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.6 years
STANDARD_DEVIATION 2.7 • n=99 Participants
|
29 years
STANDARD_DEVIATION 7.31 • n=107 Participants
|
26.3 years
STANDARD_DEVIATION 5.93 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 dayConcentration of postprandial serum triglycerides, high-density lipoproteins, cholesterol (mM)
Outcome measures
| Measure |
Organic Grass-fed Beef
n=10 Participants
Participants receive an organic grass-fed steak meal in the morning. After a washout period of at least 7 days, they then receive the alternative meal, conventional-fed steak meal in the morning.
Organic grass-fed beef: Participants in the organic grass-fed treatment of the study will consume a organic grass-fed steak meal for breakfast one morning.
|
Conventional-fed Beef
n=10 Participants
Participants receive a conventional-fed steak meal in the morning. After a washout period of at least 7 days, they then receive the alternative meal, an organic grass-fed steak meal in the morning.
Conventional-fed beef: Participants in the conventional-fed treatment of the study will consume a conventional-fed steak meal for breakfast one morning.
|
|---|---|---|
|
Postprandial Serum Lipids
HDL Hour 0
|
1.46 mmol/L
Standard Deviation 0.21
|
1.38 mmol/L
Standard Deviation 0.16
|
|
Postprandial Serum Lipids
Cholesterol Hour 1
|
3.97 mmol/L
Standard Deviation 1.023
|
3.84 mmol/L
Standard Deviation 0.80
|
|
Postprandial Serum Lipids
Cholesterol Hour 4
|
3.85 mmol/L
Standard Deviation 1.06
|
3.84 mmol/L
Standard Deviation 0.78
|
|
Postprandial Serum Lipids
Triglycerides Hour 0
|
1.01 mmol/L
Standard Deviation 0.48
|
0.94 mmol/L
Standard Deviation 0.43
|
|
Postprandial Serum Lipids
Triglycerides Hour 1
|
0.99 mmol/L
Standard Deviation 0.52
|
0.97 mmol/L
Standard Deviation 0.43
|
|
Postprandial Serum Lipids
Triglycerides Hour 2
|
1.009 mmol/L
Standard Deviation 0.53
|
1.09 mmol/L
Standard Deviation 0.48
|
|
Postprandial Serum Lipids
Triglycerides Hour 3
|
1.14 mmol/L
Standard Deviation 0.61
|
1.27 mmol/L
Standard Deviation 0.71
|
|
Postprandial Serum Lipids
Triglycerides Hour 4
|
1.16 mmol/L
Standard Deviation 0.62
|
1.26 mmol/L
Standard Deviation 0.69
|
|
Postprandial Serum Lipids
HDL Hour 1
|
1.45 mmol/L
Standard Deviation 0.16
|
1.41 mmol/L
Standard Deviation 0.17
|
|
Postprandial Serum Lipids
HDL Hour 2
|
1.46 mmol/L
Standard Deviation 0.23
|
1.38 mmol/L
Standard Deviation 0.13
|
|
Postprandial Serum Lipids
HDL Hour 3
|
1.46 mmol/L
Standard Deviation 0.19
|
1.39 mmol/L
Standard Deviation 0.17
|
|
Postprandial Serum Lipids
HDL Hour 4
|
1.45 mmol/L
Standard Deviation 0.21
|
1.37 mmol/L
Standard Deviation 0.16
|
|
Postprandial Serum Lipids
Cholesterol Hour 0
|
3.92 mmol/L
Standard Deviation 1.04
|
3.74 mmol/L
Standard Deviation 0.76
|
|
Postprandial Serum Lipids
Cholesterol Hour 2
|
3.97 mmol/L
Standard Deviation 1.08
|
3.81 mmol/L
Standard Deviation 0.85
|
|
Postprandial Serum Lipids
Cholesterol Hour 3
|
3.97 mmol/L
Standard Deviation 1.06
|
3.84 mmol/L
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: 1 dayConcentration of postprandial serum inflammatory cytokine responses (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor; all in pg/ml)
Outcome measures
| Measure |
Organic Grass-fed Beef
n=10 Participants
Participants receive an organic grass-fed steak meal in the morning. After a washout period of at least 7 days, they then receive the alternative meal, conventional-fed steak meal in the morning.
Organic grass-fed beef: Participants in the organic grass-fed treatment of the study will consume a organic grass-fed steak meal for breakfast one morning.
|
Conventional-fed Beef
n=10 Participants
Participants receive a conventional-fed steak meal in the morning. After a washout period of at least 7 days, they then receive the alternative meal, an organic grass-fed steak meal in the morning.
Conventional-fed beef: Participants in the conventional-fed treatment of the study will consume a conventional-fed steak meal for breakfast one morning.
|
|---|---|---|
|
Postprandial Serum Inflammatory Cytokines
IL-6 Hour 2
|
8.73 pg/ml
Standard Deviation 11.46
|
6.90 pg/ml
Standard Deviation 7.41
|
|
Postprandial Serum Inflammatory Cytokines
IL-17 Hour 0
|
76.02 pg/ml
Standard Deviation 31.58
|
77.59 pg/ml
Standard Deviation 36.29
|
|
Postprandial Serum Inflammatory Cytokines
IL-17 Hour 1
|
80.16 pg/ml
Standard Deviation 33.65
|
81.01 pg/ml
Standard Deviation 44.62
|
|
Postprandial Serum Inflammatory Cytokines
IL-17 Hour 2
|
82.41 pg/ml
Standard Deviation 40.20
|
78.43 pg/ml
Standard Deviation 31.96
|
|
Postprandial Serum Inflammatory Cytokines
IL-17 Hour 3
|
74.20 pg/ml
Standard Deviation 34.27
|
86.14 pg/ml
Standard Deviation 39.63
|
|
Postprandial Serum Inflammatory Cytokines
INF Hour 1
|
376.34 pg/ml
Standard Deviation 264.81
|
402.29 pg/ml
Standard Deviation 318.26
|
|
Postprandial Serum Inflammatory Cytokines
INF Hour 2
|
391.97 pg/ml
Standard Deviation 298.69
|
357.08 pg/ml
Standard Deviation 214.32
|
|
Postprandial Serum Inflammatory Cytokines
INF Hour 3
|
354.88 pg/ml
Standard Deviation 249.63
|
399.32 pg/ml
Standard Deviation 287.39
|
|
Postprandial Serum Inflammatory Cytokines
INF Hour 4
|
375.96 pg/ml
Standard Deviation 282.53
|
405.13 pg/ml
Standard Deviation 316.27
|
|
Postprandial Serum Inflammatory Cytokines
GMCSF Hour 0
|
67.14 pg/ml
Standard Deviation 38.25
|
64.29 pg/ml
Standard Deviation 37.73
|
|
Postprandial Serum Inflammatory Cytokines
GMCSF Hour 1
|
61.46 pg/ml
Standard Deviation 34.62
|
59.62 pg/ml
Standard Deviation 33.01
|
|
Postprandial Serum Inflammatory Cytokines
GMCSF Hour 2
|
58.72 pg/ml
Standard Deviation 30.09
|
59.76 pg/ml
Standard Deviation 35.88
|
|
Postprandial Serum Inflammatory Cytokines
GMCSF Hour 3
|
57.47 pg/ml
Standard Deviation 32.08
|
60.98 pg/ml
Standard Deviation 32.21
|
|
Postprandial Serum Inflammatory Cytokines
GMCSF Hour 4
|
58.86 pg/ml
Standard Deviation 38.67
|
61.99 pg/ml
Standard Deviation 34.27
|
|
Postprandial Serum Inflammatory Cytokines
TNFa Hour 0
|
17.84 pg/ml
Standard Deviation 5.57
|
17.65 pg/ml
Standard Deviation 5.92
|
|
Postprandial Serum Inflammatory Cytokines
TNFa Hour 1
|
17.62 pg/ml
Standard Deviation 5.37
|
17.69 pg/ml
Standard Deviation 6.12
|
|
Postprandial Serum Inflammatory Cytokines
TNFa Hour 2
|
18.35 pg/ml
Standard Deviation 6.38
|
17.27 pg/ml
Standard Deviation 5.29
|
|
Postprandial Serum Inflammatory Cytokines
TNFa Hour 3
|
17.14 pg/ml
Standard Deviation 5.57
|
17.87 pg/ml
Standard Deviation 5.90
|
|
Postprandial Serum Inflammatory Cytokines
TNFa Hour 4
|
17.08 pg/ml
Standard Deviation 7.21
|
17.59 pg/ml
Standard Deviation 7.82
|
|
Postprandial Serum Inflammatory Cytokines
IL-1b Hour 0
|
6.64 pg/ml
Standard Deviation 2.07
|
6.89 pg/ml
Standard Deviation 2.08
|
|
Postprandial Serum Inflammatory Cytokines
IL-1b Hour 1
|
6.76 pg/ml
Standard Deviation 1.80
|
6.69 pg/ml
Standard Deviation 2.31
|
|
Postprandial Serum Inflammatory Cytokines
IL-1b Hour 2
|
6.8 pg/ml
Standard Deviation 1.93
|
6.70 pg/ml
Standard Deviation 2.40
|
|
Postprandial Serum Inflammatory Cytokines
IL-1b Hour 3
|
6.7 pg/ml
Standard Deviation 2.35
|
6.64 pg/ml
Standard Deviation 2.25
|
|
Postprandial Serum Inflammatory Cytokines
IL-1b Hour 4
|
6.84 pg/ml
Standard Deviation 3.21
|
6.93 pg/ml
Standard Deviation 2.74
|
|
Postprandial Serum Inflammatory Cytokines
IL-6 Hour 0
|
7.55 pg/ml
Standard Deviation 9.24
|
7.69 pg/ml
Standard Deviation 11.00
|
|
Postprandial Serum Inflammatory Cytokines
IL-6 Hour 1
|
8.44 pg/ml
Standard Deviation 9.98
|
7.47 pg/ml
Standard Deviation 10.18
|
|
Postprandial Serum Inflammatory Cytokines
IL-6 Hour 3
|
8.38 pg/ml
Standard Deviation 11.76
|
8.44 pg/ml
Standard Deviation 11.47
|
|
Postprandial Serum Inflammatory Cytokines
IL-6 Hour 4
|
6.87 pg/ml
Standard Deviation 7.91
|
8.07 pg/ml
Standard Deviation 11.10
|
|
Postprandial Serum Inflammatory Cytokines
IL-10 Hour 0
|
71.55 pg/ml
Standard Deviation 45.54
|
72.67 pg/ml
Standard Deviation 54.50
|
|
Postprandial Serum Inflammatory Cytokines
IL-10 Hour 1
|
76.79 pg/ml
Standard Deviation 52.01
|
73.28 pg/ml
Standard Deviation 52.87
|
|
Postprandial Serum Inflammatory Cytokines
IL-10 Hour 2
|
79.11 pg/ml
Standard Deviation 58.30
|
72.56 pg/ml
Standard Deviation 51.45
|
|
Postprandial Serum Inflammatory Cytokines
IL-10 Hour 3
|
73.83 pg/ml
Standard Deviation 57.94
|
76.40 pg/ml
Standard Deviation 60.46
|
|
Postprandial Serum Inflammatory Cytokines
IL-10 Hour 4
|
67.50 pg/ml
Standard Deviation 58.54
|
74.45 pg/ml
Standard Deviation 59.98
|
|
Postprandial Serum Inflammatory Cytokines
IL-17 Hour 4
|
73.59 pg/ml
Standard Deviation 40.40
|
85.76 pg/ml
Standard Deviation 44.09
|
|
Postprandial Serum Inflammatory Cytokines
IL-23 Hour 0
|
957.70 pg/ml
Standard Deviation 402.55
|
1020.18 pg/ml
Standard Deviation 571.19
|
|
Postprandial Serum Inflammatory Cytokines
IL-23 Hour 1
|
989.14 pg/ml
Standard Deviation 434.31
|
1051.23 pg/ml
Standard Deviation 614.26
|
|
Postprandial Serum Inflammatory Cytokines
IL-23 Hour 2
|
1042.90 pg/ml
Standard Deviation 549.85
|
1039.69 pg/ml
Standard Deviation 473.53
|
|
Postprandial Serum Inflammatory Cytokines
IL-23 Hour 3
|
949.10 pg/ml
Standard Deviation 517.76
|
1045.52 pg/ml
Standard Deviation 547.79
|
|
Postprandial Serum Inflammatory Cytokines
IL-23 Hour 4
|
917.97 pg/ml
Standard Deviation 646.34
|
1037.87 pg/ml
Standard Deviation 658.14
|
|
Postprandial Serum Inflammatory Cytokines
INF Hour 0
|
343.49 pg/ml
Standard Deviation 232.40
|
363.51 pg/ml
Standard Deviation 258.16
|
SECONDARY outcome
Timeframe: 1 daySerum glucose concentration (mM)
Outcome measures
| Measure |
Organic Grass-fed Beef
n=10 Participants
Participants receive an organic grass-fed steak meal in the morning. After a washout period of at least 7 days, they then receive the alternative meal, conventional-fed steak meal in the morning.
Organic grass-fed beef: Participants in the organic grass-fed treatment of the study will consume a organic grass-fed steak meal for breakfast one morning.
|
Conventional-fed Beef
n=10 Participants
Participants receive a conventional-fed steak meal in the morning. After a washout period of at least 7 days, they then receive the alternative meal, an organic grass-fed steak meal in the morning.
Conventional-fed beef: Participants in the conventional-fed treatment of the study will consume a conventional-fed steak meal for breakfast one morning.
|
|---|---|---|
|
Postprandial Serum Glucose
Hour 0
|
5.52 mmol/L
Standard Deviation 0.86
|
5.41 mmol/L
Standard Deviation 0.81
|
|
Postprandial Serum Glucose
Hour 1
|
5.19 mmol/L
Standard Deviation 0.69
|
5.06 mmol/L
Standard Deviation 0.76
|
|
Postprandial Serum Glucose
Hour 2
|
5.21 mmol/L
Standard Deviation 0.63
|
5.17 mmol/L
Standard Deviation 0.72
|
|
Postprandial Serum Glucose
Hour 3
|
5.38 mmol/L
Standard Deviation 0.82
|
5.34 mmol/L
Standard Deviation 0.86
|
|
Postprandial Serum Glucose
Hour 4
|
5.44 mmol/L
Standard Deviation 0.74
|
5.37 mmol/L
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: 1 daySerum insulin concentration (microIU/mL)
Outcome measures
| Measure |
Organic Grass-fed Beef
n=10 Participants
Participants receive an organic grass-fed steak meal in the morning. After a washout period of at least 7 days, they then receive the alternative meal, conventional-fed steak meal in the morning.
Organic grass-fed beef: Participants in the organic grass-fed treatment of the study will consume a organic grass-fed steak meal for breakfast one morning.
|
Conventional-fed Beef
n=10 Participants
Participants receive a conventional-fed steak meal in the morning. After a washout period of at least 7 days, they then receive the alternative meal, an organic grass-fed steak meal in the morning.
Conventional-fed beef: Participants in the conventional-fed treatment of the study will consume a conventional-fed steak meal for breakfast one morning.
|
|---|---|---|
|
Postprandial Serum Insulin
Hour 0
|
8.99 microIU/mL
Standard Deviation 7.48
|
6.28 microIU/mL
Standard Deviation 3.92
|
|
Postprandial Serum Insulin
Hour 1
|
13.95 microIU/mL
Standard Deviation 9.20
|
15.08 microIU/mL
Standard Deviation 8.29
|
|
Postprandial Serum Insulin
Hour 2
|
12.60 microIU/mL
Standard Deviation 7.68
|
12.307 microIU/mL
Standard Deviation 8.65
|
|
Postprandial Serum Insulin
Hour 3
|
16.28 microIU/mL
Standard Deviation 29.04
|
8.95 microIU/mL
Standard Deviation 5.94
|
|
Postprandial Serum Insulin
Hour 4
|
9.97 microIU/mL
Standard Deviation 18.19
|
9.58 microIU/mL
Standard Deviation 10.10
|
Adverse Events
Organic Grass-fed Beef
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional-fed Beef
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place