Trial Outcomes & Findings for Alleviation Of Metabolic Endotoxemia In Adults With Metabolic Syndrome With Milk Fat Globule Membrane (NCT NCT03860584)
NCT ID: NCT03860584
Last Updated: 2025-11-18
Results Overview
Data are biomarker fasting concentrations
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Day 13
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
MFGM Enriched Full-fat Dairy Milk Then Soy Phospholipid/Lecithin Milk
Participants in this sequence first received Milk fat globule membrane (MFGM) enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
Soy Phospholipid/Lecithin Milk Then MFGM-enriched Full-fat Dairy Milk
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
First Intervention (2 Weeks)
STARTED
|
17
|
13
|
|
First Intervention (2 Weeks)
COMPLETED
|
16
|
12
|
|
First Intervention (2 Weeks)
NOT COMPLETED
|
1
|
1
|
|
Washout (2 Weeks)
STARTED
|
16
|
12
|
|
Washout (2 Weeks)
COMPLETED
|
16
|
12
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (2 Weeks)
STARTED
|
16
|
12
|
|
Second Intervention (2 Weeks)
COMPLETED
|
13
|
11
|
|
Second Intervention (2 Weeks)
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
MFGM Enriched Full-fat Dairy Milk Then Soy Phospholipid/Lecithin Milk
Participants in this sequence first received Milk fat globule membrane (MFGM) enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
Soy Phospholipid/Lecithin Milk Then MFGM-enriched Full-fat Dairy Milk
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
First Intervention (2 Weeks)
Lack of Efficacy
|
1
|
0
|
|
First Intervention (2 Weeks)
Lost to Follow-up
|
0
|
1
|
|
Second Intervention (2 Weeks)
Lost to Follow-up
|
3
|
0
|
|
Second Intervention (2 Weeks)
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=30 Participants
Baseline characteristics of Metabolic Syndrome (MetS) participants at screening
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=30 Participants
|
|
Body Mass Index (kg/m2)
|
31.6 kg/m^2
STANDARD_DEVIATION 5.5 • n=30 Participants
|
|
Waist circumference (cm)
|
102.1 cm
STANDARD_DEVIATION 12.1 • n=30 Participants
|
|
Systolic blood pressure (mmHg)
|
121.0 mmHg
STANDARD_DEVIATION 15.2 • n=30 Participants
|
|
Diastolic blood pressure (mmHg)
|
81.5 mmHg
STANDARD_DEVIATION 10.4 • n=30 Participants
|
|
Plasma Triglyceride (mg/dL)
|
108.6 mg/dL
STANDARD_DEVIATION 95.6 • n=30 Participants
|
|
Plasma HDL-C (mg/dL)
|
42.3 mg/dL
STANDARD_DEVIATION 13.7 • n=30 Participants
|
|
Plasma glucose (mg/dL)
|
99.7 mg/dL
STANDARD_DEVIATION 14.4 • n=30 Participants
|
PRIMARY outcome
Timeframe: Day 13Data are biomarker fasting concentrations
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Serum Endotoxin
|
30.6 EU/ml
Standard Error 2.1
|
32.5 EU/ml
Standard Error 2.3
|
PRIMARY outcome
Timeframe: Day 13 (0, 30, 60, 90, 120, 150, 180 minutes post-meal challenge)Data are biomarker area under the time-concentration curve (0-3 hours) on day 13
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Serum Endotoxin
|
3972.6 EU/ml x min
Standard Error 470.8
|
3855.4 EU/ml x min
Standard Error 498.1
|
SECONDARY outcome
Timeframe: Day 13 (0, 30, 60, 90, 120, 150, 180 minutes post-meal challenge)Data are biomarker area under the time-concentration curve (0-3 hours) on day 13
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Plasma Glucose
|
2124.1 mg/dL x min
Standard Error 723.8
|
5453.6 mg/dL x min
Standard Error 479.9
|
SECONDARY outcome
Timeframe: Day 13Data are biomarker fasting concentrations
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Plasma Glucose
|
99.6 mg/dL
Standard Error 2.5
|
98.1 mg/dL
Standard Error 1.6
|
SECONDARY outcome
Timeframe: Day 13Data are biomarker fasting concentrations
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Plasma Insulin
|
14.5 uIU/mL
Standard Error 6.0
|
15.1 uIU/mL
Standard Error 6.5
|
SECONDARY outcome
Timeframe: day 13 (0, 30, 60, 90, 120, 150, 180 minutes post-meal challenge)Data are biomarker area under the time-concentration curve (0-3 hours) on day 13
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Plasma Insulin
|
13678.3 uIU/mL x min
Standard Error 1766.0
|
16253.2 uIU/mL x min
Standard Error 2017.0
|
SECONDARY outcome
Timeframe: Day 13Data are biomarker fasting concentrations
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Plasma HDL-C
|
34.1 mg/dL
Standard Error 1.4
|
32.3 mg/dL
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Day 13Data are biomarker fasting concentrations
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Plasma Triglyceride
|
103.3 mg/dL
Standard Error 9.9
|
101.7 mg/dL
Standard Error 8.0
|
SECONDARY outcome
Timeframe: Day 13Data are biomarker fasting concentrations
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Plasma Total Cholesterol
|
161.8 mg/dL
Standard Error 8.3
|
187.0 mg/dL
Standard Error 8.9
|
SECONDARY outcome
Timeframe: Day 13Data are biomarker fasting concentrations
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Plasma Glucagon-like Peptide-1
|
6.7 pmol/L
Standard Error 2.2
|
6.0 pmol/L
Standard Error 1.6
|
SECONDARY outcome
Timeframe: Day 13Data are the 24-hour urinary excretion ratio of lactulose relative to mannitol post-meal challenge on day 13
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Urine Lactulose/Mannitol
|
0.0777 ratio
Standard Error 0.0069
|
0.0854 ratio
Standard Error 0.0084
|
SECONDARY outcome
Timeframe: 5-24 hoursData are the 24-hour urinary excretion ratio of sucralose relative to erythritol post-meal challenge on day 13
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Urine Sucralose/Erythritol
|
0.0172 ratio
Standard Error 0.0014
|
0.0174 ratio
Standard Error 0.0017
|
SECONDARY outcome
Timeframe: Day 13Data are biomarker fecal concentrations
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Fecal Acetate
|
42.1 umol/g
Standard Error 3.9
|
39.7 umol/g
Standard Error 3.5
|
SECONDARY outcome
Timeframe: Day 13Data are biomarker fecal concentrations
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Fecal Butyrate
|
19.96 umol/g
Standard Error 2.23
|
16.51 umol/g
Standard Error 1.81
|
SECONDARY outcome
Timeframe: Day 13Data are biomarker fecal concentrations
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Fecal Propionate
|
23.73 umol/g
Standard Error 2.71
|
21.38 umol/g
Standard Error 1.92
|
SECONDARY outcome
Timeframe: Day 13Data are biomarker fasting concentrations
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Plasma Gastric Inhibitory Polypeptide
|
90.6 pg/mL
Standard Error 13.2
|
67.0 pg/mL
Standard Error 6.9
|
SECONDARY outcome
Timeframe: Day 13Data are biomarker fecal concentrations
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Fecal Calprotectin
|
53.0 ug/g
Standard Error 13.3
|
47.8 ug/g
Standard Error 10.4
|
SECONDARY outcome
Timeframe: Day 13Data are biomarker fecal concentrations
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Fecal Myeloperoxidase
|
163.6 ng/g
Standard Error 20.4
|
166.7 ng/g
Standard Error 18.4
|
SECONDARY outcome
Timeframe: Day 13Data are expression levels of whole blood target gene normalized to housekeeping gene (β-actin) expression levels.
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Whole-blood Messenger RNA Expression of Toll-like Receptor-4 at Fasting
|
.91 log2(fold change)
Standard Error .07
|
.087 log2(fold change)
Standard Error .06
|
SECONDARY outcome
Timeframe: Day 13Data are expression levels of whole blood target gene normalized to housekeeping gene (β-actin) expression levels.
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Whole-blood Messenger RNA Expression of Interleukin-6 at Fasting
|
0.71 log2(fold change)
Standard Error .15
|
0.81 log2(fold change)
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Day 13Data are expression levels of whole blood target gene normalized to housekeeping gene (β-actin) expression levels.
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Whole Blood Messenger RNA Expression of Tumor Necrosis Factor-alpha at Fasting
|
0.83 log2(fold change)
Standard Error 0.12
|
0.91 log2(fold change)
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Day 13, 3 h post-mealData are expression levels of whole blood target gene normalized to housekeeping gene (β-actin) expression levels measure at 3-hours post-meal challenge
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Whole Blood Messenger RNA Expression of Toll-like Receptor-4 at 3 h Post-meal Challenge
|
0.93 log2(fold change)
Standard Error 0.07
|
0.89 log2(fold change)
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Day 13, 3 h post-mealData are expression levels of whole blood target gene normalized to housekeeping gene (β-actin) expression levels measure at 3-hours post-meal challenge
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Whole Blood Messenger RNA Expression of Interleukin-6 at 3 h Post-meal Challenge
|
0.85 log2(fold change)
Standard Error 0.14
|
0.91 log2(fold change)
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Day 13, 3 h post-mealData are expression levels of whole blood target gene normalized to housekeeping gene (β-actin) expression levels measure at 3-hours post-meal challenge
Outcome measures
| Measure |
Soy Phospholipid/Lecithin Milk
n=24 Participants
Participants in this sequence first received soy phospholipid/lecithin milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks).
|
MFGM-enriched Full-fat Dairy Milk
n=24 Participants
Participants in this sequence first received MFGM-enriched full-fat dairy milk (3 servings/day for 2 weeks), followed by a 2-week washout, and then soy phospholipid/lecithin milk (3 servings/day for 2 weeks).
|
|---|---|---|
|
Whole Blood Messenger RNA Expression of Tumor Necrosis Factor-alpha at 3 h Post-meal Challenge
|
0.97 log2(fold change)
Standard Error 0.11
|
0.75 log2(fold change)
Standard Error 0.07
|
Adverse Events
MFGM-enriched Full-fat Dairy Milk
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Soy Phospholipid/Lecithin Milk
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