Trial Outcomes & Findings for Dairy Fat as a Mediator of Vitamin E Adequacy in Individuals With Metabolic Syndrome (NCT NCT01787591)
NCT ID: NCT01787591
Last Updated: 2016-11-22
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal
Results posted on
2016-11-22
Participant Flow
Participant milestones
| Measure |
Acute Fat-Free Milk Ingestion First
Participants ingested fat-free milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and soy milk.
Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Low-Fat Milk Ingestion First
Participants ingested low-free milk first and then the remaining three milks in a randomized order: fat-fat milk, full-fat milk, and soy milk.
Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Full-Fat Milk Ingestion First
Participants ingested full-free milk first and then the remaining three milks in a randomized order: low-fat milk, low-fat milk, and soy milk.
Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Soy Milk Ingestion First
Participants ingested soy milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and fat-free milk.
Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.
Soy Milk: Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
|---|---|---|---|---|
|
Period 1 (Cross-over Arm 1)
STARTED
|
5
|
5
|
5
|
6
|
|
Period 1 (Cross-over Arm 1)
COMPLETED
|
5
|
5
|
5
|
5
|
|
Period 1 (Cross-over Arm 1)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Period 2 (Cross-over Arm 2)
STARTED
|
5
|
5
|
5
|
5
|
|
Period 2 (Cross-over Arm 2)
COMPLETED
|
5
|
5
|
5
|
5
|
|
Period 2 (Cross-over Arm 2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3 (Cross-over Arm 3)
STARTED
|
5
|
5
|
5
|
5
|
|
Period 3 (Cross-over Arm 3)
COMPLETED
|
5
|
5
|
5
|
5
|
|
Period 3 (Cross-over Arm 3)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4 (Cross-over Arm 4)
STARTED
|
5
|
5
|
5
|
5
|
|
Period 4 (Cross-over Arm 4)
COMPLETED
|
5
|
5
|
5
|
5
|
|
Period 4 (Cross-over Arm 4)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Acute Fat-Free Milk Ingestion First
Participants ingested fat-free milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and soy milk.
Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Low-Fat Milk Ingestion First
Participants ingested low-free milk first and then the remaining three milks in a randomized order: fat-fat milk, full-fat milk, and soy milk.
Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Full-Fat Milk Ingestion First
Participants ingested full-free milk first and then the remaining three milks in a randomized order: low-fat milk, low-fat milk, and soy milk.
Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Soy Milk Ingestion First
Participants ingested soy milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and fat-free milk.
Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.
Soy Milk: Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
|---|---|---|---|---|
|
Period 1 (Cross-over Arm 1)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dairy Fat as a Mediator of Vitamin E Adequacy in Individuals With Metabolic Syndrome
Baseline characteristics by cohort
| Measure |
Healthy Participants
n=10 Participants
As a randomized crossover study design, participants were stratified by health status (healthy versus metabolic syndrome) and received fat-free milk, low-fat milk, full-fat milk, and soy milk in a randomized order.
|
Metabolic Syndrome Participants
n=10 Participants
As a randomized crossover study design, participants were stratified by health status (healthy versus metabolic syndrome) and received fat-free milk, low-fat milk, full-fat milk, and soy milk in a randomized order.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.3 years
STANDARD_DEVIATION 4 • n=93 Participants
|
32.8 years
STANDARD_DEVIATION 5.1 • n=4 Participants
|
31.6 years
STANDARD_DEVIATION 4.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Body mass index
|
22.6 kg/m2
STANDARD_DEVIATION 2.2 • n=93 Participants
|
37.7 kg/m2
STANDARD_DEVIATION 9.4 • n=4 Participants
|
30.2 kg/m2
STANDARD_DEVIATION 10.2 • n=27 Participants
|
|
Glucose
|
89.2 mg/dL
STANDARD_DEVIATION 6.2 • n=93 Participants
|
107.6 mg/dL
STANDARD_DEVIATION 4.2 • n=4 Participants
|
98.4 mg/dL
STANDARD_DEVIATION 13.9 • n=27 Participants
|
|
Systolic Blood Pressure
|
118.8 mmHg
STANDARD_DEVIATION 9.5 • n=93 Participants
|
128.2 mmHg
STANDARD_DEVIATION 23.6 • n=4 Participants
|
123.5 mmHg
STANDARD_DEVIATION 18.1 • n=27 Participants
|
|
Diastolic Blood Pressure
|
74.0 mmHg
STANDARD_DEVIATION 7.9 • n=93 Participants
|
79.0 mmHg
STANDARD_DEVIATION 10.1 • n=4 Participants
|
76.5 mmHg
STANDARD_DEVIATION 9.2 • n=27 Participants
|
|
Waist Circumference
|
75.2 cm
STANDARD_DEVIATION 6.5 • n=93 Participants
|
116.1 cm
STANDARD_DEVIATION 23.7 • n=4 Participants
|
95.7 cm
STANDARD_DEVIATION 27.0 • n=27 Participants
|
|
Triglyceride
|
82.0 mg/dL
STANDARD_DEVIATION 30.4 • n=93 Participants
|
152.7 mg/dL
STANDARD_DEVIATION 68.1 • n=4 Participants
|
117.4 mg/dL
STANDARD_DEVIATION 62.8 • n=27 Participants
|
|
HDL cholesterol
|
56.0 mg/dL
STANDARD_DEVIATION 9.9 • n=93 Participants
|
41.2 mg/dL
STANDARD_DEVIATION 10.8 • n=4 Participants
|
48.6 mg/dL
STANDARD_DEVIATION 12.6 • n=27 Participants
|
|
alpha-tocopherol
|
4.54 umol/mmol lipid
STANDARD_DEVIATION 0.85 • n=93 Participants
|
3.71 umol/mmol lipid
STANDARD_DEVIATION 0.85 • n=4 Participants
|
4.13 umol/mmol lipid
STANDARD_DEVIATION 0.93 • n=27 Participants
|
PRIMARY outcome
Timeframe: 0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test mealOutcome measures
| Measure |
Acute Fat-Free Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Low-Fat Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Full-Fat Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Soy Milk Ingestion
n=20 Participants
Participants received 1 cup of soy milk with deuterium labeled alpha-tocopherol
|
|---|---|---|---|---|
|
Area Under the Curve 0-72 h (Deuterium Labeled Alpha-tocopherol)
Metabolic Syndrome Participants
|
86 umol/L x h
Standard Error 8
|
84 umol/L x h
Standard Error 7
|
81 umol/L x h
Standard Error 7
|
74 umol/L x h
Standard Error 11
|
|
Area Under the Curve 0-72 h (Deuterium Labeled Alpha-tocopherol)
Healthy Participants
|
103 umol/L x h
Standard Error 7
|
115 umol/L x h
Standard Error 8
|
102 umol/L x h
Standard Error 8
|
102 umol/L x h
Standard Error 5
|
PRIMARY outcome
Timeframe: 0-72 h post-mealMaximal plasma concentration of deuterium labelled alpha-tocopherol
Outcome measures
| Measure |
Acute Fat-Free Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Low-Fat Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Full-Fat Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Soy Milk Ingestion
n=20 Participants
Participants received 1 cup of soy milk with deuterium labeled alpha-tocopherol
|
|---|---|---|---|---|
|
Cmax
Healthy
|
2.67 umol/L
Standard Error 0.2
|
2.98 umol/L
Standard Error 0.18
|
2.55 umol/L
Standard Error 0.21
|
2.67 umol/L
Standard Error 0.13
|
|
Cmax
Metabolic Syndrome
|
2.14 umol/L
Standard Error 0.2
|
2.01 umol/L
Standard Error 0.19
|
1.98 umol/L
Standard Error 0.16
|
1.88 umol/L
Standard Error 0.27
|
PRIMARY outcome
Timeframe: 0-72 h post-mealTime to maximal plasma concentration of deuterium labelled alpha-tocopherol
Outcome measures
| Measure |
Acute Fat-Free Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Low-Fat Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Full-Fat Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Soy Milk Ingestion
n=20 Participants
Participants received 1 cup of soy milk with deuterium labeled alpha-tocopherol
|
|---|---|---|---|---|
|
Tmax
Metabolic Syndrome
|
12 h
Standard Error 0
|
12 h
Standard Error 0
|
12 h
Standard Error 0
|
12 h
Standard Error 0
|
|
Tmax
Healthy
|
12 h
Standard Error 0
|
12 h
Standard Error 0
|
13.2 h
Standard Error 1.2
|
12 h
Standard Error 0
|
PRIMARY outcome
Timeframe: 0-72 h post-mealRate of plasma elimination of deuterium labelled alpha-tocopherol
Outcome measures
| Measure |
Acute Fat-Free Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Low-Fat Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Full-Fat Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Soy Milk Ingestion
n=20 Participants
Participants received 1 cup of soy milk with deuterium labeled alpha-tocopherol
|
|---|---|---|---|---|
|
Elimination Rate
Healthy
|
0.022 mmol/L/h
Standard Error 0.001
|
0.024 mmol/L/h
Standard Error 0.001
|
0.023 mmol/L/h
Standard Error 0.001
|
0.023 mmol/L/h
Standard Error 0.001
|
|
Elimination Rate
Metabolic Syndrome
|
0.019 mmol/L/h
Standard Error 0.001
|
0.020 mmol/L/h
Standard Error 0.001
|
0.021 mmol/L/h
Standard Error 0.001
|
0.022 mmol/L/h
Standard Error 0.001
|
PRIMARY outcome
Timeframe: 0-72 h post-mealAbsorption of deuterium labelled alpha-tocopherol
Outcome measures
| Measure |
Acute Fat-Free Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.
Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Low-Fat Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Full-Fat Milk Ingestion
n=20 Participants
Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.
Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
|
Acute Soy Milk Ingestion
n=20 Participants
Participants received 1 cup of soy milk with deuterium labeled alpha-tocopherol
|
|---|---|---|---|---|
|
Estimated Absorption (% Dose)
Healthy
|
27.8 % dose
Standard Error 1.4
|
32.4 % dose
Standard Error 1.6
|
28.4 % dose
Standard Error 1.3
|
28.1 % dose
Standard Error 0.88
|
|
Estimated Absorption (% Dose)
Metabolic Syndrome
|
26.6 % dose
Standard Error 1.8
|
26.0 % dose
Standard Error 2.5
|
25.6 % dose
Standard Error 1.9
|
24.62 % dose
Standard Error 2.72
|
Adverse Events
Acute Fat-Free Milk Ingestion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acute Low-Fat Milk Ingestion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acute Full-Fat Milk Ingestion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acute Soy Milk Ingestion
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