Trial Outcomes & Findings for Evaluation of Diet and Sleep in Vascular Health: A Pilot Study (NCT NCT04990973)
NCT ID: NCT04990973
Last Updated: 2024-10-17
Results Overview
The 19 questions which compose this survey assess sleep quality, latency, duration, habitual sleep efficiency, sleep disturbances, medication use and daytime dysfunction. Scores range 0 (minimum) to 21 (maximum) with \>5 indicating poor sleep quality so a lower score is a better outcome.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
4 weeks
Results posted on
2024-10-17
Participant Flow
11 individuals signed a consent form prior to screening assessments. Of those, 4 participants passed the eligibility criteria and were randomized to a study condition and participated in the study activities.
Participant milestones
| Measure |
Mediterranean Diet, Then Average American Diet
Healthy participants that are randomized to the MedDiet followed by a 4-week washout and a crossover to the AAD.
Average American Diet (AAD): Participants will follow specified diet requirements.
Macronutrient targets for the AAD will be approximately 35-37% of energy from fat (13.5% from saturated fat), 15% from protein, and 48-50% from carbohydrates (10 g fiber/d for an average 2000 kcal/d diet).
Mediterranean Diet: Participants will follow specified diet requirements. Macronutrient targets for the Mediterranean diet will be approximately 40% of energy from fat (8.5% from saturated fat), 20% of energy from protein, and 40% from carbohydrates (40 g fiber/d for an average 2000 kcal/d diet).
|
Average American Diet, Then Mediterranean Diet
Healthy participants that are randomized to AAD followed by a 4-week washout and a crossover to the Mediterranean Diet.
Average American Diet (AAD): Participants will follow specified diet requirements.
Macronutrient targets for the AAD will be approximately 35-37% of energy from fat (13.5% from saturated fat), 15% from protein, and 48-50% from carbohydrates (10 g fiber/d for an average 2000 kcal/d diet).
Mediterranean Diet: Participants will follow specified diet requirements. Macronutrient targets for the Mediterranean diet will be approximately 40% of energy from fat (8.5% from saturated fat), 20% of energy from protein, and 40% from carbohydrates (40 g fiber/d for an average 2000 kcal/d diet).
|
|---|---|---|
|
First Intervention (4 Weeks)
STARTED
|
2
|
2
|
|
First Intervention (4 Weeks)
COMPLETED
|
2
|
2
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Washout (4 Weeks)
STARTED
|
2
|
2
|
|
Washout (4 Weeks)
COMPLETED
|
2
|
2
|
|
Washout (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (4 Weeks)
STARTED
|
2
|
2
|
|
Second Intervention (4 Weeks)
COMPLETED
|
2
|
2
|
|
Second Intervention (4 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Diet and Sleep in Vascular Health: A Pilot Study
Baseline characteristics by cohort
| Measure |
Mediterranean Diet and Then AAD
n=2 Participants
Healthy participants that are randomized to the MedDiet followed by a 4-week washout and a crossover to the AAD.
Average American Diet (AAD): Participants will follow specified diet requirements.
Macronutrient targets for the AAD will be approximately 35-37% of energy from fat (13.5% from saturated fat), 15% from protein, and 48-50% from carbohydrates (10 g fiber/d for an average 2000 kcal/d diet).
Mediterranean Diet: Participants will follow specified diet requirements.
Macronutrient targets for the Mediterranean diet will be approximately 40% of energy from fat (8.5% from saturated fat), 20% of energy from protein, and 40% from carbohydrates (40 g fiber/d for an average 2000 kcal/d diet).
|
Average American Diet (AAD) and Then Mediterranean Diet
n=2 Participants
Healthy participants that are randomized to AAD followed by a 4-week washout and a crossover to the Mediterranean Diet.
Average American Diet (AAD): Participants will follow specified diet requirements.
Macronutrient targets for the AAD will be approximately 35-37% of energy from fat (13.5% from saturated fat), 15% from protein, and 48-50% from carbohydrates (10 g fiber/d for an average 2000 kcal/d diet).
Mediterranean Diet: Participants will follow specified diet requirements.
Macronutrient targets for the Mediterranean diet will be approximately 40% of energy from fat (8.5% from saturated fat), 20% of energy from protein, and 40% from carbohydrates (40 g fiber/d for an average 2000 kcal/d diet).
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
34.8 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
PSQI
|
3.5 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
5 units on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Sleep Fragmentation Index
|
29.9 percent
STANDARD_DEVIATION 8.9 • n=5 Participants
|
15.9 percent
STANDARD_DEVIATION 5.5 • n=7 Participants
|
22.9 percent
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sleep duration
|
386.6 minutes per night
STANDARD_DEVIATION 17.0 • n=5 Participants
|
402.4 minutes per night
STANDARD_DEVIATION 26.2 • n=7 Participants
|
394.5 minutes per night
STANDARD_DEVIATION 20.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 1 participant in the Mediterranean Diet condition did not complete the questionnaire.
The 19 questions which compose this survey assess sleep quality, latency, duration, habitual sleep efficiency, sleep disturbances, medication use and daytime dysfunction. Scores range 0 (minimum) to 21 (maximum) with \>5 indicating poor sleep quality so a lower score is a better outcome.
Outcome measures
| Measure |
Mediterranean Diet Condition
n=3 Participants
Mediterranean Diet: Participants will follow specified diet requirements.
Macronutrient targets for the Mediterranean diet will be approximately 40% of energy from fat (8.5% from saturated fat), 20% of energy from protein, and 40% from carbohydrates (40 g fiber/d for an average 2000 kcal/d diet).
|
Average American Diet (AAD) Condition
n=4 Participants
Average American Diet (AAD): Participants will follow specified diet requirements.
Macronutrient targets for the AAD will be approximately 35-37% of energy from fat (13.5% from saturated fat), 15% from protein, and 48-50% from carbohydrates (10 g fiber/d for an average 2000 kcal/d diet).
|
|---|---|---|
|
Score on the Pittsburgh Sleep Quality Index (PSQI)
|
0.3 units on a scale
Standard Deviation 1.5
|
-0.5 units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: 4 weeksSleep Fragmentation is an index of restlessness during the sleep period expressed as a percentage (0 to 100%). The higher the index, the more sleep is disrupted.
Outcome measures
| Measure |
Mediterranean Diet Condition
n=4 Participants
Mediterranean Diet: Participants will follow specified diet requirements.
Macronutrient targets for the Mediterranean diet will be approximately 40% of energy from fat (8.5% from saturated fat), 20% of energy from protein, and 40% from carbohydrates (40 g fiber/d for an average 2000 kcal/d diet).
|
Average American Diet (AAD) Condition
n=4 Participants
Average American Diet (AAD): Participants will follow specified diet requirements.
Macronutrient targets for the AAD will be approximately 35-37% of energy from fat (13.5% from saturated fat), 15% from protein, and 48-50% from carbohydrates (10 g fiber/d for an average 2000 kcal/d diet).
|
|---|---|---|
|
Sleep Fragmentation Index
|
11.0 percent
Standard Deviation 2.8
|
15.8 percent
Standard Deviation 8.4
|
PRIMARY outcome
Timeframe: 4 weeksSleep duration will be actigraphy-derived.
Outcome measures
| Measure |
Mediterranean Diet Condition
n=4 Participants
Mediterranean Diet: Participants will follow specified diet requirements.
Macronutrient targets for the Mediterranean diet will be approximately 40% of energy from fat (8.5% from saturated fat), 20% of energy from protein, and 40% from carbohydrates (40 g fiber/d for an average 2000 kcal/d diet).
|
Average American Diet (AAD) Condition
n=4 Participants
Average American Diet (AAD): Participants will follow specified diet requirements.
Macronutrient targets for the AAD will be approximately 35-37% of energy from fat (13.5% from saturated fat), 15% from protein, and 48-50% from carbohydrates (10 g fiber/d for an average 2000 kcal/d diet).
|
|---|---|---|
|
Average Sleep Duration Per Night
|
403.7 minutes per night
Standard Deviation 52.0
|
424.0 minutes per night
Standard Deviation 51.3
|
SECONDARY outcome
Timeframe: Change from baseline to 4 weeksPopulation: Due to study termination, data was not collected and therefore not analyzed.
Urinary 6-sulfatoxymelatonin will be measured by competitive ELISA and urine creatinine by clinical chemistry analyzer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 4 weeksPopulation: Due to study termination, data was not collected and therefore not analyzed.
Tryptophan metabolism
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 4 weeksPopulation: Due to study termination, data was not collected and therefore not analyzed.
Tryptophan metabolism
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 4 weeksPopulation: Due to study termination, data was not collected and therefore not analyzed.
Neurotransmitter
Outcome measures
Outcome data not reported
Adverse Events
Mediterranean Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Average American Diet (AAD)
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
Dr. Marie-Pierre St-Onge
Columbia University Irving Medical Center
Phone: 212-305-9379
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place