Trial Outcomes & Findings for Effect of a Dietary Supplement on Quality of Life (NCT NCT05323084)
NCT ID: NCT05323084
Last Updated: 2024-12-16
Results Overview
Total score ranges from 20 to 140 with higher scores being better quality of life
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
1 week
Results posted on
2024-12-16
Participant Flow
Participant milestones
| Measure |
Dietary Supplement First and Placebo Second
Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
Placebo First Dietary Supplement Second
60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
|---|---|---|
|
Period 1
STARTED
|
5
|
5
|
|
Period 1
COMPLETED
|
5
|
5
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2 - Washout
STARTED
|
5
|
5
|
|
Period 2 - Washout
COMPLETED
|
5
|
4
|
|
Period 2 - Washout
NOT COMPLETED
|
0
|
1
|
|
Period 3
STARTED
|
5
|
4
|
|
Period 3
COMPLETED
|
5
|
4
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dietary Supplement First and Placebo Second
Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
Placebo First Dietary Supplement Second
60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
|---|---|---|
|
Period 2 - Washout
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Effect of a Dietary Supplement on Quality of Life
Baseline characteristics by cohort
| Measure |
Baseline Characteristic of Study Participant
n=10 Participants
Characteristics of the study participant prior to any intervention
|
|---|---|
|
Age, Continuous
|
59 Years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Body mass index
|
30 kg per meter square
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Glucose
|
98 mg/dL
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Wake after sleep onset
|
75 minutes
STANDARD_DEVIATION 33 • n=5 Participants
|
|
Insomnia severtiy index
|
21 scores on a scale.
STANDARD_DEVIATION 4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekTotal score ranges from 20 to 140 with higher scores being better quality of life
Outcome measures
| Measure |
Dietary Supplement
n=9 Participants
Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
Placebo
n=10 Participants
60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
|---|---|---|
|
Chubon Lifestyle Score
Baseline
|
103.9 score on a scale
Standard Error 2.5
|
100.9 score on a scale
Standard Error 2.4
|
|
Chubon Lifestyle Score
Follow up
|
100.4 score on a scale
Standard Error 2.5
|
102.9 score on a scale
Standard Error 2.4
|
SECONDARY outcome
Timeframe: 1 weekTotal Score ranges from 0 to 21 with higher sleep quality having lower numerical values
Outcome measures
| Measure |
Dietary Supplement
n=9 Participants
Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
Placebo
n=10 Participants
60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
|---|---|---|
|
Pittsburgh Sleep Quality Index Score
Baseline
|
10.8 score on a scale
Standard Error 1
|
10.5 score on a scale
Standard Error 1.0
|
|
Pittsburgh Sleep Quality Index Score
Follow-up
|
9.1 score on a scale
Standard Error 1
|
8.3 score on a scale
Standard Error 1
|
SECONDARY outcome
Timeframe: 1 weekTotal Score score 0-24 with higher scores having greater degree of sleepiness
Outcome measures
| Measure |
Dietary Supplement
n=9 Participants
Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
Placebo
n=10 Participants
60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
|---|---|---|
|
Epworth Sleepiness Scale
Baseline
|
8.4 score on a scale
Standard Error 1.2
|
8.8 score on a scale
Standard Error 1.2
|
|
Epworth Sleepiness Scale
Follow up
|
9.9 score on a scale
Standard Error 1.2
|
6.9 score on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: 1-weekIndex of self-perceived general fatigue. Score range from 4 to 20 with high score indicative of more fatigue.
Outcome measures
| Measure |
Dietary Supplement
n=9 Participants
Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
Placebo
n=10 Participants
60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
|---|---|---|
|
Multidimensional Fatigue Index -General Fatigue
Baseline
|
15.1 score on a scale
Standard Error 1.0
|
14.7 score on a scale
Standard Error 1.0
|
|
Multidimensional Fatigue Index -General Fatigue
Follow-up
|
14.0 score on a scale
Standard Error 1.0
|
13.4 score on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: 1 weekIndex of self-perceived physical fatigue. Score range of 4 to 20 with higher score indicative more fatigue.
Outcome measures
| Measure |
Dietary Supplement
n=9 Participants
Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
Placebo
n=10 Participants
60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
|---|---|---|
|
Multidimensional Fatigue Index - Physical Fatigue
Baseline
|
11.1 score on a scale
Standard Error 1.3
|
10.3 score on a scale
Standard Error 1.3
|
|
Multidimensional Fatigue Index - Physical Fatigue
Follow up
|
9.5 score on a scale
Standard Error 1.3
|
11.3 score on a scale
Standard Error 1.3
|
SECONDARY outcome
Timeframe: 1 weekIndex of self-perceived mental fatigue. Score ranges from 4 to 20 with higher scores indicative of more fatigue.
Outcome measures
| Measure |
Dietary Supplement
n=9 Participants
Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
Placebo
n=10 Participants
60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
|---|---|---|
|
Multidimensional Fatigue Index - Mental Fatigue
Baseline
|
11.7 score on a scale
Standard Error 1
|
12.5 score on a scale
Standard Error 1
|
|
Multidimensional Fatigue Index - Mental Fatigue
Follow-up
|
12.4 score on a scale
Standard Error 1
|
11.7 score on a scale
Standard Error 1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-weekDetermined by Polysomnography - time it takes for a person to fall asleep in min
Outcome measures
| Measure |
Dietary Supplement
n=9 Participants
Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
Placebo
n=10 Participants
60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
|---|---|---|
|
Sleep Latency
Baseline
|
28 Minutes
Standard Error 8
|
32 Minutes
Standard Error 8
|
|
Sleep Latency
Follow-up
|
24 Minutes
Standard Error 8
|
28 Minutes
Standard Error 8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-weekDetermined by polysomnography - total number of minutes a person is awake after having initially fallen asleep in min.
Outcome measures
| Measure |
Dietary Supplement
n=9 Participants
Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
Placebo
n=10 Participants
60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
|---|---|---|
|
Wake After Sleep Onset
Baseline
|
77 Minutes
Standard Error 21
|
71 Minutes
Standard Error 20
|
|
Wake After Sleep Onset
Follow-up
|
79 Minutes
Standard Error 21
|
72 Minutes
Standard Error 20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-weekDetermined by polysomnography - ratio of the total time spent asleep in a night compared to the total time spent in bed in percentage.
Outcome measures
| Measure |
Dietary Supplement
n=9 Participants
Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
Placebo
n=10 Participants
60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions
|
|---|---|---|
|
Sleep Efficiency
Baseline
|
80 % of total sleep time
Standard Error 4
|
80 % of total sleep time
Standard Error 4
|
|
Sleep Efficiency
Follow-up
|
80 % of total sleep time
Standard Error 4
|
81 % of total sleep time
Standard Error 4
|
Adverse Events
Dietary Supplement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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