Trial Outcomes & Findings for Muscadine Grape Extract to Improve Fatigue (NCT NCT04495751)
NCT ID: NCT04495751
Last Updated: 2025-10-16
Results Overview
(PROMIS) Fatigue 7a will be used to assess fatigue. Using a mixed effects model with a constraint of a common baseline mean across treatment groups and an unstructured covariance matrix to model all fatigue measures over time, and use linear contrasts to estimate the difference in change and corresponding 90% confidence interval between the two groups. Item responses are rated on a five-point scale ranging from "never" to "always" and are summed for a total score and transformed to a T-score metric, which has a mean of 50 and a standard deviation of 10. Higher scores indicate more fatigue.
COMPLETED
EARLY_PHASE1
64 participants
At baseline and at 12 weeks
2025-10-16
Participant Flow
Participant milestones
| Measure |
Muscadine Grape Extract Arm
Muscadine grape extract pill (12 week supply)
Muscadine grape extract: Four pills twice daily
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Placebo Arm
Placebo provided (12 week supply)
Placebo: Four pills twice daily.
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
30
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Muscadine Grape Extract Arm
Muscadine grape extract pill (12 week supply)
Muscadine grape extract: Four pills twice daily
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Placebo Arm
Placebo provided (12 week supply)
Placebo: Four pills twice daily.
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Muscadine Grape Extract to Improve Fatigue
Baseline characteristics by cohort
| Measure |
Muscadine Grape Extract Arm
n=32 Participants
Muscadine grape extract pill (12 week supply)
Muscadine grape extract: Four pills twice daily
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Placebo Arm
n=32 Participants
Placebo provided (12 week supply)
Placebo: Four pills twice daily.
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.8 Years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
75.8 Years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
75.8 Years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 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
|
32 participants
n=5 Participants
|
32 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline and at 12 weeksPopulation: Not all participants reported data for this outcome measure.
(PROMIS) Fatigue 7a will be used to assess fatigue. Using a mixed effects model with a constraint of a common baseline mean across treatment groups and an unstructured covariance matrix to model all fatigue measures over time, and use linear contrasts to estimate the difference in change and corresponding 90% confidence interval between the two groups. Item responses are rated on a five-point scale ranging from "never" to "always" and are summed for a total score and transformed to a T-score metric, which has a mean of 50 and a standard deviation of 10. Higher scores indicate more fatigue.
Outcome measures
| Measure |
Muscadine Grape Extract Arm
n=30 Participants
Muscadine grape extract pill (12 week supply)
Muscadine grape extract: Four pills twice daily
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Placebo Arm
n=32 Participants
Placebo provided (12 week supply)
Placebo: Four pills twice daily.
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
|---|---|---|
|
Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire
|
-6.6 score on a scale
Standard Error 1.1
|
-5.4 score on a scale
Standard Error 2.2
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: Not all participants reported data for this outcome measure.
Pepper Assessment Tool for Disability (PAT-D) will used to assess self-reported physical function. The (PAT-D) is a 19-item survey designed to assess domains of physical function in older adults which contains subscales on mobility, instrumental activities of daily living (IADLs), and basic activities of daily living (ADLs). Participant responses will best describe their ability to perform certain activities of daily living (On a scale of 1 to 5; 1 = usually did with no difficulty to 5 = unable to do. Minimum score of 19, max score of 95. A lower score indicates less difficulty with tasks and better function. Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks reported as mean and standard error scores.
Outcome measures
| Measure |
Muscadine Grape Extract Arm
n=29 Participants
Muscadine grape extract pill (12 week supply)
Muscadine grape extract: Four pills twice daily
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Placebo Arm
n=30 Participants
Placebo provided (12 week supply)
Placebo: Four pills twice daily.
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
|---|---|---|
|
Pepper Assessment Tool for Disability (PAT-D) Questionnaire - Change From Baseline at 12 Weeks
|
1.4 mean score on a scale
Standard Error 0.1
|
1.6 mean score on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: At 12 weeksThe Short Physical Performance Battery (SPPB) will be used to objectively assess lower extremity physical function. This validated measure comprises a short walk, repeated chair stands, and balance test. Each section is scored out of 4 points, so the highest total score for the SPPB is 12 points. Score range is 0-12. Poor (0-6), moderate 7-9) and good (10-12). Lower scores on the SPPB have been associated with increased risk of disability, hospitalization and worse survival among older adults with and without cancer. Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks.
Outcome measures
| Measure |
Muscadine Grape Extract Arm
n=30 Participants
Muscadine grape extract pill (12 week supply)
Muscadine grape extract: Four pills twice daily
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Placebo Arm
n=32 Participants
Placebo provided (12 week supply)
Placebo: Four pills twice daily.
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
|---|---|---|
|
Short Physical Performance Battery (SPPB)
|
9.8 points
Standard Error 0.5
|
9.2 points
Standard Error 0.5
|
SECONDARY outcome
Timeframe: At 12 weeksThis questionnaire will assess self-reported physical activity with participants answering yes/no questions in regards to physical activities done in the past two weeks and the frequency of those activities. Score is interpreted by calculating the total energy expenditure based on the frequency and duration of reported leisure activities, with higher scores indicating a greater level of physical activity; generally, scores are categorized as low (inactive), moderate (moderately active), and high (highly active). Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks.
Outcome measures
| Measure |
Muscadine Grape Extract Arm
n=30 Participants
Muscadine grape extract pill (12 week supply)
Muscadine grape extract: Four pills twice daily
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Placebo Arm
n=32 Participants
Placebo provided (12 week supply)
Placebo: Four pills twice daily.
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
|---|---|---|
|
Short Form Minnesota Leisure Time Activity Questionnaire (MLTA)
|
3218 kcal/week
Standard Error 517
|
4192 kcal/week
Standard Error 1141
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: Not all participants reported data for this outcome measure.
A 6-minute walk will be measured to assess physical fitness. The 6-minute walk is easy to administer in a clinical setting, accurately assesses submaximal exercise capacity, is an independent predictor of mortality and is correlated with peak V02 testing. The number of laps and distance walked on the final lap will be recorded. The total distance the participant walked will be entered onto the online database (1 lap = 30 meters distance). Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks.
Outcome measures
| Measure |
Muscadine Grape Extract Arm
n=29 Participants
Muscadine grape extract pill (12 week supply)
Muscadine grape extract: Four pills twice daily
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Placebo Arm
n=29 Participants
Placebo provided (12 week supply)
Placebo: Four pills twice daily.
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
|---|---|---|
|
6-Minute Walk Test
|
369.8 meters
Standard Error 22.1
|
349.1 meters
Standard Error 14.4
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: Not all participants reported data for this outcome measure.
The questionnaire will be used to measure sedentary behavior for time spent during a 24 hour period for weekday and weekend various activities. The questionnaire consists of 10 items. The average time per 24 hours on each sedentary activity will be recorded in hours and/or minutes. Scores represent the self-reported average time an older adult spends engaged in sedentary activities (i.e., watching TV, reading, or sitting during a typical weekday and weekend day), with higher scores indicating a greater amount of time spent sedentary. Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks.
Outcome measures
| Measure |
Muscadine Grape Extract Arm
n=30 Participants
Muscadine grape extract pill (12 week supply)
Muscadine grape extract: Four pills twice daily
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Placebo Arm
n=32 Participants
Placebo provided (12 week supply)
Placebo: Four pills twice daily.
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
|---|---|---|
|
Longitudinal Aging Study Amsterdam (LASA) Sedentary Behavior Questionnaire
|
13.2 hours
Standard Error 1.0
|
12.7 hours
Standard Error 0.9
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: Not all participants reported data for this outcome measure.
The PROMIS Global Health Short Form (SF) is a 10-item questionnaire that will assess global quality of life including overall physical health, mental health, social health, pain, fatigue an overall perceived quality of life. Participants will respond to questions or statements with varied selections (excellent to poor; completely to not at all; never to always; and none to very severe). Scores above 50 are considered a better than average quality of life and scores below 50 are considered below average quality of life. Higher T-scores indicate better health, so scores around 50 are average, while scores below 40 suggest poor health warranting further assessment, and scores above 60 indicate excellent health. 50 indicates the population mean with a standard deviation of 10 Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks.
Outcome measures
| Measure |
Muscadine Grape Extract Arm
n=30 Participants
Muscadine grape extract pill (12 week supply)
Muscadine grape extract: Four pills twice daily
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Placebo Arm
n=32 Participants
Placebo provided (12 week supply)
Placebo: Four pills twice daily.
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form (SF) - Quality of Life
Quality of Life - Self-rate health
|
3.4 T score
Standard Error 0.1
|
3.2 T score
Standard Error 0.1
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form (SF) - Quality of Life
Quality of life - Ability to carry out social activities and roles
|
3.9 T score
Standard Error 0.2
|
3.7 T score
Standard Error 0.2
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form (SF) - Quality of Life
Physical health (t score)
|
47.2 T score
Standard Error 1.2
|
46.3 T score
Standard Error 1.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form (SF) - Quality of Life
Mental health (t score)
|
50.6 T score
Standard Error 1.5
|
52.0 T score
Standard Error 1.3
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Not all participants reported data for this outcome measure.
Adherence will be measured by pill count at study completion. Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks.
Outcome measures
| Measure |
Muscadine Grape Extract Arm
n=30 Participants
Muscadine grape extract pill (12 week supply)
Muscadine grape extract: Four pills twice daily
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Placebo Arm
n=30 Participants
Placebo provided (12 week supply)
Placebo: Four pills twice daily.
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
|---|---|---|
|
Adherence - Pill Count
|
569.1 number of pills
Standard Error 35.4
|
568.0 number of pills
Standard Error 35.8
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: Not all participants reported data for this outcome measure.
Frailty indexes will be assessed for differences between the two arms. The Fried frailty index is a scoring system that classifies people into three stages of frailty based on five criteria: weight loss, exhaustion, low physical activity, and slowness. Frailty index scores can be calculated by dividing the sum of the recoded values of the variables by the number of variables measured for a person. Corresponding scores are: Score of 0, non-frail; score of 1-2 pre-frail; score of 3-5 frail. Higher scores represent higher rates of frailty among participants. Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks.
Outcome measures
| Measure |
Muscadine Grape Extract Arm
n=30 Participants
Muscadine grape extract pill (12 week supply)
Muscadine grape extract: Four pills twice daily
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Placebo Arm
n=31 Participants
Placebo provided (12 week supply)
Placebo: Four pills twice daily.
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
|---|---|---|
|
Fried Frailty Index
|
0.9 score on a scale
Standard Error 0.2
|
0.9 score on a scale
Standard Error 0.2
|
Adverse Events
Muscadine Grape Extract Arm
Placebo Arm
Serious adverse events
| Measure |
Muscadine Grape Extract Arm
n=32 participants at risk
Muscadine grape extract pill (12 week supply)
Muscadine grape extract: Four pills twice daily
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Placebo Arm
n=32 participants at risk
Placebo provided (12 week supply)
Placebo: Four pills twice daily.
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/32 • 12 weeks
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
Muscadine Grape Extract Arm
n=32 participants at risk
Muscadine grape extract pill (12 week supply)
Muscadine grape extract: Four pills twice daily
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
Placebo Arm
n=32 participants at risk
Placebo provided (12 week supply)
Placebo: Four pills twice daily.
Quality of Life Assessment: Ancillary studies
Questionnaires: Ancillary studies
Participant Feedback: Ancillary studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
9.4%
3/32 • Number of events 3 • 12 weeks
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
6/32 • Number of events 6 • 12 weeks
|
18.8%
6/32 • Number of events 7 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
37.5%
12/32 • Number of events 13 • 12 weeks
|
28.1%
9/32 • Number of events 12 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
8/32 • Number of events 9 • 12 weeks
|
15.6%
5/32 • Number of events 7 • 12 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
37.5%
12/32 • Number of events 14 • 12 weeks
|
37.5%
12/32 • Number of events 15 • 12 weeks
|
|
Gastrointestinal disorders
Flatulence
|
37.5%
12/32 • Number of events 13 • 12 weeks
|
59.4%
19/32 • Number of events 22 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
12.5%
4/32 • Number of events 5 • 12 weeks
|
31.2%
10/32 • Number of events 11 • 12 weeks
|
|
General disorders
Fatigue
|
12.5%
4/32 • Number of events 5 • 12 weeks
|
9.4%
3/32 • Number of events 4 • 12 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/32 • 12 weeks
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
4/32 • Number of events 4 • 12 weeks
|
15.6%
5/32 • Number of events 6 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
3/32 • Number of events 3 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
9.4%
3/32 • Number of events 3 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/32 • 12 weeks
|
9.4%
3/32 • Number of events 3 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
4/32 • Number of events 5 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/32 • 12 weeks
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
0.00%
0/32 • 12 weeks
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/32 • 12 weeks
|
9.4%
3/32 • Number of events 3 • 12 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
9.4%
3/32 • Number of events 3 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
|
Investigations
Platelet count decreased
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
|
Psychiatric disorders
Insomnia
|
6.2%
2/32 • Number of events 2 • 12 weeks
|
0.00%
0/32 • 12 weeks
|
Additional Information
Principal Investigator
Wake Forest Baptist Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place