An Early Phase 1 interventional study of Muscadine grape extract and Placebo in Fatigue, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-10-16.
Sponsored by Wake Forest University Health Sciences · Early Phase 1, Interventional, and Supportive care
The purpose of this research is to see if muscadine grape extract improves fatigue in people age 70 and above who have a history of treated cancer and report the symptom of fatigue.
Primary Objective: To evaluate whether administration of MGE supplementation decreases PROMIS Fatigue score from baseline to 12 weeks compared to placebo.
Secondary Objective(s)
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive muscadine grape extract orally (PO) twice daily (BID) for 12 weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO BID for 12 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up for 30 days after the last dose of the study drug.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's enrollment of 64 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Normal organ and marrow function as defined below:
Exclusion Criteria:
Muscadine grape extract pill (12 week supply)
Dietary Supplement: Muscadine grape extract · Other: Quality of Life Assessment · Other: Questionnaires · Other: Participant Feedback
Placebo provided (12 week supply)
Drug: Placebo · Other: Quality of Life Assessment · Other: Questionnaires · Other: Participant Feedback
Four pills twice daily
Four pills twice daily.
Ancillary studies
Ancillary studies
Ancillary studies
Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire
(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.
Time frame: At baseline and at 12 weeks
Pepper Assessment Tool for Disability (PAT-D) Questionnaire - Change From Baseline at 12 Weeks
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.
Time frame: At 12 weeks
Short Physical Performance Battery (SPPB)
The 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.
Time frame: At 12 weeks
Short Form Minnesota Leisure Time Activity Questionnaire (MLTA)
This 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.
Time frame: At 12 weeks
6-Minute Walk Test
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.
Time frame: At 12 weeks
Longitudinal Aging Study Amsterdam (LASA) Sedentary Behavior Questionnaire
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.
Time frame: At 12 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form (SF) - Quality of Life
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.
Time frame: At 12 weeks
Adherence - Pill Count
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.
Time frame: 12 weeks
Fried Frailty Index
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.
Time frame: At 12 weeks
| Milestone | Muscadine Grape Extract Arm | Placebo Arm |
|---|---|---|
| Started | 32 | 32 |
| Completed | 30 | 32 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
(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.
| score on a scale | Muscadine Grape Extract Arm | Placebo Arm |
|---|---|---|
| Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire | -6.6 ± 1.1 | -5.4 ± 2.2 |
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.
| mean score on a scale | Muscadine Grape Extract Arm | Placebo Arm |
|---|---|---|
| Pepper Assessment Tool for Disability (PAT-D) Questionnaire - Change From Baseline at 12 Weeks | 1.4 ± 0.1 | 1.6 ± 0.1 |
The 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.
| points | Muscadine Grape Extract Arm | Placebo Arm |
|---|---|---|
| Short Physical Performance Battery (SPPB) | 9.8 ± 0.5 | 9.2 ± 0.5 |
This 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.
| kcal/week | Muscadine Grape Extract Arm | Placebo Arm |
|---|---|---|
| Short Form Minnesota Leisure Time Activity Questionnaire (MLTA) | 3218 ± 517 | 4192 ± 1141 |
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.
| meters | Muscadine Grape Extract Arm | Placebo Arm |
|---|---|---|
| 6-Minute Walk Test | 369.8 ± 22.1 | 349.1 ± 14.4 |
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.
| hours | Muscadine Grape Extract Arm | Placebo Arm |
|---|---|---|
| Longitudinal Aging Study Amsterdam (LASA) Sedentary Behavior Questionnaire | 13.2 ± 1.0 | 12.7 ± 0.9 |
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.
| T score | Muscadine Grape Extract Arm | Placebo Arm |
|---|---|---|
| Quality of Life - Self-rate health | 3.4 ± 0.1 | 3.2 ± 0.1 |
| Quality of life - Ability to carry out social activities and roles | 3.9 ± 0.2 | 3.7 ± 0.2 |
| Physical health (t score) | 47.2 ± 1.2 | 46.3 ± 1.3 |
| Mental health (t score) | 50.6 ± 1.5 | 52.0 ± 1.3 |
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.
| number of pills | Muscadine Grape Extract Arm | Placebo Arm |
|---|---|---|
| Adherence - Pill Count | 569.1 ± 35.4 | 568.0 ± 35.8 |
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.
| score on a scale | Muscadine Grape Extract Arm | Placebo Arm |
|---|---|---|
| Fried Frailty Index | 0.9 ± 0.2 | 0.9 ± 0.2 |
Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Muscadine Grape Extract Arm | 0/32 (0%) | 0/32 (0%) | 29/32 (90.6%) |
| Placebo Arm | 0/32 (0%) | 1/32 (3.1%) | 28/32 (87.5%) |
| Event | Muscadine Grape Extract Arm | Placebo Arm |
|---|---|---|
| HyperkalemiaMetabolism and nutrition disorders | 0/32 | 1/32 |
| Event | Muscadine Grape Extract Arm | Placebo Arm |
|---|---|---|
| FlatulenceGastrointestinal disorders | 12/32 | 19/32 |
| ConstipationGastrointestinal disorders | 12/32 | 9/32 |
| DyspepsiaGastrointestinal disorders | 12/32 | 12/32 |
| NauseaGastrointestinal disorders | 4/32 | 10/32 |
| DiarrheaGastrointestinal disorders | 8/32 | 5/32 |
| Abdominal painGastrointestinal disorders | 6/32 | 6/32 |
| HyperglycemiaMetabolism and nutrition disorders | 4/32 | 5/32 |
| FatigueGeneral disorders | 4/32 | 3/32 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 4/32 | 0/32 |
| AnemiaBlood and lymphatic system disorders | 3/32 | 2/32 |
| Age, Continuous(Years) | Muscadine Grape Extract Arm | Placebo Arm | Total |
|---|---|---|---|
| Mean | 75.8 ± 5.4 | 75.8 ± 5.7 | 75.8 ± 5.5 |
| Sex: Female, Male(Participants) | Muscadine Grape Extract Arm | Placebo Arm | Total |
|---|---|---|---|
| Female | 23 | 27 | 50 |
| Male | 9 | 5 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Muscadine Grape Extract Arm | Placebo Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 30 | 30 | 60 |
| Not Hispanic or Latino | 2 | 2 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Muscadine Grape Extract Arm | Placebo Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 2 | 2 | 4 |
| White | 30 | 28 | 58 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Muscadine Grape Extract Arm | Placebo Arm | Total |
|---|---|---|---|
| United States | 32 | 32 | 64 |
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Wake Forest University Health Sciences