Back to results

Papaya Study ID:20140628

Primary Purpose

Systemic Inflammation, Aging

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Fermented Papaya Preparation (FPP)

Sugar Pill

About this trial

This is an interventional basic science trial for Systemic Inflammation focused on measuring Aging, Papaya, Fermented Papaya, Inflammation, Phytochemicals, Physical function, Quality of life, Fatigue, Health

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Body mass index > 25 and < 40 kg/m2;
Willing and able to participate in all aspects of the study;
Self-reported sedentary to moderately active lifestyle (<120 min aerobic activity/week);
Self-reported ability to walk ¼ mile without the use of an assistive device (i.e., cane, walker, crutch);
Mild to Moderate physical impairment (SPPB score 4-10);
Not confined to a wheelchair;
Mini Mental Status Exam score > 24;
Able to swallow study product as directed.

Exclusion Criteria:

Failure to give consent;
Active treatment for cancer (< 3 years);
Stroke (< 6 mo);
Serious heart condition, peripheral vascular disease, coronary artery disease (myocardial infarction<6 mo), Class III, IV Congestive Heart Failure;
Severe anemia (Hgb < 8.0 g/dL);
Liver or renal disease;
Diabetes;
Severe osteoarthritis;
Fracture in upper or lower extremity within the last 6 months;
Upper or lower extremity amputation;
Anticoagulant therapy (aspirin use is permitted);
Parkinson's disease;
Severe psychiatric disease or psychological disorder (e.g., severe depression, bi-polar disorder, schizophrenia) or current use of antipsychotics;
Current use of anabolic medications (e.g., growth hormone or testosterone) or anticholinesterase inhibitor (i.e., Aricept);
High amounts of physical activity (i.e., running, bicycling, etc.) > 120 min/week;
Excessive alcohol use (>2 drinks per day);
Use of tobacco products;
Resting heart rate > 120 bpm;
Blood pressure with Systolic > 160mmHg and Diastolic >90mmHg;
History of significant head injury leading to cognitive impairments;
Visual or hearing impairments that would interfere with testing;
Current consumption of any dietary supplements containing resveratrol, quercetin, or P. cuspidatum, grape seed extract, or ginko biloba;
Allergies to papaya or foods with similar compounds (i.e., banana, avocado, kiwi, chestnuts, hazel nuts)
Allergy to latex;
Participating in another clinical trial or has received an investigational product within 30 days prior to screening/enrollment;
Center for Epidemiological Studies - Depression Scale (CES-D) Score > 20.

Sites / Locations

University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fermented Papaya Preparation (FPP)

Sugar Pill

Arm Description

A total of 9 grams of FPP per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing FPP per day - once 30-40 min before breakfast, once 30-40 min before lunch, and once 30-40 min before dinner. Participants will open the sachet, empty contents into their mouth, and let it dissolve before swallowing.

A total of 9 grams of placebo (sugar) per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing placebo per day - once 30-40 min before breakfast, once 30-40 min before lunch, and once 30-40 min before dinner. Participants will open the sachet, empty contents into their mouth, and let it dissolve before swallowing.

Outcomes

Primary Outcome Measures

Interleukin-6 (IL-6) will be tested at weeks 8 and 20

Blood test performed.

Tumor necrosis factor-α (TNF-α) will be tested at weeks 8 and 20

Blood test will be performed.

C - reactive protein (CRP) will be tested at weeks 8 and 20

Blood test will be performed.

Myeloperoxidase (MPO) will be tested at weeks 8 and 20

Blood test will be performed.

Secondary Outcome Measures

Short Physical Performance Battery

Physical function test to assess functional performance on different tasks including timed short distance walk, repeated chair stands, and a balance test.

6 Minute Walk Test performed at weeks 8 and 20.

The 6 Minute Walk tests functional walking endurance. Participants will be asked to walk at a comfortable pace for 6 minutes. Total distance completed, blood pressure, and pulse rate will be measured.

Health-related quality of life performed at weeks 8 and 20

RAND SF-36 Short Form Health Survey (SF-36) measures eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, vitality (energy/fatigue), emotional well being, bodily pain, social functioning, and general health perceptions.

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) performed at weeks 8 and 20

FACIT-Fatigue is a measure of physical and functional consequences of fatigue, with lower scores indicating more fatigue.

Brief Fatigue Symptom Inventory (FSI)

FSI is a measure of physical and functional consequences of fatigue.

Superoxide dismutases (SOD) tested at weeks 8 and 20.

Blood test will be performed.

Glutathione Peroxidase tested at weeks 8 and 20.

Blood test will be performed.

Total Antioxidant Capacity will be tested at weeks 8 and 20

Blood test will be performed.

Muscle tissue oxygenation tested at weeks 8 and 20

Participants will be asked to perform a leg extension endurance exercise with electrodes placed on their forehead and thigh.

Brain tissue oxygenation tested at weeks 8 and 20

Participants will complete a series of memory and thinking tasks while wearing electrodes on their head. The N-Back Test that measures working memory will be conducted for 10 minutes.

Full Information

NCT ID

NCT02051634

First Posted

January 29, 2014

Last Updated

April 5, 2018

Sponsor

University of Florida

Collaborators

Osato Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02051634

Brief Title

Papaya Study ID:20140628

Official Title

Efficacy of Fermented Papaya Preparation on Markers of Systemic Inflammation

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

Osato Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this research study is to explore the effects of fermented papaya preparation (FPP) on whole body inflammation, physical function, fatigue, and health-related quality of life. The investigators will conduct a double-blind, randomized, placebo-controlled pilot study on FPP in older adults. If FPP is found to have a beneficial impact on systematic inflammation in this study population (adults aged 70-100 years old), then this supplement may be a potential treatment option to combat aging.

Detailed Description

All of the participants in this research study will be divided randomly into one of two groups: (1) a group taking fermented papaya preparation (FPP) for 8 weeks then taking placebo for 8 weeks or (2) a group taking placebo for 8 weeks then taking FPP for 8 weeks. Placebo sachets do not contain any treatment product. Participants will be assigned randomly to be in one of these two groups. Participants will be asked to take study product for 8 weeks each, and participation in the study will last for a total of approximately 22 weeks. Participants will be asked to attend five study visits at the University of Florida's Institute on Aging - Clinical & Translational Research Building (IOA - CTRB): Screening Visit, Visit 1, Visit 2, Visit 3, and Visit 4. Visit 1 will take place approximately 30 days after the Screening Visit. Visit 2 will take place approximately 8 weeks after the Screening Visit. Visit 3 will take place approximately 16 weeks after the Screening Visit. Visit 4 will take place approximately 20 weeks after the Screening Visit. Participants will be asked to fast (i.e., no food or liquids except water) for 8 hours prior to all clinic visits. Each visit will take approximately 1.5 to 2 hours. Participants will also be called weekly during the study to ask how they are feel and to find out and if they remembered to take all of their study product. Finally, investigators will call approximately two weeks after participants stop taking the study product to ask how they are feeling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Inflammation, Aging

Keywords

Aging, Papaya, Fermented Papaya, Inflammation, Phytochemicals, Physical function, Quality of life, Fatigue, Health

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fermented Papaya Preparation (FPP)

Arm Type

Active Comparator

Arm Description

Arm Title

Sugar Pill

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Fermented Papaya Preparation (FPP)

Other Intervention Name(s)

Papaya

Intervention Description

A total of 9 grams of FPP per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing FPP per day - once 30-40 min before breakfast, once 30-40 min before lunch, and once 30-40 min before dinner. Participants will open the sachet, slowly empty contents into their mouth, and let it dissolve before swallowing.

Intervention Type

Drug

Intervention Name(s)

Sugar Pill

Intervention Description

A total of 9 grams of placebo (sugar) per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing placebo per day - once with breakfast, once with lunch, and once with dinner. Participants will open the sachet, empty contents into their mouth, and let it dissolve before swallowing.

Primary Outcome Measure Information:

Title

Interleukin-6 (IL-6) will be tested at weeks 8 and 20

Description

Blood test performed.

Time Frame

Change from 8 weeks and 20 weeks

Title

Tumor necrosis factor-α (TNF-α) will be tested at weeks 8 and 20

Description

Blood test will be performed.

Time Frame

Change from 8 weeks and 20 weeks

Title

C - reactive protein (CRP) will be tested at weeks 8 and 20

Description

Blood test will be performed.

Time Frame

Change from 8 weeks and 20 weeks

Title

Myeloperoxidase (MPO) will be tested at weeks 8 and 20

Description

Blood test will be performed.

Time Frame

Change from 8 weeks and 20 weeks

Secondary Outcome Measure Information:

Title

Short Physical Performance Battery

Description

Physical function test to assess functional performance on different tasks including timed short distance walk, repeated chair stands, and a balance test.

Time Frame

Change from 8 weeks and 20 weeks

Title

6 Minute Walk Test performed at weeks 8 and 20.

Description

Time Frame

Change from 8 weeks and 20 weeks

Title

Health-related quality of life performed at weeks 8 and 20

Description

Time Frame

Change from 8 weeks and 20 weeks

Title

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) performed at weeks 8 and 20

Description

FACIT-Fatigue is a measure of physical and functional consequences of fatigue, with lower scores indicating more fatigue.

Time Frame

Change from 8 weeks and 20 weeks

Title

Brief Fatigue Symptom Inventory (FSI)

Description

FSI is a measure of physical and functional consequences of fatigue.

Time Frame

Change from 8 weeks and 20 weeks

Title

Superoxide dismutases (SOD) tested at weeks 8 and 20.

Description

Blood test will be performed.

Time Frame

Change from 8 weeks and 20 weeks

Title

Glutathione Peroxidase tested at weeks 8 and 20.

Description

Blood test will be performed.

Time Frame

Change from 8 weeks and 20 weeks

Title

Total Antioxidant Capacity will be tested at weeks 8 and 20

Description

Blood test will be performed.

Time Frame

Change from 8 weeks and 20 weeks

Title

Muscle tissue oxygenation tested at weeks 8 and 20

Description

Participants will be asked to perform a leg extension endurance exercise with electrodes placed on their forehead and thigh.

Time Frame

Change from 8 weeks and 20 weeks

Title

Brain tissue oxygenation tested at weeks 8 and 20

Description

Participants will complete a series of memory and thinking tasks while wearing electrodes on their head. The N-Back Test that measures working memory will be conducted for 10 minutes.

Time Frame

Change from 8 weeks and 20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Body mass index > 25 and < 40 kg/m2; Willing and able to participate in all aspects of the study; Self-reported sedentary to moderately active lifestyle (<120 min aerobic activity/week); Self-reported ability to walk ¼ mile without the use of an assistive device (i.e., cane, walker, crutch); Mild to Moderate physical impairment (SPPB score 4-10); Not confined to a wheelchair; Mini Mental Status Exam score > 24; Able to swallow study product as directed. Exclusion Criteria: Failure to give consent; Active treatment for cancer (< 3 years); Stroke (< 6 mo); Serious heart condition, peripheral vascular disease, coronary artery disease (myocardial infarction<6 mo), Class III, IV Congestive Heart Failure; Severe anemia (Hgb < 8.0 g/dL); Liver or renal disease; Diabetes; Severe osteoarthritis; Fracture in upper or lower extremity within the last 6 months; Upper or lower extremity amputation; Anticoagulant therapy (aspirin use is permitted); Parkinson's disease; Severe psychiatric disease or psychological disorder (e.g., severe depression, bi-polar disorder, schizophrenia) or current use of antipsychotics; Current use of anabolic medications (e.g., growth hormone or testosterone) or anticholinesterase inhibitor (i.e., Aricept); High amounts of physical activity (i.e., running, bicycling, etc.) > 120 min/week; Excessive alcohol use (>2 drinks per day); Use of tobacco products; Resting heart rate > 120 bpm; Blood pressure with Systolic > 160mmHg and Diastolic >90mmHg; History of significant head injury leading to cognitive impairments; Visual or hearing impairments that would interfere with testing; Current consumption of any dietary supplements containing resveratrol, quercetin, or P. cuspidatum, grape seed extract, or ginko biloba; Allergies to papaya or foods with similar compounds (i.e., banana, avocado, kiwi, chestnuts, hazel nuts) Allergy to latex; Participating in another clinical trial or has received an investigational product within 30 days prior to screening/enrollment; Center for Epidemiological Studies - Depression Scale (CES-D) Score > 20.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen D Anton, PhD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Papaya Study ID:20140628

We'll reach out to this number within 24 hrs