Papaya Study ID:20140628

NCT02051634 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IRB20140628
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Inflammation; Aging

Keywords

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

Outcome Measures

Primary Outcomes (4)

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

  Blood test performed.

  Change from 8 weeks and 20 weeks

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

  Blood test will be performed.

  Change from 8 weeks and 20 weeks

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

  Blood test will be performed.

  Change from 8 weeks and 20 weeks

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

  Blood test will be performed.

  Change from 8 weeks and 20 weeks

Secondary Outcomes (10)

• Short Physical Performance Battery

  Change from 8 weeks and 20 weeks

• 6 Minute Walk Test performed at weeks 8 and 20.

  Change from 8 weeks and 20 weeks

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

  Change from 8 weeks and 20 weeks

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

  Change from 8 weeks and 20 weeks

• Brief Fatigue Symptom Inventory (FSI)

  Change from 8 weeks and 20 weeks

Study Arms (2)

Fermented Papaya Preparation (FPP)

ACTIVE COMPARATOR

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.

Drug: Fermented Papaya Preparation (FPP); Drug: Sugar Pill

Sugar Pill

PLACEBO COMPARATOR

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.

Drug: Fermented Papaya Preparation (FPP); Drug: Sugar Pill

Interventions

Fermented Papaya Preparation (FPP) DRUG

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.

Also known as: Papaya

Fermented Papaya Preparation (FPP); Sugar Pill

Sugar Pill DRUG

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.

Fermented Papaya Preparation (FPP); Sugar Pill

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Florida: lead
• Osato Research Institute: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Inflammation; Fatigue

Interventions

fermented papaya preparation; Sugars

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Stephen D Anton, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: January 31, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

US (1)