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Effects of a Polyherbal Supplement on the Signs and Symptoms of Delayed Onset Muscle Soreness

Primary Purpose

Delayed Onset Muscle Soreness

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Polyherbal capsule

Placebo capsule

About this trial

This is an interventional basic science trial for Delayed Onset Muscle Soreness focused on measuring Delayed onset muscle soreness, Muscle damage, Eccentric exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

≥ 18 years of age
be in good general health without clinically significant disease, as determined by medical history, physical examination, and urine drug screens
body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
females of child bearing potential must agree to use appropriate birth control methods during the entire study period
agree not to initiate any new exercise or diet programs during the entire study period
agree not to change their current diet or exercise program during the entire study period
understand the study procedures and sign the forms providing informed consent to participate in the study, and authorize the release of relevant protected health information of the study investigator
agree not to stretch, utilize ice massage, take anti-inflammatory medications (eg, aspirin, ibuprofen), or use any other treatment for the duration of the trial.

Exclusion Criteria:

previous history of upper extremity injury or pain
use of anti-inflammatory medications or pain medications beginning at the screening visit and during the study
daily use of dietary supplements and herbal supplements beginning at the screening visit and during the study
use of any immunosuppressive drugs or biologic products in the last 12 months (including steroids [except for inhaled and topical dose forms]);
antibiotic use, anticoagulants, intra-articular steroids in past 3 months
any significant GI condition that would potentially interfere with the evaluation of the study product including but not limited to inflammatory bowel disease (ulcerative colitis or Crohn's), history of lap band surgery, history of perforation of the stomach or intestines, or gastroparesis
clinically significant renal, hepatic and biliary, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic (particularly balance or neuropathy problems), hematologic disorder, or significant mental health disorder
known allergy or sensitivity to herbal ingredients in the test products, olive oil, or soy
history or presence of cancer in the last 5 years (except basal cell carcinoma of skin or in-situ cervical cancer)
recent history of (within 2 years) or strong potential for alcohol or substance abuse
participation in a clinical study with exposure to any non-registered drug product within 30 days prior to this study
report use of tobacco or products containing nicotine
individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk, including subjects who are bed or wheelchair-bound or those who have any physical disability which could interfere with their ability to perform the exercise assessments included in this protocol.

Sites / Locations

University of Vermont

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Polyherbal capsule

Placebo capsule

Arm Description

Subjects take 1 capsule with breakfast and 1 capsule with lunch. Subjects should take capsules immediately prior to meals and not with carbonated beverages.

Outcomes

Primary Outcome Measures

Change from baseline in peak muscle strength on Day 2 of each test period after eccentric exercise.

This procedure utilizes 3 sets of 1 repetition of maximal isometric contractions of the arm recorded in pounds and averaged across the 3 sets.

Secondary Outcome Measures

Change from baseline in peak muscle strength after eccentric exercise

Change from baseline in pain assessment after eccentric exercise

Pain will be assessed verbally during elbow flexion and extension using a 10-point Likert scale (with 1 = normal, no discomfort and 10 = very uncomfortable).

Change from baseline in flexibility after eccentric exercise

Flexibility of the biceps muscle group will be evaluated with the arm hanging freely at the subject's side. The relaxed extension will be measured using an electronic level and electronic goniometer placed at the elbow.

Change from baseline in elbow girth (swelling) after eccentric exercise

Girth measurements will be taken around the elbow.

Change from baseline in muscle tenderness after eccentric exercise

Muscle tenderness scores will be assessed using a standard manual muscle myometer. Decreasing force application after baseline indicates increasing tenderness, a reflection of muscle damage.

Change from baseline in creatinine kinase (CK) and C-reactive protein (CRP) levels after eccentric exercise

Full Information

NCT ID

NCT02157675

First Posted

June 4, 2014

Last Updated

October 12, 2015

Sponsor

NewChapter, Inc.

Collaborators

Procter and Gamble

1. Study Identification

Unique Protocol Identification Number

NCT02157675

Brief Title

Effects of a Polyherbal Supplement on the Signs and Symptoms of Delayed Onset Muscle Soreness

Official Title

The Effects of a Polyherbal Supplement on the Signs and Symptoms of Delayed Onset Muscle Soreness: a 2-arm, Randomized, Double-blind, Placebo-controlled, Crossover Design Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NewChapter, Inc.

Collaborators

Procter and Gamble

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is a randomized, double-blind, placebo-controlled, crossover design study in healthy subjects to determine the effects of a polyherbal supplement on the signs and symptoms of delayed onset muscle soreness (DOMS) induced by eccentric exercise of the arm.

Detailed Description

Approximately 30 subjects will be enrolled. The study includes a 19-day treatment period and a minimum 7-day washout period in which no test product is administered. Subjects will then crossover to a second 19-day treatment period to complete the study. Subjects receive test product (polyherbal capsule or placebo capsule) daily during the treatment periods. Two exercise test sessions followed up to 5 days will occur during the study using a modified seated arm-curl bench. Muscle strength is assessed on each day of the 5-day exercise test period. Safety is assessed during the study by collecting adverse events (AEs), clinical laboratory data (serum hematology and chemistry), and vital signs (blood pressure, pulse, respiration rate, temperature).

6. Conditions and Keywords

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

Delayed Onset Muscle Soreness

Keywords

Delayed onset muscle soreness, Muscle damage, Eccentric exercise

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Polyherbal capsule

Arm Type

Experimental

Arm Description

Subjects take 1 capsule with breakfast and 1 capsule with lunch. Subjects should take capsules immediately prior to meals and not with carbonated beverages.

Arm Title

Placebo capsule

Arm Type

Placebo Comparator

Arm Description

Subjects take 1 capsule with breakfast and 1 capsule with lunch. Subjects should take capsules immediately prior to meals and not with carbonated beverages.

Intervention Type

Dietary Supplement

Intervention Name(s)

Polyherbal capsule

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo capsule

Primary Outcome Measure Information:

Title

Change from baseline in peak muscle strength on Day 2 of each test period after eccentric exercise.

Description

This procedure utilizes 3 sets of 1 repetition of maximal isometric contractions of the arm recorded in pounds and averaged across the 3 sets.

Time Frame

Day 2 of each 5-day test period (ie, 48 hours after the eccentric exercise procedure to induce DOMS on Day 0)

Secondary Outcome Measure Information:

Title

Change from baseline in peak muscle strength after eccentric exercise

Time Frame

Up to 5 days following eccentric exercise.

Title

Change from baseline in pain assessment after eccentric exercise

Description

Pain will be assessed verbally during elbow flexion and extension using a 10-point Likert scale (with 1 = normal, no discomfort and 10 = very uncomfortable).

Time Frame