Effects of Herbal Supplements on Endurance Exercise Performance

• Sponsor: California Polytechnic State University-San Luis Obispo (Other)
• Overall Status: Completed
• CT.gov ID: NCT03929575
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arms: 3
• Actual Duration (Months): 7
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

Cordyceps and Rhodiola are two common herbal supplements marketed and consumed as adaptogens to athletes with regard to enhanced performance. The effects of these supplements has been well studied in animals but whether or not the same effects translate to humans is still unclear. Thus, the primary purpose of this study is to determine whether combined supplementation of Rhodiola and Cordyceps, compared to Rhodiola alone and placebo, will demonstrate a greater improvement in oxygen consumption (ie. VO2 max).

Condition or Disease	Intervention/Treatment	Phase
Exercise Performance	Dietary Supplement: Placebo of calcium; Dietary Supplement: Rhodiola; Dietary Supplement: Rhodiola and Cordyceps	N/A

Detailed Description

Herbal supplements are consumed worldwide with surveys approximating five billion dollars spent annually by consumers in the United States alone. Herbal supplements, such as Rhodiola and Cordyceps, both of which are considered to be adaptogens, remain popular among athletes. These adaptogens act as antioxidants, which have been speculated to confer endurance performance benefits by delaying muscle fatigue via the attenuation of muscle damage accumulation and its related by-products during prolonged or exhaustive exercise. Nevertheless, previous research investigating the individual effects of Rhodiola and Cordyceps on aerobic training performance remain equivocal. Moreover, literature elucidating the potential additive effects of Rhodiola and Cordyceps in human subjects are scarce. Therefore, the purpose of the present study is to determine the acute, additive influence of oral Rhodiola and Cordyceps supplementation on VO2 max, with secondary variables of interest being plasma glucose and lactate concentration, and measures of gastrointestinal distress.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Blocked-randomized, crossover designBlocked-randomized, crossover design
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effects of Herbal Supplements on Endurance Exercise Performance
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo of calcium Participants will consume 250 mg of calcium	Dietary Supplement: Placebo of calcium; Ingestion of 250 mg of calcium
Experimental: Rhodiola Participants will consume 250 mg of Rhodiola	Dietary Supplement: Rhodiola; Ingestion of 250 mg of Rhodiola
Experimental: Rhodiola and Cordyceps Participants will consume a combination of 250 mg of Rhodiola and 225 mg of Cordyceps	Dietary Supplement: Rhodiola and Cordyceps; Ingestion of 250 mg of Rhodiola and 225 mg of Cordyceps

Outcome Measures

Primary Outcome Measures

1. VO2 max [90 minutes after baseline]

   Maximum oxygen consumption using the Bruce Protocol

Secondary Outcome Measures

1. Gastrointestinal symptoms questionnaire [Baseline, 90 minutes, 110 minutes]

   Section 1 contains 6 questions assessing upper abdominal problems (reflux, heartburn, bloating, cramps, vomiting, and nausea). Section 2 contains 7 questions assessing lower abdominal problems (intestinal cramps, flatulence, urge to defecate, left abdominal pain, right abdominal pain, loose stool, and diarrhea). Section 3 contains 4 questions assessing systematic problems (dizziness, headache, muscle cramp, and urge to urinate). Each of the 17 questions is answered using a 10-point scale ranging from 0 (no problem at all) to 10 (the worst it has ever been). Each of the 3 sections will be scored separately. Section 1 will be scored on a scale of 0-60. Section 2 will be scored on a scale of 0-70. Section 3 will be scored on a scale of 0-40.

2. Blood glucose [Baseline, 90 minutes, 110 minutes]

   Plasma glucose assessed by finger stick

3. Blood lactate [Baseline, 90 minutes, 110 minutes]

   Plasma lactate assessed by finger stick

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Body Mass Index between 18.5 and 35 kg/m^2

• Non-smoking (assessed by Health History Questionnaire)

• English-speaking

• Regular participation in physical activity (>4 hours per week)

Exclusion Criteria:

• Medical conditions that prohibit physical activity (assessed by Health History Questionnaire)

• Pregnant women or women expecting/trying to become pregnant

• BMI greater than or equal to 35 kg/m^2

• Current smoker (assessed by Health History Questionnaire)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Polytechnic State University	San Luis Obispo	California	United States	93407

Sponsors and Collaborators

• California Polytechnic State University-San Luis Obispo

Investigators

• Principal Investigator: Todd Hagobian, PhD, California Polytechnic State University-San Luis Obispo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Todd Hagobian, Principal Investigator, California Polytechnic State University-San Luis Obispo
• ClinicalTrials.gov Identifier: NCT03929575
• Other Study ID Numbers: CPKINE454
• First Posted: Apr 29, 2019
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Calcium

Study Results

No Results Posted as of Jan 27, 2021