An Evaluation of the Effects of a Non-Caffeinated Energy Dietary Supplement

Health Behavior Clinical Trial

Official title:

An Evaluation of the Effects of a Non-Caffeinated Energy Die-tary Supplement on Cognitive and Physical Performance: A Randomized Double-Blind Placebo-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04895800
• Other study ID #: 2019-563
• Status: Completed
• Phase: N/A
• Start date: January 3, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: June 2021
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study tested the effects of a botanical blend to a caffeine and a placebo condition on 1) self-reported alertness, anxiety, and headaches 2) multiple measures of attention 3) physical performance and 4) stress biomarkers.

Description:

This study aimed to build on this work by investigating the possibility that a specific botanical blend (Phytovive™); comprised of Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins) could improve cognitive and physical performance. To this end, this study was a randomized, double-blind, placebo-controlled 21-day parallel study on 36 healthy adults. The study compared the effects of the botanical blend at baseline to a caffeine and a placebo condition on 1) self-reported alertness, anxiety, and headaches 2) multiple measures of attention 3) physical performance and 4) stress biomarkers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 15, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Adult males and females from 18 to 50 years (inclusive) of age who are physically active and have been engaging in athletic and sporting endeavors consistently over a period of 6 months at minimum

• BMI 18.0 (normal) to 34.9 (obese, class I) kg/ m2 inclusive

• Agrees to maintain a stable lifestyle with no change in exercise or diet for the duration of the study

• Current consumer of caffeine either through caffeinated beverages or foods

• Non-smoker

• Able to physically exercise, to run on a treadmill at moderate to high intensity for a brief time (typically less than 20 min)

• Participants with normal blood pressure or participants with hypertension that is controlled (BP < 160/90 and who are on medication at a stable dose (same dose for =90 days)

• Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, carry out all study-related procedures, communicate effectively with the study staff.

• Females must be using an acceptable method of contraception such as: abstinence, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream), intrauterine device or hormonal contraception (oral, injectable, implantable, transdermal, or vaginal) used consecutively for at least 3 months prior to screening visit, vasectomized partner or use of implants for at least 6 months prior to screening visit; bilateral tubal ligation, hysterectomy, bilateral oophorectomy, or be postmenopausal status with amenorrhea (no menses) for at least 1 year prior to the screening visit.

Exclusion Criteria:

• Have a known sensitivity or allergy to any of the study products or their ingredients

• Have any medical condition or disease based on the professional judgement and experience of the principal investigator (PI) plus research industry standards that might affect or impact the administration of study products

• Lactating, pregnant or planning to become pregnant during the study

• History of drug or alcohol abuse in the 12 months prior to screening

• History of psychiatric illness requiring hospitalization in the 6 months prior to screening

• History of diabetes (Type I or II) or uncontrolled hypertension (either systolic BP >160 or diastolic BP >90)

• Participation in or use of a research IP within 30 days prior to screening (cannot have been in another study within 30 days of screening)

Related Conditions & MeSH terms

• Health Behavior

Intervention

Dietary Supplement:
• Phytovive
Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins)
• Placebo
Natural Flavors [Chocolate, Caramel, Vanilla Cream], Silica, Inulin, Sucralose)
• Caffeine
Caffeine (Green tea caffeine extract (170 mg; to deliver 34 mg caffeine [20% natural caf-feine])

Locations

Country	Name	City	State
United States	Nova Southeastern University	Davie	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nova Southeastern University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Heaton RK, Akshoomoff N, Tulsky D, Mungas D, Weintraub S, Dikmen S, Beaumont J, Casaletto KB, Conway K, Slotkin J, Gershon R. Reliability and validity of composite scores from the NIH Toolbox Cognition Battery in adults. J Int Neuropsychol Soc. 2014 Jul;20(6):588-98. doi: 10.1017/S1355617714000241. Epub 2014 Jun 24. — View Citation

Kongkeaw C, Dilokthornsakul P, Thanarangsarit P, Limpeanchob N, Norman Scholfield C. Meta-analysis of randomized controlled trials on cognitive effects of Bacopa monnieri extract. J Ethnopharmacol. 2014;151(1):528-35. doi: 10.1016/j.jep.2013.11.008. Epub 2013 Nov 16. Review. — View Citation

Pickering C, Kiely J. What Should We Do About Habitual Caffeine Use in Athletes? Sports Med. 2019 Jun;49(6):833-842. doi: 10.1007/s40279-018-0980-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition	Cognitive performance on the NIH Toolbox Cognition Battery and Joggle Psychomotor Vigilance Task. T scores (higher is better) will be reported.	21 days
Primary	Mood	Self-reported Mood using the Mood and Physical Sensation Scale (higher scores reflect better mood)	21 Days
Primary	Physical Performance	Time to Exhaustion (TTE) Test - running on a treadmill with an increased incline every minute until perceived exhaustion is reached	21 Days