Clinical trial NCT04895800: An Evaluation of the Effects of a Non-Caffeinated Energy Dietary Supplement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Double-Blind Placebo-Controlled Study
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cognition
timeFrame: 21 days
measure: Mood
timeFrame: 21 Days
measure: Physical Performance
timeFrame: 21 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Davie
country: United States
facility: Nova Southeastern University
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Jaime Tartar, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.