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

NCT ID: NCT04895800

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-03
• Study Completion Date: 2021-03-15

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.

Conditions

Health Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Herbal Supplement

(Phytovive™); comprised of Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins)

Group Type: EXPERIMENTAL

Phytovive

Intervention Type: DIETARY_SUPPLEMENT

Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins)

Caffeine

Green tea caffeine extract (170 mg; to deliver 34 mg caffeine \[20% natural caffeine\]),

Group Type: ACTIVE_COMPARATOR

Caffeine

Intervention Type: DIETARY_SUPPLEMENT

Caffeine (Green tea caffeine extract (170 mg; to deliver 34 mg caffeine \[20% natural caf-feine\])

Placebo

Flavored placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Natural Flavors \[Chocolate, Caramel, Vanilla Cream\], Silica, Inulin, Sucralose)

Interventions

Phytovive

Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Natural Flavors \[Chocolate, Caramel, Vanilla Cream\], Silica, Inulin, Sucralose)

Intervention Type: DIETARY_SUPPLEMENT

Caffeine

Caffeine (Green tea caffeine extract (170 mg; to deliver 34 mg caffeine \[20% natural caf-feine\])

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Southeastern University

OTHER

Sponsor Role: lead

Responsible Party

Jaime Tartar

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaime Tartar, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

Nova Southeastern University

Davie, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24252493 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24960398 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30173351 (View on PubMed)

Other Identifiers

2019-563

Identifier Type: -

Identifier Source: org_study_id