Functional Drink Energy and Focus Clinical Trial and Research Services

A functional drink is a beverage that contains ingredients related to health or body function, rather than being intended only to quench thirst or refresh. Energy and focus drinks, such as drinks containing caffeine with L-theanine, vitamin B complex or ginseng extract, come as ready-to-drink beverages, shots and powders for mixing. A clinical trial for drinks in this group compares perceived energy, alertness, focus and fatigue between people who drink the test beverage and people who drink a placebo beverage under controlled conditions.

The market for energy and focus health drinks continues to grow in Thailand and worldwide. Working-age consumers and students are looking for drinks that help with perceived energy and focus rather than momentary refreshment. Brand owners who want to communicate these effects on labels or in marketing materials need scientific evidence to support those statements, and food advertising must comply with the Food Act B.E. 2522 (1979), including advertising approval where the law requires it. Drinks containing caffeine are also subject to specific requirements on composition, labeling and advertising, which must be checked before communication is planned.

The main challenge in developing drinks in this group is showing that the product affects energy and focus under real conditions, which relies mainly on patient-reported outcome measures (PROMs) that have been developed and validated. VISBIO Co., Ltd. provides study design, project management and project coordination for clinical studies of energy and focus functional drinks, in collaboration with a network of partner clinical research sites and hospitals, from protocol planning to the final report, under Good Clinical Practice (GCP), for sponsors in Thailand and abroad.

Under the Food Act B.E. 2522 (1979), the Thai Food and Drug Administration (Thai FDA) authorizes drinks mainly on the basis of product safety and quality; authorization does not confirm effects on energy, focus or fatigue as communicated in marketing. The food registration number (Thai FDA number) on the label is therefore not evidence that a drink has those effects, and communicating effects without supporting evidence risks breaching food advertising law.

Market trends are making this clearer. Younger consumers are better informed and increasingly question statements about energy and focus, while some modern trade buyers, distributors and export partners have begun to ask for supporting scientific documents before they accept products for sale.

A clinical study is designed to build this empirical evidence directly, by comparing energy, focus and fatigue between a group receiving the test drink and a group receiving a placebo drink, under conditions controlled according to GCP. The data support product development and evidence-based communication.

Energy and focus drinks vary widely in both ingredients and mechanisms of action. Common ingredients include caffeine, which is often combined with L-theanine in formulas aimed at alertness and focus; B vitamins, which are involved in cellular energy production; and adaptogenic herbal extracts such as ginseng, on which there is a body of research on stress and fatigue.

Clinical research on drinks in this group is using more rigorous designs. O’Shea et al. (2025) conducted a randomized, double-blind, placebo-controlled, crossover trial in 37 healthy adults aged 18–30 years. Participants drank a functional energy shot containing caffeine, ginseng, vitamins and taurine, or a taste-matched placebo drink, on test days one week apart, and cognitive performance and mood were measured repeatedly over about 2 hours after drinking. With the test drink, cognitive performance was better than with the placebo to a statistically significant degree, and mental fatigue during sustained cognitively demanding tasks was reduced. This work illustrates issues specific to beverage studies: making the placebo drink taste the same as the test drink, measuring outcomes within a short period after each drink, and choosing appropriate focus endpoints, all of which directly affect the credibility of the evidence.

The challenge in measuring energy and focus is that most primary endpoints are subjective, whether perceived energy, alertness or focus, so assessment tools that have been developed and validated must be used. Chalder et al. (1993) developed a 14-item Fatigue Scale that distinguishes physical and mental fatigue and is widely used in clinical studies, while Lee et al. (1991) tested the validity and reliability of the Visual Analog Scale for Fatigue (VAS-F), which has 18 items on fatigue and energy. Both are examples of scales used in research on energy and fatigue.

Every study follows GCP and takes into account the particular nature of measuring energy and focus, which relies mainly on questionnaires completed by the participants themselves. VISBIO designs the study and manages it from planning to delivery of the report, while volunteers are recruited and cared for by the physicians and investigators of the research site responsible for the study.

Step 1: Consultation and protocol design

Together with the investigators of a partner research site, VISBIO reviews the drink’s characteristics, the effects the sponsor wants to claim and the purpose of the product, in order to define a suitable study plan, including the choice of a primary endpoint for energy, fatigue and focus as rated by the participants themselves. This step covers setting inclusion and exclusion criteria that fit the claim, and estimating a sample size with adequate statistical power.

Step 2: Approval from the human research ethics committee

Before any data are collected, the protocol and the informed consent documents must in every case be approved by a human research ethics committee (Institutional Review Board: IRB). VISBIO coordinates document preparation with the site’s investigators and follows up on revisions requested by the committee until approval is granted.

Step 3: Volunteer recruitment and screening

Once approval is granted, the research site responsible for the study recruits and screens volunteers according to the protocol. The site’s physicians and investigators make sure that every volunteer receives complete information, gives written consent and passes a health screening before joining the study. VISBIO coordinates schedules and study readiness between the sponsor and the research site.

Step 4: Study conduct and data collection

Volunteers receive the test drink or the placebo drink, and data are collected at the time points set in the protocol, using standard assessment tools accepted in clinical research, such as self-rated fatigue scales, visual analog scales (VAS) for energy and alertness, and mood questionnaires, together with recording of adverse events throughout the study. The site’s investigators assess the volunteers and look after their safety, while VISBIO, as project manager, monitors progress and the completeness of the data.

Step 5: Data analysis and reporting

All data are analyzed statistically according to a statistical analysis plan (SAP) set in advance and summarized in a complete scientific report in an internationally used format. VISBIO coordinates the analysis and delivers the report to the sponsor. The report supports product development and evidence-based communication.

This service is designed for health drinks in various formats that aim to communicate about energy and focus. Examples of suitable ingredient types and product formats are shown below.

Some markets permit ingredients such as ashwagandha in functional drinks and food supplements under local regulations; study designs follow the rules of the target market.

Evidence from a clinical study is not just a regulatory document. It is a strategic asset that owners of health drink brands can use to create value in several ways.

Premium product positioning

A drink with clinical study data can be positioned in the premium segment on a reasoned and credible basis. In a market where consumers increasingly question statements about energy and focus, outcomes actually measured with standard tools in the group that received the test drink, compared with a control group, give the product’s value proposition a data foundation and set it apart from competitors without such data.

Negotiations with modern trade and e-commerce channels

Many e-commerce platforms and modern trade buyers in the health and energy categories ask for supporting scientific documents. A clinical study report prepared under GCP makes negotiations and product listing in these channels smoother.

Lower legal risk and expansion into export markets

Statements about energy and focus that are supported by clinical study evidence reduce the risk that advertising will be considered exaggerated under the Food Act B.E. 2522 (1979). In addition, a study designed and reported to international practice is part of preparing to enter export markets, and each country has its own requirements.

Using scientific data in marketing communication

Data actually measured in a clinical study can be used across several communication channels. Advertising use, however, requires proper advertising approval from the Thai FDA before publication, as required by law.

1. Drinks sold in Thailand must already have a food registration number (Thai FDA number) before the study starts. For products of sponsors from abroad, VISBIO assesses the legal conditions together with the research site on a project-by-project basis.
2. VISBIO and the research site design the study plan specifically for each product and its claim.
3. Every study must be approved by a human research ethics committee before it starts, without exception.

For brands that want evidence at every level, VISBIO supports work from quantitative analysis of key compounds in the product, such as vitamin B12 and key compounds in black ginger, and initial activity testing at the cellular level (In Vitro), through to clinical studies in volunteers. GCP applies to studies in humans, while laboratory work follows the test method for each assay. Planning every level of evidence with a single coordinator keeps the data from each stage consistent and leaves no gaps.

What is a functional drink?

A functional drink is a beverage that contains ingredients related to health or body function, rather than being intended only to quench thirst or refresh. Energy and focus drinks often contain ingredients such as caffeine with L-theanine, vitamin B complex or ginseng extract, as ready-to-drink beverages, shots or powders for mixing.

Does a drink’s Thai FDA number confirm effects on energy and focus?

No. Thai FDA authorization under the Food Act is based mainly on product safety and quality. If you want to communicate effects on energy or focus, clinical data provide supporting evidence, and advertising must still comply with food law.

Which tools are used to measure energy and focus?

Questionnaires completed by the volunteers themselves, such as the Chalder Fatigue Scale, the Visual Analog Scale for Fatigue (VAS-F) and energy and alertness scales, together with mood questionnaires and recording of adverse events throughout the study.

Why compare with a placebo drink?

Perceived energy and focus are endpoints rated by the participants themselves. Comparing with a taste-matched placebo drink, with neither participants nor investigators knowing which drink was taken, helps separate the effect of the test drink from other factors, such as the drinker’s expectations.

What is VISBIO’s role in a study, and who looks after the volunteers?

VISBIO designs the study and provides project management and coordination in collaboration with a network of partner clinical research sites and hospitals. Volunteers are recruited and cared for by the physicians and investigators of the research site responsible for the study.

Do study results guarantee advertising approval?

No. Study results support product development and evidence-based communication. Use on labels or in advertising must comply with the law, with approval from the relevant authorities where the law requires it. VISBIO does not guarantee study outcomes or regulatory decisions.

If you are interested in clinical research for your energy and focus functional drink, contact VISBIO for a free initial consultation through any of these channels:

• Contact form: https://visbio.co.th/en/contact-us/
• LINE Official Account: @visbio
• Email: service@visbio.co.th
• Phone: 098-635-4197
• Timeline: please ask our team directly.

See all clinical trial services on VISBIO’s clinical trial service page.

• VISBIO’s role: VISBIO designs studies and provides project management and project coordination in collaboration with a network of partner clinical research sites and hospitals, for sponsors in Thailand and abroad. Volunteers are recruited and cared for by the physicians and investigators of the research site responsible for the study.
• Research ethics: Every study in humans starts only after approval by a human research ethics committee and is conducted under Good Clinical Practice (GCP). Every volunteer signs an informed consent form after receiving complete information.
• Drugs and herbal medicines: Studies must follow the Thai FDA requirements that apply to the product. The sponsor, the research site and VISBIO plan these steps together from the start of the project.
• Use of results: Study results support product development and evidence-based communication. Use on labels or in advertising must comply with the law for each product type, with approval from the relevant authorities where the law requires it. VISBIO does not guarantee study outcomes or regulatory decisions.
• Foods and dietary supplements: Study results are not a claim that a product diagnoses, treats, cures, mitigates or prevents any disease.
• Timeline: This depends on the study design and the approval process. Please ask our team directly.

References:

1. Chalder, T., Berelowitz, G., Pawlikowska, T., Watts, L., Wessely, S., Wright, D., & Wallace, E. P. (1993). Development of a fatigue scale. Journal of Psychosomatic Research, 37(2), 147–153. https://doi.org/10.1016/0022-3999(93)90081-P
2. Lee, K. A., Hicks, G., & Nino-Murcia, G. (1991). Validity and reliability of a scale to assess fatigue. Psychiatry Research, 36(3), 291–298. https://doi.org/10.1016/0165-1781(91)90027-M
3. O’Shea, O. K., Lawley, N., Azzopardi, A., Gutkowski, A., Niedziela, M. M., Horn, R., Kennedy, D. O., & Adamson, J. (2025). Acute beneficial effects of a functional energy shot on cognitive performance and mood states during cognitively demanding task performance: A randomized, double-blind, placebo-controlled, crossover trial. Frontiers in Nutrition, 11, 1496092. https://doi.org/10.3389/fnut.2024.1496092