Energy and Fatigue Supplement Clinical Trial Services

An energy supplement is a dietary supplement developed to support energy levels and reduce feelings of tiredness in daily life. Common ingredients include coenzyme Q10, B-complex vitamins and plant extracts such as ginseng. An energy supplement clinical trial measures the fatigue and energy levels that volunteers perceive using standard assessments, and compares a group that receives the product with a group that receives a placebo.

Feeling tired and low on energy in daily life is common among working adults, students and older people, so the market for energy supplements continues to grow in Thailand and worldwide. Brand owners who want to state on a label or in marketing materials that a product “helps boost energy” or “helps reduce tiredness” must have scientific evidence for that statement, and food advertising must comply with the Food Act B.E. 2522 (1979), including advertising approval where the law requires it.

Measuring energy and fatigue outcomes is complex because the main outcomes are feelings that the consumer perceives (subjective). They must therefore be measured with fatigue assessments that have been validated internationally, and some projects may add objective endpoints. VISBIO Co., Ltd. provides study design, project management and project coordination for clinical studies of these products, working with a network of partner clinical research sites and hospitals under Good Clinical Practice (GCP). The service runs from planning the study protocol to the final report, for sponsors in Thailand and abroad.

Under the Food Act B.E. 2522 (1979), the approval of dietary supplements by the Thai Food and Drug Administration (Thai FDA) focuses mainly on product safety and quality and does not confirm clinical efficacy. The food serial number (Thai FDA number) is therefore not evidence that a product has the stated effect on energy levels or tiredness.

This gap matters to brand owners, especially in a market where “energy” claims are widespread and younger consumers are better informed and increasingly ask whether these products “really work”. At the same time, some modern trade retailers and export partners have started to request supporting scientific documents before they list a product.

A clinical trial is designed to generate exactly this empirical evidence, by comparing fatigue and energy levels between a group that receives the product and a group that receives a placebo under controlled conditions in line with GCP. The resulting data support product development and evidence-based communication.

This product category covers a wide range of active ingredients. One of the most studied herbs is ashwagandha (Withania somnifera), an herb used in Ayurvedic medicine. Chandrasekhar et al. (2012) studied 64 adults with a history of ongoing stress in a randomized, double-blind, placebo-controlled trial. The group that received 300 mg of ashwagandha root extract twice daily for 60 days had lower scores on all stress assessment scales and lower serum cortisol than the placebo group. This study measured stress and anxiety rather than fatigue directly, but it is an example of a design that combines self-rated assessments with biochemical endpoints.

Coenzyme Q10 (CoQ10) is another compound studied in the context of fatigue. Mizuno et al. (2008) conducted a double-blind, placebo-controlled crossover study in 17 healthy volunteers who took 100 or 300 mg of CoQ10 daily for 8 days and then cycled on a bicycle ergometer at a set workload. The group that took 300 mg per day reported less fatigue on a visual analog scale (VAS) after the workload and after the recovery period than the placebo group, and showed better physical performance during the workload. This study is an example of measuring fatigue from physical activity under a controlled workload.

The main challenge in designing studies for this category is choosing endpoints that reflect consumers’ perceptions, such as feelings of fatigue and energy levels, and that match the claim the brand owner wants to substantiate. The Chalder Fatigue Scale is a 14-item self-rated scale whose validity and reliability have been tested, and it separates physical from mental fatigue (Chalder et al., 1993). Objective endpoints, such as blood biochemistry, can be added when the claim and the protocol call for them. A well-designed protocol is therefore the most important starting point.

Every study follows GCP and takes into account the particular nature of energy and fatigue outcomes, which rely mainly on patient-reported outcome measures (PROMs). VISBIO designs the study and manages it from planning through 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

VISBIO analyzes the product’s characteristics, the outcomes the company wants to claim and the product’s objectives together with the investigators of the partner research site to define a suitable study plan, including the choice of a primary endpoint for energy and fatigue. This step covers volunteer inclusion/exclusion criteria that suit the claim and a sample size estimation that gives adequate statistical power.

Step 2: Approval from a human research ethics committee

Before any data are collected, the protocol and the informed consent documents must be approved by a human research ethics committee (Institutional Review Board, IRB) in every case. VISBIO coordinates the preparation of the complete document set with the site’s investigators and follows up on the 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 criteria in the protocol. The site’s physicians and investigators make sure that every volunteer receives complete information, gives written informed consent and passes health screening before joining the study. VISBIO coordinates schedules and project readiness between the sponsor and the research site.

Step 4: Study conduct and data collection

Volunteers receive the product, and data are collected at the time points set in the protocol using standard assessment tools accepted in international clinical research, such as the Chalder Fatigue Scale (Chalder et al., 1993) and VAS ratings of energy and fatigue, together with adverse event recording throughout the study. The site’s investigators assess and safeguard volunteer safety, while VISBIO, as project manager, monitors progress and data completeness. If the protocol includes blood biochemistry endpoints, blood samples are collected by the staff of the research site responsible for the study.

Step 5: Data analysis and reporting

All data are analyzed statistically according to the statistical analysis plan (SAP) set at the design stage and summarized in a full 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 dietary supplements in various formats that aim to communicate benefits related to energy and fatigue. Examples of suitable ingredient types include:

The examples in the table are ingredient types found in the dietary supplement market. Each ingredient used in products sold in Thailand must meet Thai FDA requirements, and some ingredients require a safety assessment before an application is filed. Some markets permit ingredients such as ashwagandha in dietary supplements under local regulations; study designs follow the rules of the target market.

Clinical study evidence is not just a regulatory document. It is a strategic asset that owners of energy supplement brands can use to create value in several ways.

Premium product positioning

Products backed by clinical study data can be credibly positioned in the premium segment. In a crowded market where energy claims are often questioned, Chalder Fatigue Scale or VAS data measured in the product group compared with a control group give the product’s value proposition a factual basis and set it apart from competitors without such data.

Negotiating with modern trade and e-commerce channels

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

Reducing legal risk and expanding into export markets

Energy claims backed by clinical study evidence reduce the risk that advertising will be considered exaggerated under the Food Act B.E. 2522 (1979). A study designed and reported in line with international practice is also an important part of preparing for export markets, although each country has its own requirements.

Using scientific data in communication

Data actually measured in a clinical study can be used across several communication channels. Any use in advertising must first obtain advertising approval from the Thai FDA as required by law.

1. Dietary supplements sold in Thailand must be approved by the Thai FDA and hold a food serial number (Thai FDA number) before the study starts. For products from international sponsors, VISBIO assesses the legal requirements 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 claims.
3. Every study must be approved by a human research ethics committee before it starts, without exception.

For brands that want to build evidence at every level, VISBIO supports laboratory work such as coenzyme Q10 content analysis by HPLC, vitamin B12 content analysis, antioxidant activity testing and cell-based (in vitro) efficacy testing, through to clinical studies in volunteers. Confirming the content of key ingredients in the product before the study starts ties the clinical results to a verifiable formula. GCP applies to studies in humans, while laboratory work follows the test method of each assay. Planning every level of evidence with a single coordinator keeps the data at each stage consistent and free of gaps. Clinical trial services for other dietary supplements are described on the knee health supplement clinical trial page.

How are energy supplements measured in a clinical study?

Volunteers rate their fatigue and energy levels using standard assessments such as the Chalder Fatigue Scale and a visual analog scale (VAS) at the time points set in the protocol, and the product group is compared with a placebo group, together with adverse event recording throughout the study.

What is the Chalder Fatigue Scale?

It is a 14-item self-rated scale whose validity and reliability have been tested. It measures the severity of fatigue and separates physical from mental fatigue.

What do the coenzyme Q10 and ashwagandha studies tell us about study design?

The coenzyme Q10 study measured the fatigue volunteers perceived after a controlled physical workload, while the ashwagandha study measured stress together with cortisol levels and did not measure fatigue directly. These examples show that endpoints must match the claim to be substantiated from the protocol design stage.

Does a product with a Thai FDA number still need clinical data?

The Thai FDA number for a dietary supplement is based mainly on an assessment of safety and quality. It does not confirm that the product has the stated effect on energy levels or tiredness. If you want to communicate such benefits, clinical data provide supporting evidence, and advertising must still comply with food law.

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

VISBIO designs the study and provides project management and coordination with a network of partner clinical research sites and hospitals. Volunteers are recruited and cared for by the physicians and investigators of the 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 and obtain approval from the relevant authorities where the law requires it. VISBIO does not guarantee study outcomes or regulatory decisions.

If you are interested in a clinical trial for your energy or fatigue supplement, contact VISBIO for a free initial consultation through the following channels:

• Contact form: https://visbio.co.th/en/contact-us/
• LINE Official Account: @visbio
• Email: service@visbio.co.th
• Phone: 098-635-4197 (+66 98 635 4197)
• Timeline: please ask our team directly.

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

• VISBIO’s role: VISBIO designs studies and provides project management and project coordination 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 site responsible for the study.
• Research ethics: Every study in humans starts only after approval by a human research ethics committee and is conducted in line with Good Clinical Practice (GCP). All volunteers give informed consent after receiving complete information.
• Drugs and herbal medicines: Studies must follow the requirements of the Thai Food and Drug Administration (Thai FDA) 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. Chandrasekhar, K., Kapoor, J., & Anishetty, S. (2012). A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults. Indian Journal of Psychological Medicine, 34(3), 255–262. https://doi.org/10.4103/0253-7176.106022
3. Mizuno, K., Tanaka, M., Nozaki, S., Mizuma, H., Ataka, S., Tahara, T., Sugino, T., Shirai, T., Kajimoto, Y., Kuratsune, H., Kajimoto, O., & Watanabe, Y. (2008). Antifatigue effects of coenzyme Q10 during physical fatigue. Nutrition, 24(4), 293–299. https://doi.org/10.1016/j.nut.2007.12.007