Influence of a Novel Food-Grade Formulation of Red Chili Extract (Capsicum annum) on Overweight Subjects: Randomized, Double-Blinded, Placebo-Controlled Study

Abstract

Capsaicinoids from pungent red chilies (Capsicum annum and Capsicum frutescens) have received significant attention as a natural supplement for the management of obesity. However, the consumption of chili extract at physiologically relevant dosage of capsaicinoids is a challenge owing to its pungency and gastrointestinal discomforts. The present study reports the systemic absorption, safety and influence of a novel, food-grade, and sustained-release formulation of capsaicinoids-rich red chili extract using fenugreek dietary fiber (Capsifen^®). Twenty-four healthy overweight subjects were randomized into placebo (n = 12) and Capsifen (n = 12) groups and supplemented with 200 mg × 1/day of Capsifen (4 mg capsaicinoids/day) for 28 days. Influence of Capsifen on eating behavior and appetite was followed by Three-Factor Eating Questionnaire (TFEQ) and Council of Nutrition Appetite Questionnaire (CNAQ), respectively. Consumption of Capsifen did not reveal any adverse events or deviations in hematology and biochemical parameters related to safety. However, a significant decrease in body weight (2.1%), w/h ratio (4%) and body mass index (BMI) (2.2%) were observed among Capsifen group when compared to placebo. The TFEQ and appetite analysis revealed a significant improvement in uncontrolled eating and reduction in appetite among Capsifen subjects. The UPLC-ESI-MS/MS analysis confirmed the absorption of capsaicinoids from CAP supplementation. The study further demonstrated the safety and tolerability of Capsifen at the investigational dosage. Thus, the significant reduction in anthropometric parameters such as body weight, w/h ratio, and BMI along with the improvement in eating behaviour as well as appetite, indicated the potential body weight management effect of Capsifen.

KEYWORDS:

• Appetite
• body mass index
• bioavailability
• capsicum
• capsaicinoids
• CNAQ
• obesity
• TFEQ

Acknowledgments

The authors are grateful to M/s Akay Natural Ingredients, Cochin, India, for the CAP samples. Authors also thank Mr. Renny Mammen and Ms. Johannah for their support in the coordination of the study and Mr. Abhilash MB for Mass spectrometry analysis of the serum samples.

Declaration of interest

The authors declare no conflicts of interest. The authors alone are responsible for the content and writing of the article. “CAP” is a proprietary formulation of Akay Natural Ingredients Pvt. Ltd., Cochin, India, trademarked as Capsifen^®.

Author’s contribution

RM belongs to a non-profitable academic institution who performed the statistical analysis of the data and interpreted the results. AJ developed the formulation, FJ and SDS monitored the study, gathered the data from clinical research organization and prepared the manuscript. BM and KIM conceived the idea, developed the protocol and edited the manuscript.

Funding

The study was financially supported by M/s Akay Natural Ingredients Pvt. Ltd., India as a part of the research program (Reg. No. AK/R&D/NPP-02/2018) for the development of “Spiceuticals^®” – the nutraceutical ingredients from spices. The funders has developed the formulation, conceived the idea, developed the protocol and prepared the manuscript; but had no role in the execution of the study, sample collection, analysis and interpretation of data.

Additional information

Notes on contributors

Jestin V. Thomas, MSc

Jestin V Thomas, MSc, Director, Leads Clinical Research & Bioservices Pvt Ltd. Interested in clinical research.

Syam Das, PhD Sivadasan

Syam Das S, PhD, Akay Natural Ingredients Pvt Ltd, India. Interested in research in nutraceuticals.

Balu Maliakel, PhD

Balu Maliakel, PhD, Managing Director, Akay Natural Ingredients Pvt Ltd, India. An organic chemist, Interested in natural biomolecules.

Ratheesh Mohan, PhD

Ratheesh Mohan, PhD, Department of Biochemistry, St. Thomas College Pala, India. Interested in nutraceutical formulations and studies in bioactive compounds.

Krishnakumar I. M.

Krishnakumar IM, PhD, Chief Research Officer, Akay Natural Ingredients Pvt Ltd, India. A Bio-organic chemist interested in natural bioactive molecules, delivery forms and pharmacological effects.