Effect of Herbal Compositions on Body Weight, Body Composition and Metabolic Health in Overweight Subjects

NCT07083947 | Active Not Recruiting

• 1 other identifier: APX/OW/CL24212/25
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The Purpose of the study is to evaluate the efficacy of herbal composition CL19183 and CL24212 on body weight, body composition and metabolic health in overweight subjects.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Change from baseline to the end of the study period in Body weight

  The subject's body weight is measured using a digital weighing scale. An improvement is indicated when the body weight falls within the normal range based on the subject's demographic characteristics.

  Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 & Week 16

Secondary Outcomes (14)

• Change from baseline to the end of the study period in Body mass index (BMI)

  Screening, Week 0 (Baseline),Week 2, Week 4, Week 8, Week 12 & Week 16

• Change from baseline to the end of the study period in Body composition using DEXA (including fat and lean mass)

  Week 0 (Baseline), Week 8& Week 16

• Change from baseline to the end of the study period in Waist (WC)

  Week 0 (Baseline),Week 2, Week 4,Week 8,Week 12,Week 16

• Change from baseline to the end of the study period in Hip circumference (HC)

  Week 0 (Baseline),Week 2, Week 4,Week 8,Week 12,Week 16

• Change from baseline to the end of the study period in Waist to hip ratio (WHR)

  Week 0(Baseline), Week 2, Week 4, Week 8, Week 12& Week 16

Study Arms (3)

Placebo

PLACEBO COMPARATOR

One capsule taken orally each morning after breakfast with water for 16 weeks

Other: Placebo

CL19183

EXPERIMENTAL

One capsule taken orally each morning after breakfast with water for 16 weeks

Dietary Supplement: CL19183

CL24212

EXPERIMENTAL

One capsule taken orally each morning after breakfast with water for 16 weeks

Dietary Supplement: CL24212

Interventions

CL19183 DIETARY_SUPPLEMENT

One capsule taken orally each morning after breakfast with water for 16 weeks

CL19183

CL24212 DIETARY_SUPPLEMENT

One capsule taken orally each morning after breakfast with water for 16 weeks

CL24212

Placebo OTHER

One capsule taken orally each morning after breakfast with water for 16 weeks

Placebo

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy male and female subjects aged between 25-55 years with body mass index (BMI) of 25-29.9 kg/m2.
• \. Subjects with sedentary lifestyle, no regular athletic or sports activities. 3. Subjects willing to participate in walking-exercise (5 days a week, 30 min per day) over study duration.
• \. Subjects with normal thyroid hormone profile. 5. Subjects agreed to consume recommended standard diet. 6. Subjects who are willing to abstain from alcohol, coffee, tea, cola, energy drinks \& chocolate for at least 24 hrs. prior to visits and final visit.
• \. Subjects who are non-smokers. 8. Subject agrees to maintain diet tracker. 9. Subject considered generally healthy as per health history and routine clinical investigations during screening.
• \. Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or double-barrier and have a negative pregnancy test at the screening visit.
• \. Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.

You may not qualify if:

• \. Subjects who were taking medications which affect the metabolic rate (e.g. antidepressants, beta-blockers, hormones, etc.).
• \. Subjects on weight loss practices, usage of weight reduction supplements/nutrition products will be excluded.
• \. Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
• \. Subjects participated in any weight loss programs within 3 months. 5. Subjects who are diabetic and/or hypertensive. 6. Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies.
• \. Subjects taking medications for or suffering from a medical condition that could impact results related to metabolism (e.g., thyroid disorders, diabetes, mental disorders such as anxiety or depression, heart disease, arthritis, cancer).
• \. Subjects with HIV Positive. 9. Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study.
• \. Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
• \. Any other condition that, in the opinion of the investigator, would adversely affect the subject's ability to complete the study or its measures.
• \. Use of nutritional supplements (e.g., creatine, protein drinks, amino acids, or vitamins) or ergogenic aids and caffeinated and not caffeinated thermogenics within 30 days prior to the study.
• \. Subjects who are participated or currently participating in another clinical trial within 30 days prior to screening.

Sponsors & Collaborators

• ApexCPG LLC: lead

Study Sites (1)

Swaroop Rani Hospital, Motilal Nehru Medical College

Allahābād, Uttar Pradesh, 211002, India

Location

Related Publications (3)

• Hall KD, Guo J. Obesity Energetics: Body Weight Regulation and the Effects of Diet Composition. Gastroenterology. 2017 May;152(7):1718-1727.e3. doi: 10.1053/j.gastro.2017.01.052. Epub 2017 Feb 11.

  PMID: 28193517 BACKGROUND

• Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29.

  PMID: 24880830 BACKGROUND

• Semlitsch T, Stigler FL, Jeitler K, Horvath K, Siebenhofer A. Management of overweight and obesity in primary care-A systematic overview of international evidence-based guidelines. Obes Rev. 2019 Sep;20(9):1218-1230. doi: 10.1111/obr.12889. Epub 2019 Jul 8.

  PMID: 31286668 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 24, 2025
• Study Start: July 16, 2025
• Primary Completion: January 25, 2026
• Study Completion: January 25, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)