Clinical trial · Interventional
Evaluation of a Supplement for Weight Management in Obese and Overweight Individuals
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trial is to examine the effects of a novel, orally consumed dietary supplement (composed of naturally occurring components) on weight management and metabolic rate in individuals who are overweight or obese following a 12-week supplementation period. The investigator's primary outcome will be changes in body composition measured via dual energy x-ray absorptiometry (DXA), which will measure changes in fat and lean mass during the supplementation period. Another primary objective will be to determine whether or not the body mass index (BMI) changes during the supplementation period. A secondary objective of the study is to determine whether anthropometric measurements (waist-to-hip ratio) is altered following the supplementation period. Another secondary objective of this study is to determine whether metabolic rate (as measured in VO2 consumption at rest and during exercise) is changed following the supplementation period. Another secondary objective is to determine whether blood pressure (systolic and diastolic pressure, measured in mm Hg) and physical function (measured via VO2peak in mL/min/kg-1 and leg strength in kilograms) change when the supplement is administered over a 12-week period. Another secondary objective will determine how glycemic control, blood markers of inflammation and cholesterol are affected by this intervention.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Men | Multiple Endocrine Neoplasia | ALIAS | 0.90 |
| Overweight and Obesity | — | UNRESOLVED | — |
| Women | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Supplement | Dietary Supplement | — | UNRESOLVED |
| Placebo supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active Supplement
- description
- Participants will be allocated in a randomized, double-masked manner to receive a multi-faceted supplement for the 12-week duration of the study
- interventionNames
- Dietary Supplement: Active Supplement
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants will be allocated in a randomized, double-masked manner to receive a placebo supplement (the placebo will be made of microcrystalline cellulose, and will be matched in size, appearance, taste and caloric value) for the 12-week duration of the study
- interventionNames
- Dietary Supplement: Placebo supplement
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female * overweight (BMI 25 - 29.9 kg/m2) or obese (BMI \> 30 kg/m2) * Physically inactive (\< 1 hour of formal exercise/week) Exclusion Criteria: Participants will be excluded and/or released from the study if they meet any one of the following: * Smoking * Use of assistive walking devices (e.g., cane, or walker) * Chronic use of analgesic or anti-inflammatory drugs * Diabetes mellitus (more than one anti-diabetic drug) * Cardiovascular disease (recent myocardial infarction (\< 6 months) and/or hypertension requiring more than 2 medications) * Congestive heart failure requiring more than one medication for control * Renal disease (creatinine \> 140) * Previous stroke * Active musculoskeletal injuries and/or severe osteoarthritis * Significant weight loss in the 3-month period prior to the study * Vegan diet * Muscular dystrophy * Severe peripheral neuropathy * Severe osteoporosis * Use medications known to affect protein metabolism (i.e. corticosteroids) * Inability to consent * Chronic obstructive pulmonary disease, and asthma requiring more than two medications.
References
Publications (7)
- BACKGROUNDGodard MP, Johnson BA, Richmond SR. Body composition and hormonal adaptations associated with forskolin consumption in overweight and obese men. Obes Res. 2005 Aug;13(8):1335-43. doi: 10.1038/oby.2005.162. PMID 16129715
- BACKGROUNDBailey SJ, Winyard P, Vanhatalo A, Blackwell JR, Dimenna FJ, Wilkerson DP, Tarr J, Benjamin N, Jones AM. Dietary nitrate supplementation reduces the O2 cost of low-intensity exercise and enhances tolerance to high-intensity exercise in humans. J Appl Physiol (1985). 2009 Oct;107(4):1144-55. doi: 10.1152/japplphysiol.00722.2009. Epub 2009 Aug 6. PMID 19661447
- BACKGROUNDCordero MD, Cano-Garcia FJ, Alcocer-Gomez E, De Miguel M, Sanchez-Alcazar JA. Oxidative stress correlates with headache symptoms in fibromyalgia: coenzyme Q(1)(0) effect on clinical improvement. PLoS One. 2012;7(4):e35677. doi: 10.1371/journal.pone.0035677. Epub 2012 Apr 19. PMID 22532869
- BACKGROUNDMaki KC, Reeves MS, Farmer M, Yasunaga K, Matsuo N, Katsuragi Y, Komikado M, Tokimitsu I, Wilder D, Jones F, Blumberg JB, Cartwright Y. Green tea catechin consumption enhances exercise-induced abdominal fat loss in overweight and obese adults. J Nutr. 2009 Feb;139(2):264-70. doi: 10.3945/jn.108.098293. Epub 2008 Dec 11. PMID 19074207
- BACKGROUNDRasool AH, Yuen KH, Yusoff K, Wong AR, Rahman AR. Dose dependent elevation of plasma tocotrienol levels and its effect on arterial compliance, plasma total antioxidant status, and lipid profile in healthy humans supplemented with tocotrienol rich vitamin E. J Nutr Sci Vitaminol (Tokyo). 2006 Dec;52(6):473-8. doi: 10.3177/jnsv.52.473. PMID 17330512
- BACKGROUNDThom E. The effect of chlorogenic acid enriched coffee on glucose absorption in healthy volunteers and its effect on body mass when used long-term in overweight and obese people. J Int Med Res. 2007 Nov-Dec;35(6):900-8. doi: 10.1177/147323000703500620. PMID 18035001