Evaluation of a Supplement for Weight Management in Obese and Overweight Individuals

NCT03812211 | Completed DMC

• 1 other identifier: 5754
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Overweight and Obesity; Men; Women

Outcome Measures

Primary Outcomes (2)

• Body composition

  Fat free mass and fat mass measured via DXA

  12 weeks

• Body mass index

  Measure of body fat based on height and weight that applies to adult men and women

  12 weeks

Secondary Outcomes (9)

• Blood pressure

  12 weeks

• Muscle strength

  12 weeks

• Aerobic fitness

  12 weeks

• Fuel source utilization

  12 weeks

• Hemaglobin A1C in mmol/mol

  12 weeks

Study Arms (2)

Active Supplement

ACTIVE COMPARATOR

Participants will be allocated in a randomized, double-masked manner to receive a multi-faceted supplement for the 12-week duration of the study

Dietary Supplement: Active Supplement

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo supplement

Interventions

Active Supplement DIETARY_SUPPLEMENT

Examine the effects of a multi-faceted supplement comprised of vitamins, minerals and naturally occurring and plant extracts approved for consumption of in overweight/obese men and women

Active Supplement

Placebo supplement DIETARY_SUPPLEMENT

Examine the effects of a placebo supplement in overweight/obese men and women, compare to the active supplement

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female
• overweight (BMI 25 - 29.9 kg/m2) or obese (BMI \> 30 kg/m2)
• Physically inactive (\< 1 hour of formal exercise/week)

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University Medical Center

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (7)

• Godard 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 BACKGROUND

• Bailey 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 BACKGROUND

• Cordero 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 BACKGROUND

• Maki 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 BACKGROUND

• Rasool 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 BACKGROUND

• Thom 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 BACKGROUND

• Zembron-Lacny A, Slowinska-Lisowska M, Szygula Z, Witkowski K, Stefaniak T, Dziubek W. Assessment of the antioxidant effectiveness of alpha-lipoic acid in healthy men exposed to muscle-damaging exercise. J Physiol Pharmacol. 2009 Jun;60(2):139-43.

  PMID: 19617657 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor, Director of Neuromuscular and Neurometabolic Clinic

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: March 1, 2019
• Primary Completion: April 24, 2020
• Study Completion: December 2, 2022
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)