A Prospective Study Investigating the Effects of a Novel Weight Management Program

NCT01875354 | Completed DMC

• 1 other identifier: 13-PHX-01-NU-02
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and efficacy of a weight management program composed of dietary supplements and a reduced calorie eating program.

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

• Determine the effect of a novel weight management program on body fat mass over 90 days.

  Evaluate changes in body measurements (weight and BMI; arm, waist, hip, thigh, claf, and ankle circumferences) and body composition (fat mass, fat free mass, % body fat) by Dual Energy X-ray Absorptiometry (DEXA) scanner.

  Days 0 and 90

Secondary Outcomes (8)

• Determine the safety of novel weight management program (CBC, Comp. metabolic, lipid panel, heart rate, blood pressure and adverse events)

  Throughout 1 year

• Evaluate changes in body measurements (weight and BMI; arm, waist, hip, thigh, claf, and ankle circumferences) and body composition (fat mass, fat free mass, % body fat) by Dual Energy X-ray Absorptiometry (DEXA) scanner.

  throughout 1 year

• Determine subjective measurements of hunger and appetite from standardized questionnaires (IWQOL Hunger/Appetite and overall wellbeing)

  Throughout 1 year

• Determine skin carotenoid (Biophotonic Scanner) measurement changes.

  Throughout 1 year

• Evaluate the changes in metabolism and appetite hormone levels from the baseline visit to day 90.

  Days 0 and 90

Study Arms (2)

Placebo and Low Fat Eating Plan

PLACEBO COMPARATOR

Placebo Supplement A Powder Mix Days 1 - 15, (1 packet mixed in water or favorite beverage once a day) Placebo Supplement B Days 1 - 90, (1 capsule taken three times a day with a meal) Placebo Supplement C Days 1 - 90, (2 capsules taken with morning and evening meal) The placebo group will be instructed to consume every day, a low fat standard of care eating plan delivering approximately 1200-1500 Kcals.

Dietary Supplement: Placebo and Low Fat Eating Plan

Dietary Supplements and TR90 Eating Plan

EXPERIMENTAL

Supplement A Powder Mix Days 1 - 15, (1 packet mixed in water or favorite beverage once a day) Supplement B Days 1 - 90, (1 capsule taken three times a day with a meal) Supplement C Days 1 - 90, (2 capsules taken with morning and evening meal) Experimental group will be instructed to consume every day, dietary supplements and a moderate protein eating plan delivering approximately 1200-1500 Kcals.

Dietary Supplement: Dietary Supplements and TR90 Eating Plan

Interventions

Dietary Supplements and TR90 Eating Plan DIETARY_SUPPLEMENT

Supplements to maintain muscle, assist in utilization of body fat, curb appetite, support positive willpower along with TR90 Eating plan. TR90 Eating Plan will consist of approximately 30 g high quality protein along with fruit, vegetables and complex carbohydrates

Dietary Supplements and TR90 Eating Plan

Placebo and Low Fat Eating Plan DIETARY_SUPPLEMENT

Placebo and Low Fat Eating Plan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18-65 years of age at the time of informed consent
• The ability to read, speak and understand the English language in order to complete the required paper informed consent, assessments and diary
• Access to email and to a digital camera or camera phone
• Willing and able to provide written informed consent
• Willing and able to comply with the study restrictions, procedures and assessments and attend regularly scheduled clinic visits
• Willing and able to accommodate being contacted by the study staff for telephone call visits, follow-up contacts, and study visit reminders
• BMI is equal to or greater than 25 and less than or equal to 40 kg/m2
• Use of effective method of contraception by females of childbearing potential 30-days before the screening visit and agree to continue to practice that acceptable method of contraception for the duration of her participation in the study
• A resting normotensive blood pressure, as defined as a systolic blood pressure between 150-90 mmHg and a diastolic blood pressure of between 95-50 mmHg, at screening visit 1(A)
• Willing to fast for at least 8 hours prior to the study procedures being performed that require fasting measurements
• Willing and able to follow eating program and able to consume the study supplied Supplements, Placebos and shakes (which include whey and/or egg protein) on a daily basis. Subjects that are lactose intolerant will be considered ineligible
• Only one member per household eligible to participate in the study

You may not qualify if:

• A subject that has any Axis I Psychiatric disorders according to the DSM-IV criteria that would prevent the subject from being able to comply with study requirements and/or taking anti-psychotic medication
• Diagnosed with insomnia and is chronically using prescribed or OTC insomnia medications
• A self-reported chronic condition that may affect subject safety
• An HbA1c of greater than or equal to 7.0%
• Renal insufficiency as defined by a laboratory Glomerular Filtration Rate of less than 50 mL/min/1.73 m2
• Chronically using glucocorticoid steroids
• Currently pregnant, planning to become pregnant during the course of the study or is breastfeeding
• Use of antihypertensive medication(s) for less than 90 days prior to screening
• Diagnosed with any thyroid disorder or has a clinically significant out of range laboratory value (i.e. TSH, T3 Free, and/or T4 Free) value measured at screening
• Known allergy or intolerance to any of the ingredients contained in the Novel Supplements, placebos or shakes (cow milk proteins)
• Planned surgical procedure during the 365 day course of the study
• Currently participating in another clinical research study or have done so within 30 days prior to the screening visit
• Diagnosis of milk or egg intolerance
• Participating in another weight loss program or using another weight loss product. Subjects may enroll if they are willing to stop the weight loss program they are currently on and/or washout of the product they are using. The appropriate washout will be reviewed with the investigator or medically qualified designee on a case by case basis
• Fasting LDL-C greater than 190 mg/dL or triglycerides greater than 400 mg/dL.

Sponsors & Collaborators

• Pharmanex: lead
• Utah State University: collaborator

Study Sites (1)

Utah State University

Logan, Utah, 84322, United States

Location

MeSH Terms

Conditions

Overweight

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Michael Lefevre, PhD

  Utah State University

  PRINCIPAL INVESTIGATOR

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 11, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

US (1)