NCT01423019

Brief Summary

The purpose of this study is to determine whether subjects taking a supplement designed to increase metabolic rate will have a positive effect on body composition (fat mass, muscle mass, and bone density.)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 25, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 23, 2012

Status Verified

January 1, 2012

Enrollment Period

3 months

First QC Date

July 5, 2011

Last Update Submit

January 20, 2012

Conditions

Weight Loss

Keywords

Weight LossBody CompositionFat Free MassBone Mineral DensityAdipose TissueDual-Energy X-Ray AbsorptiometryBody FatEating and appetite controlBasal Metabolic Rate

Outcome Measures

Primary Outcomes (1)

  • Body Composition (fat, fat-free mass and bone mineral density) as measured by Dual Energy X-ray Absorptiometry (DXA)

    This study goes beyond assessing changes in scale weight and BMI. DXA is used to assess changes in body composition (lean, fat and bone) associated with the weight loss interventions.

    0 and 60 days

Secondary Outcomes (14)

  • 43-item blood chemistry panel

    0 and 60 days

  • Change from Baseline in Systolic and Diastolic Blood Pressure at 30 days

    0 and 30 days

  • Change from Baseline in Resting Heart Rate at 30 days

    0 and 30 days

  • Change from midpoint of study in Resting Heart Rate at 60 days

    30 and 60 days

  • Change from Baseline in Systolic and Diastolic Blood Pressure at 60 days

    0 and 60 days

  • +9 more secondary outcomes

Study Arms (3)

Advantra Z

ACTIVE COMPARATOR

Proprietary ingredient for: stimulating thermogenesis, reducing weight, increasing lean muscle mass to total body mass, improving athletic performance, and suppressing appetite

Dietary Supplement: Advantra Z

Advantra Z + Naringin + Hesperiden

ACTIVE COMPARATOR
Dietary Supplement: Advantra Z + Naringin + Hesperiden

Sugar pill

PLACEBO COMPARATOR

Capsule contains inert ingredient.

Other: Sugar pill

Interventions

Advantra ZDIETARY_SUPPLEMENT

Two capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine.

Also known as: p-synephrine
Advantra Z
Advantra Z + Naringin + HesperidenDIETARY_SUPPLEMENT

Two capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine, 600 mg naringin, and 100 mg hesperiden.

Also known as: Naringin, Hesperiden
Advantra Z + Naringin + Hesperiden
Sugar pillOTHER

Two capsules containing inert ingredients are taken twice daily, 20-30 minutes before breakfast and evening meals.

Also known as: Placebo
Sugar pill

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must ensure with medical provider that there are no medical conditions that would preclude participation
  • Must be able to swallow capsules
  • Must be age 21 or above

You may not qualify if:

  • Pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Health Technologies, Inc.

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

  • Stohs SJ, Preuss HG, Keith SC, Keith PL, Miller H, Kaats GR. Effects of p-synephrine alone and in combination with selected bioflavonoids on resting metabolism, blood pressure, heart rate and self-reported mood changes. Int J Med Sci. 2011 Apr 28;8(4):295-301. doi: 10.7150/ijms.8.295.

    PMID: 21537493BACKGROUND

MeSH Terms

Conditions

Weight Loss

Interventions

naringinSugars

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Gilbert R Kaats, PhD FACN

    Integrative Health Technologies, Inc.

    PRINCIPAL INVESTIGATOR

  • Harry G Preuss, MD MACN

    Georgetown University Medical Center, Departments of Biochemistry, Medicine and Pathology

    STUDY CHAIR

  • Sidney J Stohs, PhD

    Dean Emeritus, Creighton University Health Sciences Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Gilbert R. Kaats, PhD

Study Record Dates

First Submitted

July 5, 2011

First Posted

August 25, 2011

Study Start

October 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 23, 2012

Record last verified: 2012-01

Locations

US(1)