NCT01272739

Brief Summary

This is a pilot study to determine the safety and efficacy of an investigational product (IHBG-10) on weight loss, and changes in body composition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_2 obesity

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

January 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 6, 2011

Status Verified

January 1, 2011

Enrollment Period

5 months

First QC Date

January 6, 2011

Last Update Submit

October 4, 2011

Conditions

Obesity

Keywords

obesityweight lossweight managementoverweightnutriceutical

Outcome Measures

Primary Outcomes (1)

  • Weight

    12 weeks

Secondary Outcomes (1)

  • Body composition

    12 weeks

Study Arms (2)

Study Group

EXPERIMENTAL

Subjects will take 500 mg of the investigational product 15 minutes prior to the 3 main meals of the day.

Dietary Supplement: IHBG-10

Control Group

PLACEBO COMPARATOR

Subjects will take a placebo 15 minutes prior to the three main meals of the day.

Dietary Supplement: Placebo

Interventions

IHBG-10DIETARY_SUPPLEMENT

500 mg of IHBG-10 taken 15 minutes prior to the three main meals of the day

Also known as: IHBG10
Study Group
PlaceboDIETARY_SUPPLEMENT

Placebo taken 15 minutes prior to the three main meals of the day

Also known as: sugar pill
Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and older
  • Body mass index of 30 or greater
  • Agree to keep diet, exercise and all current health habits stable during participation in the study

You may not qualify if:

  • Women who are pregnant, breastfeeding or planning to become pregnant
  • Prior bariatric surgery
  • Use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month
  • Obesity as a result of a clinically diagnosed endocrine problem
  • Currently taking an anti-psychotic medication
  • History of peptic ulcer disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avera Research Institute

Sioux Falls, South Dakota, 57105, United States

Location

MeSH Terms

Conditions

ObesityWeight LossOverweight

Interventions

Sugars

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Edward Zawada, MD

    Avera McKennan Hospital & University Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2011

First Posted

January 10, 2011

Study Start

February 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 6, 2011

Record last verified: 2011-01

Locations

US(1)