NCT01773356

Brief Summary

The objective of this study is to test the effect of dihydrocapsiate on energy expenditure in women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable 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

Study Start

First participant enrolled

January 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

3.2 years

First QC Date

January 15, 2013

Last Update Submit

September 24, 2015

Conditions

Obesity

Keywords

ObesityBody WeightBody CompositionMetabolismResting Energy Expenditure

Outcome Measures

Primary Outcomes (1)

  • Resting Energy Expenditure

    Change from Baseline at 12 weeks

Secondary Outcomes (2)

  • Thermic effect of feeding

    Change from baseline at 12 weeks

  • Body Composition

    Change from baseline at 12 weeks

Study Arms (2)

Placebo 0 mg/d

PLACEBO COMPARATOR

0 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers

Dietary Supplement: Dihydrocapsiate

Dihydrocapsiate 9 mg/d

ACTIVE COMPARATOR

9 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers

Dietary Supplement: Dihydrocapsiate

Interventions

DihydrocapsiateDIETARY_SUPPLEMENT

Kellogg's ready to eat cereal, cereal bars, and crackers will contain dihyrocapsiate or placebo. Daily consumption of dihydrocapsiate is 9mg/d or 0mg/d.

Also known as: Natural substances present in sweet chili peppers
Dihydrocapsiate 9 mg/dPlacebo 0 mg/d

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI: 18.5-34.5 kg/m2
  • Good general health
  • Low to mild physical activity
  • Willing to maintain habitual diet and physical activity patterns throughout the study period
  • Premenopausal and cycling regularly or using oral contraceptives
  • Willing to attend study visits only during the follicular phase or bleed phase of their menstrual cycle
  • Understands study procedures and signs forms providing informed consent to participate in the study
  • Have spoken and written English literacy

You may not qualify if:

  • Diabetes mellitus or any conditions that might affect energy metabolism
  • Weight change ±2 kg over previous three months
  • Known sensitivity or allergy to ingredients of the study products
  • Non-breakfast eater
  • Recent use of antibiotics
  • History of smoking during the six months prior to study
  • Recent signs or symptoms of infection, including cold or flu-like symptoms
  • Concurrent or recent intervention study participation
  • Instability in breathing patterns or energy expenditure measures
  • History of drug or alcohol abuse
  • Lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use
  • Weight loss medication
  • Pregnant or lactating
  • Unwilling to be randomized to any experimental group and unable to meet all requirements of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Georgia, Department of Kinesiology

Athens, Georgia, 30602-6554, United States

Location

MeSH Terms

Conditions

ObesityBody Weight

Interventions

capsiate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ellen M Evans, Ph.D.

    University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Ellen Evans

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 23, 2013

Study Start

January 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

US(1)