NCT01976455

Brief Summary

The purpose of this study is to develop a novel, non-invasive method that will provide personalized feedback during dietary interventions as a marker for compliance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

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

September 12, 2013

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

3.1 years

First QC Date

September 12, 2013

Last Update Submit

January 18, 2022

Conditions

Over-eatingObesity

Keywords

obesitycarbon13over-eatingmetabolic chamberroom calorimeter

Outcome Measures

Primary Outcomes (1)

  • Increase in breath Carbon 13 with overconsumption of calories

    A period of positive energy balance following one of negative energy balance increase breath Carbon13.

    11 days

Study Arms (2)

20% calorie depletion

During each 11-day stays the volunteer will have 9 days of calorie depletion (20% one stay and 40% the other).

Other: 20% fewer caloriesOther: 40% fewer calories

40% calorie depletion

During each 11-day stays the volunteer will have 9 days of calorie depletion (20% one stay and 40% the other).

Other: 20% fewer caloriesOther: 40% fewer calories

Interventions

20% fewer caloriesOTHER
20% calorie depletion40% calorie depletion
40% fewer caloriesOTHER
20% calorie depletion40% calorie depletion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men \& Women age 18 to 65 years with a BMI of 25- 40 kg/m2.

You may qualify if:

  • to 65 years old
  • Overweight (BMI 25-40 kg/m2)

You may not qualify if:

  • Metabolic or cardiovascular abnormalities (diabetes, uncontrolled hypertension, etc.)
  • Gastrointestinal disorders
  • Disease that affects macronutrient utilization
  • Medication that affects macronutrient utilization
  • Allergies to foods to be utilized in the study (including but not limited to lactose intolerance/milk allergy)
  • Use of nutritional/sport supplements
  • Pregnant or currently trying to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

MeSH Terms

Conditions

HyperphagiaObesity

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Shanon Casperson, PhD

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

  • James N Roemmich, PhD

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
OTHER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2013

First Posted

November 5, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)