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Biologic Assessment of Satiety

This study is currently recruiting participants.
Verified April 2013 by USDA Grand Forks Human Nutrition Research Center
Sponsor:
Information provided by (Responsible Party):
Susan Raatz, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01506297
First received: January 3, 2012
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  Purpose

Subjective measures of satiety are correlated with biologic mechanisms of appetite control.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biologic Assessment of Satiety

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome Measures:
  • Correlation of subjective and objective satiety responses [ Time Frame: measures at -30, -15, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240, 300 minutes ] [ Designated as safety issue: No ]
    Comparison of subjective responses and gut hormone responses of satiety


Secondary Outcome Measures:
  • Repeatability of subjective and objective measures of satiety [ Time Frame: measures at -30, -15, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240, 300 minutes ] [ Designated as safety issue: No ]
    Repeated assessment (3 times) of subjective and objective responses to food intake


Biospecimen Retention:   Samples Without DNA

blood samples


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy men and women

Criteria

Inclusion Criteria:

  • medical history (interview) demonstrating good health
  • non-smoking
  • not taking steroid-based medications
  • not planning to or currently attempting to gain or lose weight
  • being willing to consent to study conditions
  • healthy adults ages 25-45 years
  • body mass index between 18-30 kg/m2.
  • University of North Dakota students may participate but student status is not required.

Exclusion Criteria:

  • diagnosed eating disorders
  • current or planned pregnancy
  • lactation
  • unmanaged hypertension (systolic >160 mmHg or diastolic > 100mmHg) and/or other cardiovascular, pulmonary, skeletal and metabolic diseases
  • taking medications known to affect appetite, body composition, weight, or food intake
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506297

Locations
United States, North Dakota
USDA Human Nutrition Research Center Recruiting
Grand Forks, North Dakota, United States, 58203
Contact: Susan K Raatz, PhD, RD     701-795-8294     susan.raatz@ars.usda.gov    
Principal Investigator: Susan K Raatz, PhD            
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
Principal Investigator: Susan K Raatz, PhD USDA GFHNRC
  More Information

No publications provided

Responsible Party: Susan Raatz, PhD, RD, Research Nutritionist, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01506297     History of Changes
Other Study ID Numbers: GFHNRC504
Study First Received: January 3, 2012
Last Updated: April 1, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by USDA Grand Forks Human Nutrition Research Center:
obesity
satiety
body weight management

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013