Types of Resistant Starch and Their Effect on Appetite (NST)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Starch LLC
Information provided by (Responsible Party):
Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier:
NCT01125878
First received: May 11, 2010
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

Investigators are interested in learning how appetite responds to certain types of starch and fiber mixtures. In this research study, subjects will be asked to consume cookie bars containing different types of starch and fiber mixtures, then describe their feelings of hunger, fullness and desire to eat for the 3 hour study period. Subjects will be asked to do this on four separate occasions. Following the 3 hour study period, a deli-style lunch will be served. Investigators want to see how appetite responds to these four different starch and fiber mixtures.


Condition Intervention
Psychological Phenomena and Processes
Dietary Supplement: Placebo
Dietary Supplement: Starch composite B
Dietary Supplement: Starch composite C
Dietary Supplement: Starch composite D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Understanding Resistant Starch on Satiety in Premenopausal Women

Resource links provided by NLM:


Further study details as provided by Institute for Food Safety and Health, United States:

Primary Outcome Measures:
  • Subjective and behavioral satiety responses after consumption of the resistant starch composites by visual analog scales and subsequent food intake. [ Time Frame: 3 hour postprandial study ] [ Designated as safety issue: No ]

    Meals will be provided under fasting conditions and thereafter subjects will record satiety reponses at 30 mins, 60, 90, 120, 150 and 180 on a visual analog scale (VAS). The subject will answer a series of questions on the VAS describing their feelings of hunger, fullness and desire to eat at the above mentioned time points.

    Satiety will also be determined on the quantity of the test lunch meal consumed. This test meal will be served three hours after consumption of the starch composites.



Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Starch Composite B Dietary Supplement: Starch composite B
fiber mixture
Active Comparator: Starch Composite C Dietary Supplement: Starch composite C
fiber mixture
Active Comparator: Starch Composite D Dietary Supplement: Starch composite D
fiber mixture
Placebo Comparator: Placebo Dietary Supplement: Placebo
placebo

Detailed Description:

This study will require one initial screening visit (approximately 1 hour) and four study visits each lasting approximately 4 hours. All visits should be done in 2 months. We are looking for healthy, non-smoking, premenopausal female volunteers older than 18 with no medical history of diabetics, heart, lung, kidney, stomach, or liver disease.

The initial screening visit will determine subject eligibility through height, weight and waist circumference measurements, blood glucose finger prick and eating, health and mood surveys.

If willing and eligible to participate, subjects will have four study visits. All study visits will be scheduled according to each individual subject's menstrual cycle. At each visit subject will be asked to eat the cookie bar and then answer questions about their feelings of hunger, fullness and desire to eat. Subject will continue to answer questions about their feelings of hunger, fullness and desire to eat at specific time points up to 3 hours after eating the yogurt. After 3 hours a lunch meal will be served. The lunch meal consists of typical deli items, such as pasta, rolls, salad, etc. Subject will be allowed to eat as much or as little of the lunch as they'd like.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Premenopausal females
  • 18 years of age and older
  • BMI (body mass index) between 18.5 and 24.9 kg/m2 inclusive
  • No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
  • unrestrained eater (score < 10 on the Three Factor Eating Questionnaire)

Exclusion Criteria:

  • Pregnant and/or lactating or planning for pregnancy
  • Allergies or intolerances to foods consumed in the study
  • Fasting blood glucose > 110 mg/dL. Subjects identified with elevated fasting blood glucose levels will be will be advised to contact their primary care physician for appropriate follow-up care.
  • Taking over the counter fiber supplements or other supplements that may interfere with the study procedures or endpoints
  • Taking prescription medications that may interfere with study procedures or endpoints (medications that affect appetite)
  • Subjects with unusual dietary habits (e.g. pica)
  • Actively losing weight or trying to lose weight (unstable body weight fluctuations of > 5 kg in a 60 day period)
  • Excessive exercisers or trained athletes
  • Addicted to drugs and/or alcohol
  • Medically documented psychiatric or neurological disturbances
  • Smoker (past smoker may be allowed if cessation is > 2 years)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125878

Locations
United States, Illinois
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Institute for Food Safety and Health, United States
National Starch LLC
Investigators
Principal Investigator: Britt Burton-Freeman, PhD, MS Institute for Food Safety and Health, United States
Principal Investigator: Indika Edirisinghe, PhD Institute for Food Safety and Health, United States
  More Information

Publications:
Responsible Party: Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier: NCT01125878     History of Changes
Other Study ID Numbers: NST 2010-027
Study First Received: May 11, 2010
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Institute for Food Safety and Health, United States:
satiety
appetite
fiber
starch
nutrition

ClinicalTrials.gov processed this record on October 21, 2014