Types of Resistant Starch and Their Effect on Appetite (NST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01125878|
Recruitment Status : Active, not recruiting
First Posted : May 19, 2010
Last Update Posted : March 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Psychological Phenomena and Processes||Dietary Supplement: Placebo Dietary Supplement: Starch composite B Dietary Supplement: Starch composite C Dietary Supplement: Starch composite D||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Understanding Resistant Starch on Satiety in Premenopausal Women|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
|Active Comparator: Starch Composite B||
Dietary Supplement: Starch composite B
|Active Comparator: Starch Composite C||
Dietary Supplement: Starch composite C
|Active Comparator: Starch Composite D||
Dietary Supplement: Starch composite D
|Placebo Comparator: Placebo||
Dietary Supplement: Placebo
- 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 ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125878
|United States, Illinois|
|Clinical Nutrition Research Center|
|Chicago, Illinois, United States, 60616|
|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|