NST: Types of Resistant Starch and Their Effect on Appetite

Sponsor

Clinical Nutrition Research Center, Illinois Institute of Technology (Industry)

Overall Status

Completed

CT.gov ID

NCT01125878

Collaborator

Ingredion Incorporated (Industry)

Enrollment

Location

Arms

12.9

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Understanding Resistant Starch on Satiety in Premenopausal Women

Actual Study Start Date :

Sep 2, 2010

Actual Primary Completion Date :

Jul 12, 2011

Actual Study Completion Date :

Sep 29, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Starch Composite B fiber mixture	Dietary Supplement: Starch composite B fiber mixture
Active Comparator: Starch Composite C fiber mixture	Dietary Supplement: Starch composite C fiber mixture
Active Comparator: Starch Composite D fiber mixture	Dietary Supplement: Starch composite D fiber mixture
Placebo Comparator: Placebo Placebo	Dietary Supplement: Placebo placebo

Outcome Measures

Primary Outcome Measures

Subjective and behavioral satiety responses after consumption of the resistant starch composites by visual analog scales and subsequent food intake. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Clinical Nutrition Research Center	Chicago	Illinois	United States	60616

Sponsors and Collaborators

Clinical Nutrition Research Center, Illinois Institute of Technology
Ingredion Incorporated

Investigators

Principal Investigator: Britt Burton-Freeman, PhD, MS, Clinical Nutrition Research Center, Illinois Institute of Technology
Principal Investigator: Indika Edirisinghe, PhD, Clinical Nutrition Research Center, Illinois Institute of Technology