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

Understanding Resistant Starch on Satiety in Premenopausal Women

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.

Study Overview

• Status: Completed
• Conditions: Psychological Phenomena and Processes
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Starch composite B; Dietary supplement: Starch composite C; Dietary supplement: Starch composite D

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Clinical Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective and behavioral satiety responses after consumption of the resistant starch composites by visual analog scales and subsequent food intake.	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.	3 hour postprandial study

Collaborators and Investigators

• Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology
• Collaborators: Ingredion Incorporated
• Investigators: Principal Investigator: Britt Burton-Freeman, PhD, MS, Clinical Nutrition Research Center, Illinois Institute of Technology

Publications and helpful links

General Publications

• Robertson MD, Currie JM, Morgan LM, Jewell DP, Frayn KN. Prior short-term consumption of resistant starch enhances postprandial insulin sensitivity in healthy subjects. Diabetologia. 2003 May;46(5):659-65. doi: 10.1007/s00125-003-1081-0. Epub 2003 Apr 24.
• Robertson MD, Bickerton AS, Dennis AL, Vidal H, Frayn KN. Insulin-sensitizing effects of dietary resistant starch and effects on skeletal muscle and adipose tissue metabolism. Am J Clin Nutr. 2005 Sep;82(3):559-67. doi: 10.1093/ajcn.82.3.559.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2010
• Primary Completion (Actual): July 12, 2011
• Study Completion (Actual): September 29, 2011

Study Registration Dates

• First Submitted: May 11, 2010
• First Submitted That Met QC Criteria: May 18, 2010
• First Posted (Estimate): May 19, 2010

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: nutrition; appetite; satiety; fiber; starch
• Other Study ID Numbers: NST 2010-027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO