Types of Resistant Starch and Their Effect on Appetite

NCT01125878 | Completed

• 1 other identifier: NST 2010-027
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Phenomena and Processes

Keywords

satiety; appetite; fiber; starch; nutrition

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Starch Composite B

ACTIVE COMPARATOR

fiber mixture

Dietary Supplement: Starch composite B

Starch Composite C

ACTIVE COMPARATOR

fiber mixture

Dietary Supplement: Starch composite C

Starch Composite D

ACTIVE COMPARATOR

fiber mixture

Dietary Supplement: Starch composite D

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

placebo

Placebo

Starch composite B DIETARY_SUPPLEMENT

fiber mixture

Starch Composite B

Starch composite C DIETARY_SUPPLEMENT

fiber mixture

Starch Composite C

Starch composite D DIETARY_SUPPLEMENT

fiber mixture

Starch Composite D

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Premenopausal females
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• Ingredion Incorporated: collaborator

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Related Publications (2)

• 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.

  PMID: 12712245 BACKGROUND

• 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.

  PMID: 16155268 BACKGROUND

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 19, 2010
• Study Start: September 2, 2010
• Primary Completion: July 12, 2011
• Study Completion: September 29, 2011
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)