Resistant Starch and Satiety

Healthy Adults Clinical Trial

Official title:

Satiety Response of Resistant Starches

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187875
• Other study ID #: 806M37445
• Status: Completed
• Phase: Phase 0
• First received: June 21, 2010
• Last updated: March 28, 2012
• Start date: September 2009
• Est. completion date: June 2011

Study information

• Verified date: March 2012
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Dietary fiber consumption may contribute to weight regulation by improving satiety. In an earlier study the investigators found that a muffin containing resistant starch was more effective than other fibers in altering satiety. The objective of this study is to determine if 2 resistant starches consumed in muffins alter satiety and whether a mixture of resistant starches is more effective than either alone in enhancing satiety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Healthy men and women

• Age 18-64 years

• Non-smoking

• Not taking medication

• Non dieting (weight stable in prior 3 months)

• BMI 18-27

• English literacy

Exclusion Criteria:

• Do not regularly consume breakfast

• Food allergies to ingredients found in the study products

• BMI <18 or >27

• Diagnosed cardiovascular disease, renal disease, hepatic disease, or diabetes mellitus

• Cancer in previous 5 years

• Any gastrointestinal disease or condition

• Recent bacterial infection (< 3months)

• Recent or concurrent participation in an intervention research study

• History of drug or alcohol abuse in prior 6 months

• Use of lipid lowering, anti-hypertensive, or anti-inflammatory steroid medication

• Eating disorder

• Vegetarians

• People who eat more than approximately 15 grams of fiber per day

• Women who are pregnant or lactating

• Women with irregular menstrual cycles

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Dietary Supplement:
• Placebo- Fiber free control
Dextrin control administered in a muffin treatment.
• Hi-maize resistant starch 9g
9g Hi-maize resistant starch administered in a muffin treatment.
• Novalose 330 resistant starch 9g
9g Novalose 330 resistant starch administered in a muffin treatment.
• 4.5g Hi-maize resistant starch and 4.5g Novalose 330
4.5g Hi-maize and 4.5g Novalose 330 in a muffin treatment.

Locations

Country	Name	City	State
United States	University of Minnesota	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satiety response using visual analogue scales	Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).	0 minutes postprandially	No
Primary	Satiety response using VAS	Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).	15 minutes postprandially	No
Primary	Satiety response using VAS	Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).	30 minutes postprandially	No
Primary	Satiety response using VAS	Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).	45 minutes postprandially	No
Primary	Satiety response using VAS	Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).	60 minutes postprandially	No
Primary	Satiety response using VAS	Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).	90 minutes postprandially	No
Primary	Satiety response using VAS	Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).	120 minutes postprandially	No
Primary	Satiety response using VAS	Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).	180 minutes postprandially	No
Primary	Satiety response using VAS	Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).	240 minutes postprandially	No
Secondary	Ad libitum food intake		240 minutes postprandially and over 24 hours	No
Secondary	Breath hydrogen response		0, 240 minutes	No
Secondary	Gastrointestinal tolerance using visual analogue scales (VAS)	Subjective ratings of bloating, stool consistency, and flatulence on VAS. A stool count was also recorded.	24 hours	No