Resistant Starch and Satiety

University of Minnesota (UMN)

Status and phase: Completed; Early Phase 1

Conditions: Healthy Adults

Treatments: Dietary Supplement: Placebo- Fiber free control; Dietary Supplement: Hi-maize resistant starch 9g; Dietary Supplement: 4.5g Hi-maize resistant starch and 4.5g Novalose 330; Dietary Supplement: Novalose 330 resistant starch 9g

Study type: Interventional

Funder types: Other

Identifiers

NCT01187875

806M37445

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

20 participants in 4 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Dextrin Control

Treatment:

Dietary Supplement: Placebo- Fiber free control

Hi-maize resistant starch 9g

Experimental group

Description:

Hi-maize resistant starch 9g

Treatment:

Dietary Supplement: Hi-maize resistant starch 9g

Novalose 330 resistant starch 9g

Experimental group

Description:

Novalose 330 resistant starch 9g

Treatment:

Dietary Supplement: Novalose 330 resistant starch 9g

4.5g Hi-maize and 4.5g Novalose 330

Experimental group

Description:

4.5g Hi-maize and 4.5g Novalose 330

Treatment:

Dietary Supplement: 4.5g Hi-maize resistant starch and 4.5g Novalose 330