Clinical trial NCT02418429: Resistant Starch and Whey Protein on Energy Metabolism
Official title: Combined Effects of Dietary Supplementation With Dietary Resistant Starch (RS) and Whey Protein on Resting Energy Expenditure and Blood Sugar and Insulin Responses in Lean and Obese Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: fat oxidation
hunger
resistant starch
whey protein
Lead sponsor: Skidmore College
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Recent evidence shows that dietary supplementation with resistant starch (RS) increases fat catabolism and resting energy expenditure and decreases plasma insulin and glucose responses as well as the gut-derived hormone, glucose-dependent insulinotropic polypeptide (GIP). Consumption of whey protein has also been shown to increase energy expenditure and favorably affect gut hormones. Thus, investigators tested consumption of both RS and whey protein on energy expenditure and gut hormones in lean and obese women and men.

Detailed description: Consumed separately, resistant starch (RS) and whey protein (WP) favorably affect energy metabolism and gut hormones, as well as suppress feelings of hunger. These findings are important because release of certain gut hormones (i.e., GIP) is associated with a lower resting energy expenditure (REE) in healthy humans. Interestingly, a recent study showed that ingestion of RS reduces postprandial GIP and increases postprandial REE and fat utilization in healthy men and therefore may be an effective strategy in weight management. Thus, there is a need to replicate these findings in a healthy cohort of lean and obese women and men.

The purpose of this study was to examine the effects of RS on the number of calories burned after eating a meal, as well as specific hormones that are released from the stomach and intestines following meal ingestion in healthy lean and obese women and men. Investigators used a single ingestion of a meal supplemented with or without the resistant starch and whey protein.

Eligibility criteria: Inclusion Criteria:

* overweight or lean but otherwise healthy

Exclusion Criteria:

* Participants will be excluded if they smoke; have experienced excessive weight loss/gain of \> ±2kg in the previous 2 months; are currently taking medications for cardiovascular or metabolic disease.

Primary outcomes:
measure: Change in fat oxidation from Baseline to 180 Minutes Postprandial
timeFrame: time 0, 60, 120, 180 minutes
Secondary outcomes:
measure: Change in gut hormones from Baseline to 180 Minutes Postprandial
timeFrame: time 0, 60, 120, 180 minutes
measure: Change in self-reported feelings of hunger, fullness, satiation from Baseline to 180 Minutes Postprandial
timeFrame: time 0, 60, 120, 180 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Skidmore College
name: Paul J Arciero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gentile CL, Ward E, Holst JJ, Astrup A, Ormsbee MJ, Connelly S, Arciero PJ. Resistant starch and protein intake enhances fat oxidation and feelings of fullness in lean and overweight/obese women. Nutr J. 2015 Oct 29;14:113. doi: 10.1186/s12937-015-0104-2.