Resistant Starch and Whey Protein on Energy Metabolism
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
waxy maize starch
waxy maize starch and Whey Protein
Resistant Starch
resistant starch and whey protein
Sponsored by

About this trial
This is an interventional other trial for Weight Loss focused on measuring fat oxidation, hunger, resistant starch, 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
waxy maize starch
waxy maize starch and whey protein
resistant starch
resistant starch and whey protein
Arm Description
pancake test meal - waxy maize starch
pancake test meal - waxy maize starch and whey protein
pancake test meal - resistant starch
pancake test meal - resistant starch and whey protein
Outcomes
Primary Outcome Measures
Change in fat oxidation from Baseline to 180 Minutes Postprandial
indirect calorimetry of fuel utilization
Secondary Outcome Measures
Change in gut hormones from Baseline to 180 Minutes Postprandial
gastro-entero-pancreatic hormones
Change in self-reported feelings of hunger, fullness, satiation from Baseline to 180 Minutes Postprandial
visual analog scale of hunger, fullness and satiation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02418429
Brief Title
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
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Skidmore College
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
fat oxidation, hunger, resistant starch, whey protein
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
waxy maize starch
Arm Type
Active Comparator
Arm Description
pancake test meal - waxy maize starch
Arm Title
waxy maize starch and whey protein
Arm Type
Active Comparator
Arm Description
pancake test meal - waxy maize starch and whey protein
Arm Title
resistant starch
Arm Type
Active Comparator
Arm Description
pancake test meal - resistant starch
Arm Title
resistant starch and whey protein
Arm Type
Active Comparator
Arm Description
pancake test meal - resistant starch and whey protein
Intervention Type
Other
Intervention Name(s)
waxy maize starch
Other Intervention Name(s)
WMS
Intervention Description
pancake test meal with waxy maize starch only
Intervention Type
Other
Intervention Name(s)
waxy maize starch and Whey Protein
Other Intervention Name(s)
WMS-WP
Intervention Description
pancake test meal with waxy maize starch and whey protein
Intervention Type
Other
Intervention Name(s)
Resistant Starch
Other Intervention Name(s)
RS
Intervention Description
pancake test meal with resistant starch only
Intervention Type
Other
Intervention Name(s)
resistant starch and whey protein
Other Intervention Name(s)
RS-WP
Intervention Description
pancake test meal with resistant starch and whey protein
Primary Outcome Measure Information:
Title
Change in fat oxidation from Baseline to 180 Minutes Postprandial
Description
indirect calorimetry of fuel utilization
Time Frame
time 0, 60, 120, 180 minutes
Secondary Outcome Measure Information:
Title
Change in gut hormones from Baseline to 180 Minutes Postprandial
Description
gastro-entero-pancreatic hormones
Time Frame
time 0, 60, 120, 180 minutes
Title
Change in self-reported feelings of hunger, fullness, satiation from Baseline to 180 Minutes Postprandial
Description
visual analog scale of hunger, fullness and satiation
Time Frame
time 0, 60, 120, 180 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Arciero, PhD
Organizational Affiliation
Skidmore College
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26514213
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.
Results Reference
derived
Learn more about this trial
Resistant Starch and Whey Protein on Energy Metabolism
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