search
Back to results

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
Skidmore College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Weight Loss focused on measuring fat oxidation, hunger, resistant starch, whey protein

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 7, 2015
    Last Updated
    September 5, 2018
    Sponsor
    Skidmore College
    search

    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

    We'll reach out to this number within 24 hrs