Resistant Starch and Whey Protein on Energy Metabolism

September 5, 2018 updated by: Skidmore College

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: waxy maize starch
pancake test meal - waxy maize starch
Other: waxy maize starch
pancake test meal with waxy maize starch only
Other Names:
  • WMS
Active Comparator: waxy maize starch and whey protein
pancake test meal - waxy maize starch and whey protein
Other: waxy maize starch
pancake test meal with waxy maize starch only
Other Names:
  • WMS
Other: waxy maize starch and Whey Protein
pancake test meal with waxy maize starch and whey protein
Other Names:
  • WMS-WP
Active Comparator: resistant starch
pancake test meal - resistant starch
Other: Resistant Starch
pancake test meal with resistant starch only
Other Names:
  • RS
Active Comparator: resistant starch and whey protein
pancake test meal - resistant starch and whey protein
Other: Resistant Starch
pancake test meal with resistant starch only
Other Names:
  • RS
Other: resistant starch and whey protein
pancake test meal with resistant starch and whey protein
Other Names:
  • RS-WP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fat oxidation from Baseline to 180 Minutes Postprandial
Time Frame: time 0, 60, 120, 180 minutes
indirect calorimetry of fuel utilization
time 0, 60, 120, 180 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gut hormones from Baseline to 180 Minutes Postprandial
Time Frame: time 0, 60, 120, 180 minutes
gastro-entero-pancreatic hormones
time 0, 60, 120, 180 minutes
Change in self-reported feelings of hunger, fullness, satiation from Baseline to 180 Minutes Postprandial
Time Frame: time 0, 60, 120, 180 minutes
visual analog scale of hunger, fullness and satiation
time 0, 60, 120, 180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skidmore College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 12, 2015

First Posted (Estimate)

April 16, 2015

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1307-348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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