NCT02418429

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

April 7, 2015

Last Update Submit

September 5, 2018

Conditions

Weight Loss

Keywords

fat oxidationhungerresistant starchwhey protein

Outcome Measures

Primary Outcomes (1)

  • Change in fat oxidation from Baseline to 180 Minutes Postprandial

    indirect calorimetry of fuel utilization

    time 0, 60, 120, 180 minutes

Secondary Outcomes (2)

  • Change in gut hormones from Baseline to 180 Minutes Postprandial

    time 0, 60, 120, 180 minutes

  • Change in self-reported feelings of hunger, fullness, satiation from Baseline to 180 Minutes Postprandial

    time 0, 60, 120, 180 minutes

Study Arms (4)

waxy maize starch

ACTIVE COMPARATOR

pancake test meal - waxy maize starch

Other: waxy maize starch

waxy maize starch and whey protein

ACTIVE COMPARATOR

pancake test meal - waxy maize starch and whey protein

Other: waxy maize starchOther: waxy maize starch and Whey Protein

resistant starch

ACTIVE COMPARATOR

pancake test meal - resistant starch

Other: Resistant Starch

resistant starch and whey protein

ACTIVE COMPARATOR

pancake test meal - resistant starch and whey protein

Other: Resistant StarchOther: resistant starch and whey protein

Interventions

waxy maize starchOTHER

pancake test meal with waxy maize starch only

Also known as: WMS
waxy maize starchwaxy maize starch and whey protein
waxy maize starch and Whey ProteinOTHER

pancake test meal with waxy maize starch and whey protein

Also known as: WMS-WP
waxy maize starch and whey protein
Resistant StarchOTHER

pancake test meal with resistant starch only

Also known as: RS
resistant starchresistant starch and whey protein
resistant starch and whey proteinOTHER

pancake test meal with resistant starch and whey protein

Also known as: RS-WP
resistant starch and whey protein

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • overweight or lean but otherwise healthy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26514213DERIVED

MeSH Terms

Conditions

Weight Loss

Interventions

Whey ProteinsResistant Starch

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesStarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary FiberDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Paul J Arciero, PhD

    Skidmore College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 16, 2015

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Study Completion

August 1, 2018

Last Updated

September 6, 2018

Record last verified: 2018-09