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Completed

NCT Number: NCT02418429

Resistant Starch and Whey Protein on Energy Metabolism

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

waxy maize starch

Other

pancake test meal with waxy maize starch only

Other names: WMS

waxy maize starch and Whey Protein

Other

pancake test meal with waxy maize starch and whey protein

Other names: WMS-WP

Resistant starch

Other

pancake test meal with resistant starch only

Other names: RS

resistant starch and whey protein

Other

pancake test meal with resistant starch and whey protein

Other names: RS-WP

Primary outcomes

  1. Change in fat oxidation from Baseline to 180 Minutes Postprandial

    Time frame: time 0, 60, 120, 180 minutes

    indirect calorimetry of fuel utilization

Secondary outcomes

  1. Change in gut hormones from Baseline to 180 Minutes Postprandial

    Time frame: time 0, 60, 120, 180 minutes

    gastro-entero-pancreatic hormones

  2. 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

Sponsors and collaborators

Lead sponsor

Skidmore College

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2018
First posted
Apr 16, 2015
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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