Resistant Starch and Whey Protein on Energy Metabolism

Study Overview
=================
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.

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

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Other: waxy maize starch
* Other: waxy maize starch and Whey Protein
* Other: Resistant Starch
* Other: resistant starch and whey protein


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: waxy maize starch<br>pancake test meal - waxy maize starch | Other: waxy maize starch<br>* pancake test meal with waxy maize starch only<br>* Other names: WMS;|
| Active Comparator: waxy maize starch and whey protein<br>pancake test meal - waxy maize starch and whey protein | Other: waxy maize starch<br>* pancake test meal with waxy maize starch only<br>* Other names: WMS;Other: waxy maize starch and Whey Protein<br>* pancake test meal with waxy maize starch and whey protein<br>* Other names: WMS-WP;|
| Active Comparator: resistant starch<br>pancake test meal - resistant starch | Other: Resistant Starch<br>* pancake test meal with resistant starch only<br>* Other names: RS;|
| Active Comparator: resistant starch and whey protein<br>pancake test meal - resistant starch and whey protein | Other: Resistant Starch<br>* pancake test meal with resistant starch only<br>* Other names: RS;Other: resistant starch and whey protein<br>* pancake test meal with resistant starch and whey protein<br>* 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 | 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 | 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 | visual analog scale of hunger, fullness and satiation | time 0, 60, 120, 180 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fat oxidation, hunger, resistant starch, whey protein