Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02418429
Other study ID # 1307-348
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2013
Est. completion date August 2018

Study information

Verified date September 2018
Source Skidmore College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date August 2018
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
waxy maize starch
pancake test meal with waxy maize starch only
waxy maize starch and Whey Protein
pancake test meal with waxy maize starch and whey protein
Resistant Starch
pancake test meal with resistant starch only
resistant starch and whey protein
pancake test meal with resistant starch and whey protein

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Skidmore College

Outcome

Type Measure Description Time frame Safety issue
Primary Change in fat oxidation from Baseline to 180 Minutes Postprandial indirect calorimetry of fuel utilization time 0, 60, 120, 180 minutes
Secondary Change in gut hormones from Baseline to 180 Minutes Postprandial gastro-entero-pancreatic hormones time 0, 60, 120, 180 minutes
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Active, not recruiting NCT04420936 - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program N/A
Terminated NCT03316105 - Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers N/A
Completed NCT03700736 - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups N/A
Active, not recruiting NCT04353726 - Knowledge-based Dietary Weight Management. N/A
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03377244 - Healthy Body Healthy Souls in the Marshallese Population N/A
Completed NCT02877004 - LLLT for Reducing Waste Circumference and Weight N/A
Active, not recruiting NCT04327141 - Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women N/A
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Recruiting NCT05249465 - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention N/A
Recruiting NCT05942326 - Sleep Goal-focused Online Access to Lifestyle Support N/A
Completed NCT00535600 - Effects of Bariatric Surgery on Insulin
Not yet recruiting NCT03601273 - Bariatric Embolization Trial for the Obese Nonsurgical Phase 1
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT03139760 - POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT02945410 - Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity N/A
Completed NCT02948517 - Time Restricted Feeding for Weight Loss and Cardio-protection N/A
Recruiting NCT02559479 - A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes N/A