Weight Loss Clinical Trial
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
| 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 |
| Verified date | September 2018 |
| Source | Skidmore College |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Skidmore College |
| 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 |
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