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| Name | Class |
|---|---|
| Glycemic Index Laboratories, Inc | INDUSTRY |
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The present study aims to investigate the effect of a standardized liquid breakfast containing a food grade propionate colon release form on ad libitum eating and appetite perception in healthy overweight humans using a double-blinded, randomized, cross-over study design
To determine, in healthy overweight subjects, the acute effect of a standardized liquid breakfast containing a propionate colon release form compared with placebo on appetite and GI comfort, food intake, serum glucose and insulin, plasma ghrelin, total GLP-1 and serum PYY concentrations, and plasma propionate concentrations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propionate (1 g) | Experimental | Participants will receive 1 g of Ca-propionate in a colon-release form. Volunteers will receive the product on visits 2, 3 and 4. Each of the visits will be separated by > 5 days. Visit 5, the end of study visit, will occur within 5 days of visit 4. |
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| Propionate (3 g) | Experimental | Participants will receive 3 g of Ca-propionate in a colon-release form. Volunteers will receive the product on visits 2, 3 and 4. Each of the visits will be separated by > 5 days. Visit 5, the end of study visit, will occur within 5 days of visit 4. |
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| Placebo | Placebo Comparator | Participants will receive 2.6 g of cellulose in a colon-release form. Volunteers will receive the product on visits 2, 3 and 4. Each of the visits will be separated by > 5 days. Visit 5, the end of study visit, will occur within 5 days of visit 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ca-propionate 1 g | Dietary Supplement | 1 g of Ca-propionate will be mixed in 203 mL of a standardized liquid breakfast |
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| Measure | Description | Time Frame |
|---|---|---|
| Ad-libitum energy intake | Ad-libitum energy intake will be assessed by giving subjects a choice of an excess of individual pizza slices | t=210 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective ratings of appetite and GI comfort | Subjective measurements of motivation to eat and GI physical comfort will be assessed using validated questionnaires, i.e. Visual Analog Scales (VAS). Each of the questions on the VAS is a 100 mm line anchored at each end with opposing statements. Participants mark a vertical line on the line at a point that they felt reflect their feelings at the moment the test was taken. Scores will be assessed by measuring the distance between the intersection of the vertical line with the line and the left end of the line. VAS include a set of questions, such as feelings of fullness, feelings of hunger, prospective food consumption. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Wolever | GI Labs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GI Labs | Toronto | Canada |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Ca-propionate 3 g | Dietary Supplement | 3 g of Ca-propionate will be mixed in 203 mL of a standardized liquid breakfast |
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| Placebo | Dietary Supplement | 2.6 g of cellulose will be mixed in 203 mL of a standardized liquid breakfast |
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| Every 30 minutes during an interval of 6 hours |
| 24 h food intake | Completion of a food diary | Food intake is recorded from the time of the start of the ad-libitum food test until 24 hours later |
| Serum glucose | Serum glucose analysis will be done using either the Vitros 350 Chemistry System or an YSI model 2300/2700 STAT analyser | Every 30 minutes during an interval of 6 hours |
| Plasma insulin | Plasma insulin will be measured using an insulin ELISA Immunoassay kit | Every 30 minutes during an interval of 6 hours |
| Plasma ghrelin | Immunoassay kits will be used to measure plasma ghrelin | Every 30 minutes during an interval of 6 hours |
| Plasma total glucagon-like peptide-1 (GLP-1) | Immunoassay kits will be used for measure plasma total GLP-1 | Every 30 minutes during an interval of 6 hours |
| Plasma peptide YY (PYY) | Immunoassay kits will be used for measure plasma PYY | Every 30 minutes during an interval of 6 hours |
| Plasma propionate | Plasma propionate will be measured using HPLC MS/MS | Every 30 minutes during an interval of 6 hours |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |