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| Name | Class |
|---|---|
| Glycemic Index Laboratories, Inc | INDUSTRY |
The objective of this study is to determine the effect of a high protein, high fiber supplement pre-load on energy intake at a subsequent meal compared to a low fiber, high carbohydrate Control product in healthy overweight and obese subjects. The investigators hypothesize the high protein, high fiber pre-load will result in reduced energy intake at a subsequent meal compared to low protein, low fiber.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high protein, high fiber | Experimental | Participants receive a high protein, high fiber dietary supplement pre-load |
|
| Low protein, low fiber | Placebo Comparator | Participants receive a low protein, low fiber isocaloric pre-load |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High protein, high fiber dietary supplement | Dietary Supplement |
| ||
| Low protein, low fiber comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Energy intake (total kilocalories) at meal subsequent to intervention pre-load | Participants will consume an ad-libitum pizza meal for 30 minutes, 30 minutes following ingestion of the pre-load intervention. At the end of the 30 minute pizza meal, total caloric intake will be recorded. | 1 hour post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Appetite Questionnaire on scale of 0-100 | A standard VAS Appetite questionnaire will be completed by subjects before pre-load intervention, and at indicated time intervals. The 4 questions assess hunger, fullness, desire to eat, and prospective consumption. 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Wolever, PhD,DM(Oxon) | Glycemic Index Laboratories, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glycemic Index Laboratories, Inc. | Toronto | Ontario | M5C 2N8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29955731 | Derived | Sharafi M, Alamdari N, Wilson M, Leidy HJ, Glynn EL. Effect of a High-Protein, High-Fiber Beverage Preload on Subjective Appetite Ratings and Subsequent Ad Libitum Energy Intake in Overweight Men and Women: A Randomized, Double-Blind Placebo-Controlled, Crossover Study. Curr Dev Nutr. 2018 Jun 23;2(6):nzy022. doi: 10.1093/cdn/nzy022. eCollection 2018 Jun. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D018753 | Diet, Protein-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Other |
|
| pre-intervention; 10, 20, 30, 60 min post-intervention |
| Visual Analog Scale (VAS) Cravings Questionnaire on scale of 0-100 | A standard VAS Cravings questionnaire will be completed by subjects before pre-load intervention, and at indicated time intervals. The 4 questions assess cravings for sweet, salty, savory, and fatty. 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. | pre-intervention; 10, 20, 30, 60 min post-intervention |
| Subjective Physical Comfort Questionnaire on scale of 0-100 | This questionnaire assesses Gastrointestinal symptoms including Bloating, Belching, Nausea, Diarrhea, and Flatulence. Participants identify if they are currently experiencing the symptom (Yes/No) and if yes, rate the severity of the symptom (Low to High) on a 100 mm scale (0-100). Measures will be made from the left side of the scale, similar to Appetite and Cravings questionnaires. | pre-intervention; immediately post-intervention; 30 min post-intervention |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |