The Effect of a High Protein, High Fibre Shake Pre-load on Measures of Satiety and Subsequent Energy Intake

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of a High Protein, High Fibre Shake Pre-load on Measures of Satiety and Subsequent Energy Intake in Healthy Overweight and Obese Subjects: An Acute Randomized, Crossover, Double-blind Placebo-controlled Study

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: High protein, high fiber dietary supplement
* Other: Low protein, low fiber comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant, non-lactating females, 18-50 years of age, inclusive Body mass index (BMI) between 27 and 33 kg/m² inclusive at screening. Blood pressure < 130/85. Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial. Willing to abstain from strenuous exercise, consumption of alcoholic drinks and caffeine-containing food/drinks 24 hours before study days and during study days (until study completion for that day). Willing to maintain current dietary supplement (if applicable) use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit. Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history. Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator. Female subjects are willing to use a contraceptive method to avoid pregnancy during the study period. Exclusion Criteria: Failure to meet any one of the inclusion criteria Smokers Known history of AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders. Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, blood thinners, diuretics, thiazolidinediones, metformin, antibiotics and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might, in the opinion of Dr. Wolever, the president of GI labs, either: 1) make participation dangerous to the subject or to others, or 2) affect the results. Major trauma or surgical event within 3 months of screening. Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines. Known intolerance, sensitivity or allergy to any ingredients in the study products. Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc).. Change in body weight of >3.5kg within 4 weeks of the screening visit. Presence of any signs or symptoms of an active infection within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment (i.e. antibiotic therapy) has been completed at least 5 d prior to each test visit. History of cancer in the prior two years, except for non-melanoma skin cancer. Exposure to any non-registered drug product within 30 d prior to screening. Pregnancy or breastfeeding Any history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating) diagnosed by a health professional

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high protein, high fiber<br>Participants receive a high protein, high fiber dietary supplement pre-load | Dietary Supplement: High protein, high fiber dietary supplement<br> <br> |
| Placebo Comparator: Low protein, low fiber<br>Participants receive a low protein, low fiber isocaloric pre-load | Other: Low protein, low fiber comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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satiety, protein, fiber