- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02979717
The Effect of a High Protein, High Fibre Shake Pre-load on Measures of Satiety and Subsequent Energy Intake
March 28, 2017 updated by: Beachbody
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5C 2N8
- Glycemic Index Laboratories, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: high protein, high fiber
Participants receive a high protein, high fiber dietary supplement pre-load
|
|
Placebo Comparator: Low protein, low fiber
Participants receive a low protein, low fiber isocaloric pre-load
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy intake (total kilocalories) at meal subsequent to intervention pre-load
Time Frame: 1 hour post-intervention
|
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
Time Frame: pre-intervention; 10, 20, 30, 60 min post-intervention
|
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
Time Frame: pre-intervention; 10, 20, 30, 60 min post-intervention
|
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
Time Frame: pre-intervention; immediately post-intervention; 30 min post-intervention
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Wolever, PhD,DM(Oxon), Glycemic Index Laboratories, Inc
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 23, 2016
Primary Completion (Actual)
March 14, 2017
Study Completion (Actual)
March 14, 2017
Study Registration Dates
First Submitted
November 28, 2016
First Submitted That Met QC Criteria
December 1, 2016
First Posted (Estimate)
December 2, 2016
Study Record Updates
Last Update Posted (Actual)
March 29, 2017
Last Update Submitted That Met QC Criteria
March 28, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIL-1653
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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