The Effect of a Propionate Colon Release Form on ad Libitum Eating and Appetite Perception (METABIOTIC)
The Effect of a Standardized Liquid Breakfast Containing a Propionate Colon Release Form on ad Libitum Eating and Appetite Perception in Healthy Overweight Humans: A Double-blinded, Randomized, Cross-over Study.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Toronto, Canada
- GI Labs
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or non-pregnant, non-lactating females, 18-60 years of age
- Body mass index (BMI) ≥25 and <30 kg/m² at screening.
- Unrestrained eater (Score of ≤11 on the Eating Habits Questionnaire)
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Subject is willing to abstain from strenuous exercise, and consume alcoholic drinks 24 hours before study days and during study days.
- Willing to refrain from dietary supplement that are known to affect appetite (e.g. some herbal supplements), from prebiotic and probiotic supplements and large amounts of dietary fiber (inulin, metamucil, oat bran, etc) 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.
- Subject regularly has at least one bowel movement per day
Exclusion Criteria:
- Smokers
- Haemoglobin measurements of <120g/L for females and <130g/L for males (as per WHO criteria for anaemia).
- Fasting serum glucose (above or equal to 7.0mmol/L). AST, ALT, GGT and ALP >1.8 times upper limit of normal; creatinine >1.2 times upper limit of normal; fasting triglycerides >4.0 mmol/L; and electrolytes outside the normal range.
- 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/dietary supplements known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might: 1) make participation dangerous to the subject or to others, or 2) affect the results as judged by the Investigator.
- History of propionic acidemia.
- 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).
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the average blood pressure measured at screening.
- 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 4 weeks prior to each test visit.
- History of cancer in the prior two years, except for non-melanoma skin cancer.
- Recent history (within 12 months of screening) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as > 14 drinks per week (1 drink=12 oz beer, 5 oz wine, or 1.5 oz distilled spirits).
- Exposure to any non-registered drug product within 30 d prior to screening.
- Subject has donated more than 300 mL of blood during the three months prior to screening.
- Any history of an eating disorder (eg. anorexia nervosa, bulimia nervosa, binge eating) diagnosed by a health professional
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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EXPERIMENTAL: Propionate (1 g)
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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1 g of Ca-propionate will be mixed in 203 mL of a standardized liquid breakfast
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EXPERIMENTAL: Propionate (3 g)
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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3 g of Ca-propionate will be mixed in 203 mL of a standardized liquid breakfast
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PLACEBO_COMPARATOR: Placebo
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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2.6 g of cellulose will be mixed in 203 mL of a standardized liquid breakfast
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ad-libitum energy intake
Time Frame: t=210 minutes
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Ad-libitum energy intake will be assessed by giving subjects a choice of an excess of individual pizza slices
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t=210 minutes
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Subjective ratings of appetite and GI comfort
Time Frame: Every 30 minutes during an interval of 6 hours
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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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Every 30 minutes during an interval of 6 hours
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24 h food intake
Time Frame: Food intake is recorded from the time of the start of the ad-libitum food test until 24 hours later
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Completion of a food diary
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Food intake is recorded from the time of the start of the ad-libitum food test until 24 hours later
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Serum glucose
Time Frame: Every 30 minutes during an interval of 6 hours
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Serum glucose analysis will be done using either the Vitros 350 Chemistry System or an YSI model 2300/2700 STAT analyser
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Every 30 minutes during an interval of 6 hours
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Plasma insulin
Time Frame: Every 30 minutes during an interval of 6 hours
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Plasma insulin will be measured using an insulin ELISA Immunoassay kit
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Every 30 minutes during an interval of 6 hours
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Plasma ghrelin
Time Frame: Every 30 minutes during an interval of 6 hours
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Immunoassay kits will be used to measure plasma ghrelin
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Every 30 minutes during an interval of 6 hours
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Plasma total glucagon-like peptide-1 (GLP-1)
Time Frame: Every 30 minutes during an interval of 6 hours
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Immunoassay kits will be used for measure plasma total GLP-1
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Every 30 minutes during an interval of 6 hours
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Plasma peptide YY (PYY)
Time Frame: Every 30 minutes during an interval of 6 hours
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Immunoassay kits will be used for measure plasma PYY
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Every 30 minutes during an interval of 6 hours
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Plasma propionate
Time Frame: Every 30 minutes during an interval of 6 hours
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Plasma propionate will be measured using HPLC MS/MS
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Every 30 minutes during an interval of 6 hours
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Thomas Wolever, GI Labs
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2016-11-28-PROP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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