OverweightMETABIOTICNCT04019951
The Effect of a Propionate Colon Release Form on ad Libitum Eating and Appetite Perception
A study testing Ca-propionate 1 g and Ca-propionate 3 g in people with Overweight, run by dsm-firmenich Switzerland AG at 1 site in Canada.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Ca-propionate 1 g and Ca-propionate 3 g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2019to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
Read the detailed description
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
- Conditions
- Overweight
- Being tested
- Ca-propionate 1 g, Ca-propionate 3 g, Placebo
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ca-propionate 1 gDietary supplement
1 g of Ca-propionate will be mixed in 203 mL of a standardized liquid breakfast
Ca-propionate 3 gDietary supplement
3 g of Ca-propionate will be mixed in 203 mL of a standardized liquid breakfast
PlaceboDietary supplement
2.6 g of cellulose will be mixed in 203 mL of a standardized liquid breakfast
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Ca-propionate 1 g |
| 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. Receives: Dietary Supplement: Ca-propionate 3 g |
| 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad-libitum energy intake
Ad-libitum energy intake will be assessed by giving subjects a choice of an excess of individual pizza slices
Measured: t=210 minutes
Secondary outcomes (8)
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.
Measured: Every 30 minutes during an interval of 6 hours
24 h food intake
Completion of a food diary
Measured: 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
Measured: Every 30 minutes during an interval of 6 hours
Plasma insulin
Plasma insulin will be measured using an insulin ELISA Immunoassay kit
Measured: Every 30 minutes during an interval of 6 hours
Plasma ghrelin
Immunoassay kits will be used to measure plasma ghrelin
Measured: 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
Measured: Every 30 minutes during an interval of 6 hours
Plasma peptide YY (PYY)
Immunoassay kits will be used for measure plasma PYY
Measured: Every 30 minutes during an interval of 6 hours
Plasma propionate
Plasma propionate will be measured using HPLC MS/MS
Measured: Every 30 minutes during an interval of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start1 Jan 2019
- Primary completion1 Oct 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glycemic Index Laboratories, Inc
- Responsible party
- Sponsor
- Investigators
- Thomas Wolever, Principal investigator, GI Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019951
- Sponsor's protocol ID
- 2016-11-28-PROP
- Acronym
- METABIOTIC
- Status last verified
- Mar 2020
- First submitted
- 9 Jul 2019
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04019951
- Acronym / sponsor ID
- METABIOTIC / 2016-11-28-PROP
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Collaborators
- Glycemic Index Laboratories, Inc
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propionate (1 g) | Experimental | Dietary Supplement: Ca-propionate 1 gParticipants 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. |
| Propionate (3 g) | Experimental | Dietary Supplement: Ca-propionate 3 gParticipants 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ca-propionate 1 g1 g of Ca-propionate will be mixed in 203 mL of a standardized liquid breakfast | Dietary supplement | Propionate (1 g) |
| Ca-propionate 3 g3 g of Ca-propionate will be mixed in 203 mL of a standardized liquid breakfast | Dietary supplement | Propionate (3 g) |
| Placebo2.6 g of cellulose will be mixed in 203 mL of a standardized liquid breakfast | Dietary supplement | Placebo |
Primary outcome
Ad-libitum energy intake
Time frame: t=210 minutes
Ad-libitum energy intake will be assessed by giving subjects a choice of an excess of individual pizza slices
8 secondary outcomes
Subjective ratings of appetite and GI comfort
Time frame: Every 30 minutes during an interval of 6 hours
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
Serum glucose
Time frame: Every 30 minutes during an interval of 6 hours
Plasma insulin
Time frame: Every 30 minutes during an interval of 6 hours
Plasma ghrelin
Time frame: Every 30 minutes during an interval of 6 hours
Plasma total glucagon-like peptide-1 (GLP-1)
Time frame: Every 30 minutes during an interval of 6 hours
Plasma peptide YY (PYY)
Time frame: Every 30 minutes during an interval of 6 hours
Plasma propionate
Time frame: Every 30 minutes during an interval of 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Wolever principal investigator
GI Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ca-propionate 1 g and Ca-propionate 3 g in people with Overweight, run by dsm-firmenich Switzerland AG at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ad-libitum energy intake (time frame: t=210 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.