Nutrition, HealthyNCT05345470
Dose Response Effect of Chia Seeds on Subjective Appetite and Glycemic Response
A study testing 140 calories per 30 gram test meal in people with Nutrition, Healthy, run by PepsiCo Global R&D at 1 site in Canada.
Trial summary
To compare subjective appetite, satiety and glycemic responses for 3 h after consumption of investigational products containing 0, 3, 5 and 7 grams of chia seeds, controlling for energy intake. The primary objective is to compare total area under the curves (tAUC) of hunger and fullness ratings. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- 140 calories per 30 gram test meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 17 Mar 2022to 24 Jun 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-pregnant, non-lactating, healthy individuals; at least n=45 aged 18-55 years and up to n=5 aged 56-65 years, inclusive
- BMI 18.5 to 34.9 kg/m², inclusive
- No history of diabetes mellitus
- Systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg
- No major illness, trauma or surgery requiring hospitalization within 3 months of the screening visit
- Ability to understand the study procedures and willing to provide informed consent to participate in the study
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- Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP
- Subjects are willing to follow current Covid guidelines with respect to attending study visits
- Subjects are willing to sign the informed consent prior to any procedures conducted
Who cannot join
- Participation in another PepsiCo trial in past 6 months
- Failure to meet any one of the inclusion criteria
- High alcohol consumption (>14 drinks per week and >4 drinks per day for males; and >7 drinks per week and >3 drinks per day for females), or history of alcohol or drug abuse.
- Individuals with a history of bariatric surgery, gastrointestinal disease, moderate or severe renal failure, moderate or severe liver disease or any other medical conditions or use of supplements or medications that increase risk to the subject or others or may affect the results, as judged by the Principal Investigator
- Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines
- Known intolerance, sensitivity, or allergy to any ingredients in the study test products.
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- Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification.
- Reported weight change of > 5kg in the preceding 3 months
- History of an eating disorder (e.g., anorexia, bulimia, binge eating, pica, rumination, avoidant/restrictive food intake disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Response Effect of Chia Seeds on Subjective Appetite and Glycemic Response: a Single Center, Randomized Cross-over Study in Healthy Adults
To compare subjective appetite, satiety and glycemic responses for 3 h after consumption of investigational products containing 0, 3, 5 and 7 grams of chia seeds, controlling for energy intake. The primary objective is to compare total area under the curves (tAUC) of hunger and fullness ratings. The hypothesis is that chia seeds have a significant effect on hunger and/or fullness.
Read the detailed description
Current nutrition guidelines in the United States and Canada recommend meeting protein needs with nutrient-dense foods among which include legumes, nuts, and seeds. Chia seeds are very high in dietary fiber, low in available-carbohydrate (avCHO), and good sources of alpha-linoleic acid, protein, and micronutrients. Chia has attracted interest as a functional food with studies showing several potential beneficial effects on health, among them their ability to increase satiety and/or reduce food intake. The effect on satiety of doses of chia less than 7g is not known. The primary objective of this study is to compare total area under the curves (tAUC) of hunger and fullness ratings for 3h after consumption among test-meals containing 0, 3, 5 and 7g of chia seeds, controlling for energy intake.
Secondary objectives are tAUC of desire to eat and prospective consumption, tAUC of average appetite, tAUC of subjective appetite ratings from 0-2, 2-3 and 0-3h, Effects of time and dose and the time×dose interaction of plasma glucose concentrations and increments for 3h after consuming the test products, Incremental area under the curve (iAUC) of plasma glucose over 0-2h, 2-3h and 0-3h, and Plasma glucose peak rise.
Main effects of chia dose, time, and the dose×time interaction will be examined. After demonstrating a significant interaction, individual endpoints will be assessed for the main effect of dose. The significance of differences between doses will be assessed.
- Conditions
- Nutrition, Healthy
- Being tested
- 140 calories per 30 gram test meal
- Keywords
- chia seeds, chia, Salvia hispanica L., hunger, fullness, satiety, glycemic response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
140 calories per 30 gram test mealOther
Food
| Study group | Role | What they receive |
|---|---|---|
| 0 grams of chia seeds | Placebo comparator | 3 cookies (30 grams) Receives: Other: 140 calories per 30 gram test meal |
| 3 grams of chia seeds | Experimental | 3 cookies (30 grams) Receives: Other: 140 calories per 30 gram test meal |
| 5 grams of chia seeds | Experimental | 3 cookies (30 grams) Receives: Other: 140 calories per 30 gram test meal |
| 7 grams of chia seeds | Experimental | 3 cookies (30 grams) Receives: Other: 140 calories per 30 gram test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total area under the curve (tAUC) of hunger ratings among test-meals containing 0, 3, 5 and 7 grams of chia seeds.
Visual Analog Scale (VAS) Motivation to Eat Questionnaire, vertical mark on 100 mm line from 0=Not very hungry at all to 100= As hungry as I have ever felt
Measured: Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Total area under the curve (tAUC) of fullness ratings among test-meals containing 0, 3, 5 and 7 grams of chia seeds.
Visual Analog Scale (VAS) Motivation to Eat Questionnaire, vertical mark on 100 mm line from 0=Not full at all to 100=As full as I have ever felt
Measured: Change from Time 0 -5 min(fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Secondary outcomes (7)
Total area under the curve (tAUC) of desire to eat
Visual Analog Scale (VAS) Motivation to Eat Questionnaire, vertical mark on 100 mm line from 0=Very weak to 100=Very strong
Measured: Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Total area under the curve (tAUC) of prospective consumption
Visual Analog Scale (VAS) Motivation to Eat Questionnaire, vertical mark on100 mm line from 0=Nothing at all to 100= A large amount
Measured: Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Total area under the curve (tAUC) of average appetite
Average Appetite will be calculated as (Desire to Eat + Hunger + (100-Fullness) + Prospective consumption)/4
Measured: Change from Time 0 -5 minutes (fasted) to 2, 2-3 and 0-3 hours
Total area under the curve (tAUC) of subjective appetite ratings
Measured using the Motivation to eat Visual Analog Scale (VAS) which consists of 4 questions assessing Desire to Eat, Hunger, Fullness, and Prospective Consumption
Measured: Change from Time 0 -5 minutes (fasted) to 2, 2-3 and 0-3 hours
Effects of time and dose and the time × dose interaction of plasma glucose concentrations and increments
Main effects assessed using ANOVA. Differences between doses assessed using Tukey's test to adjust for multiple comparisons.
Measured: Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Incremental area under the curve (iAUC) of plasma glucose
Capillary blood via finger sticks centrifuged. Plasma glucose analyzed using a Vitros 350 Chemistry System
Measured: Time 0 - 5 min (fasted) to 2, 2-3 and 0-3 hours after starting to eat
Plasma glucose peak rise
The maximum glucose value
Measured: Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start17 Mar 2022
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas MS Wolever, MD, PhD, Principal investigator, INQUIS Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345470
- Sponsor's protocol ID
- PEP-2117
- Status last verified
- Jul 2022
- First submitted
- 18 Apr 2022
- Last updated
- 8 Jul 2022
- 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 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Effect of Chia Seeds on Subjective Appetite and Glycemic Response: a Single Center, Randomized Cross-over Study in Healthy Adults
- ClinicalTrials.gov ID
- NCT05345470
- Acronym / sponsor ID
- PEP-2117
- Conditions
- Nutrition, Healthy
- Keywords
- chia seeds, chia, Salvia hispanica L., hunger, fullness, satiety, glycemic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 26 Apr 2022 (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.
To compare subjective appetite, satiety and glycemic responses for 3 h after consumption of investigational products containing 0, 3, 5 and 7 grams of chia seeds, controlling for energy intake. The primary objective is to compare total area under the curves (tAUC) of hunger and fullness ratings. The hypothesis is that chia seeds have a significant effect on hunger and/or fullness.
Detailed description
Current nutrition guidelines in the United States and Canada recommend meeting protein needs with nutrient-dense foods among which include legumes, nuts, and seeds. Chia seeds are very high in dietary fiber, low in available-carbohydrate (avCHO), and good sources of alpha-linoleic acid, protein, and micronutrients. Chia has attracted interest as a functional food with studies showing several potential beneficial effects on health, among them their ability to increase satiety and/or reduce food intake. The effect on satiety of doses of chia less than 7g is not known. The primary objective of this study is to compare total area under the curves (tAUC) of hunger and fullness ratings for 3h after consumption among test-meals containing 0, 3, 5 and 7g of chia seeds, controlling for energy intake.
Secondary objectives are tAUC of desire to eat and prospective consumption, tAUC of average appetite, tAUC of subjective appetite ratings from 0-2, 2-3 and 0-3h, Effects of time and dose and the time×dose interaction of plasma glucose concentrations and increments for 3h after consuming the test products, Incremental area under the curve (iAUC) of plasma glucose over 0-2h, 2-3h and 0-3h, and Plasma glucose peak rise.
Main effects of chia dose, time, and the dose×time interaction will be examined. After demonstrating a significant interaction, individual endpoints will be assessed for the main effect of dose. The significance of differences between doses will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0 grams of chia seeds | Placebo comparator | Other: 140 calories per 30 gram test meal3 cookies (30 grams) |
| 3 grams of chia seeds | Experimental | Other: 140 calories per 30 gram test meal3 cookies (30 grams) |
| 5 grams of chia seeds | Experimental | Other: 140 calories per 30 gram test meal3 cookies (30 grams) |
| 7 grams of chia seeds | Experimental | Other: 140 calories per 30 gram test meal3 cookies (30 grams) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Non-pregnant, non-lactating, healthy individuals; at least n=45 aged 18-55 years and up to n=5 aged 56-65 years, inclusive
- BMI 18.5 to 34.9 kg/m², inclusive
- No history of diabetes mellitus
- Systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg
- No major illness, trauma or surgery requiring hospitalization within 3 months of the screening visit
Key exclusion criteria (9 listed)
- Participation in another PepsiCo trial in past 6 months
- Failure to meet any one of the inclusion criteria
- High alcohol consumption (>14 drinks per week and >4 drinks per day for males; and >7 drinks per week and >3 drinks per day for females), or history of alcohol or drug abuse.
- Individuals with a history of bariatric surgery, gastrointestinal disease, moderate or severe renal failure, moderate or severe liver disease or any other medical conditions or use of supplements or medications that increase risk to the subject or others or may affect the results, as judged by the Principal Investigator
- Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines
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 |
|---|---|---|
| 140 calories per 30 gram test mealFood | Other | 0 grams of chia seeds, 3 grams of chia seeds, 5 grams of chia seeds, 7 grams of chia seeds |
Primary outcome
Total area under the curve (tAUC) of hunger ratings among test-meals containing 0, 3, 5 and 7 grams of chia seeds.
Time frame: Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Visual Analog Scale (VAS) Motivation to Eat Questionnaire, vertical mark on 100 mm line from 0=Not very hungry at all to 100= As hungry as I have ever felt
Total area under the curve (tAUC) of fullness ratings among test-meals containing 0, 3, 5 and 7 grams of chia seeds.
Time frame: Change from Time 0 -5 min(fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Visual Analog Scale (VAS) Motivation to Eat Questionnaire, vertical mark on 100 mm line from 0=Not full at all to 100=As full as I have ever felt
7 secondary outcomes
Total area under the curve (tAUC) of desire to eat
Time frame: Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Total area under the curve (tAUC) of prospective consumption
Time frame: Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Total area under the curve (tAUC) of average appetite
Time frame: Change from Time 0 -5 minutes (fasted) to 2, 2-3 and 0-3 hours
Total area under the curve (tAUC) of subjective appetite ratings
Time frame: Change from Time 0 -5 minutes (fasted) to 2, 2-3 and 0-3 hours
Effects of time and dose and the time × dose interaction of plasma glucose concentrations and increments
Time frame: Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
Incremental area under the curve (iAUC) of plasma glucose
Time frame: Time 0 - 5 min (fasted) to 2, 2-3 and 0-3 hours after starting to eat
Plasma glucose peak rise
Time frame: Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat
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 8 Jul 2022.
- 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 MS Wolever, MD, PhD principal investigator
INQUIS Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 140 calories per 30 gram test meal in people with Nutrition, Healthy, run by PepsiCo Global R&D 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 9 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 8 Jul 2022. 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?
Total area under the curve (tAUC) of hunger ratings among test-meals containing 0, 3, 5 and 7 grams of chia seeds. (time frame: Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat). The study lists 2 primary outcomes in all. 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 8 Jul 2022.