Dose Response Effect of Chia Seeds on Subjective Appetite and Glycemic Response

NCT05345470 | Completed

• 1 other identifier: PEP-2117
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. The hypothesis is that chia seeds have a significant effect on hunger and/or fullness.

Conditions

Nutrition, Healthy

Keywords

chia seeds; chia; Salvia hispanica L.; hunger; fullness; satiety; glycemic response

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

  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

  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

  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

  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

  Change from Time 0 -5 min (fasted) to +15, 30, 45, 60, 90, 120, 150 and 180 minutes after starting to eat

Study Arms (4)

0 grams of chia seeds

PLACEBO COMPARATOR

3 cookies (30 grams)

Other: 140 calories per 30 gram test meal

3 grams of chia seeds

EXPERIMENTAL

3 cookies (30 grams)

Other: 140 calories per 30 gram test meal

5 grams of chia seeds

EXPERIMENTAL

3 cookies (30 grams)

Other: 140 calories per 30 gram test meal

7 grams of chia seeds

EXPERIMENTAL

3 cookies (30 grams)

Other: 140 calories per 30 gram test meal

Interventions

140 calories per 30 gram test meal OTHER

Food

0 grams of chia seeds; 3 grams of chia seeds; 5 grams of chia seeds; 7 grams of chia seeds

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Participation in another PepsiCo trial in past 6 months
• 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.
• 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)

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

INQUIS Clinical Research

Toronto, Ontario, M5C 2N8, Canada

Location

Study Officials

• Thomas MS Wolever, MD, PhD

  INQUIS Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 26, 2022
• Study Start: March 17, 2022
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)