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ObesityNCT03233906

The Effects of Chia on Overweight/Obese Women

A study testing Chia Seeds- Salvia Hispanica in people with Obesity and Eating Behavior, run by California State Polytechnic University, Pomona at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the study is to examine the effect of chia seed consumption on body composition, blood pressure, blood glucose, satiety, mood, joint pain, and dietary displacement in overweight and obese females (18-45years). Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Eating Behavior, Mood
What is being tested?
Chia Seeds- Salvia Hispanica
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
20 May 2017to Aug 2018
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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • are a female.
  • are between the ages of 18 and 45.
  • are not averse to consuming chia seeds on a regular basis (at least six weeks).
  • have not taken any medication for any chronic disease (heart, diabetes, cancer) for twelve weeks.
  • have not taken any steroid or hormone medication in the last eight weeks, excluding birth control pills...
  • do not consume excess amounts of nuts and seeds. - do not consume alcohol on a regular basis.
  • are not currently on a diet plan.
  • are not pregnant or plan to become pregnant.

Who cannot join

  • are a child, teenager, woman, or male younger than 18 or older than 45.
  • eat large quantities of chia seeds on a regular basis.
  • are taking any steroid or hormone medication (other than birth control pills). - are taking laxatives or fiber containing supplements on a regular basis.
  • are pregnant or become pregnant.
  • are currently on a diet plan.
  • have a known allergy to seeds.
Show all 9Show fewer
  • consume excess amounts of seeds or nuts.
  • consume alcohol on a regular basis.
  • have a pacemaker or metal pins or plates in the body.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • California State Polytechnic University, Pomona

    Pomona, California, 91766

Other trials in United States

About this study

Official title: Effects of Chia Seed Consumption on Body Composition, Blood Pressure, Blood Glucose, Satiety, Diet Displacement, Joint Pain, Mood and Serotonin Levels in Young, Healthy, Overweight/Obese Females

The purpose of the study is to examine the effect of chia seed consumption on body composition, blood pressure, blood glucose, satiety, mood, joint pain, and dietary displacement in overweight and obese females (18-45years). It is hypothesized that consuming chia seeds will bring about a positive change in body composition (lower % body fat), satiety, mood, joint pain, and blood pressure, lower blood glucose levels, increased fiber and improved nutrient intake, in overweight/ obese females.

Read the detailed description

Specific Objectives: 1. Determine if chia seed diet addition of 10% of Kcals (CHIA) positively changes body composition in young, healthy, overweight/obese people (Tanita scale). A) Determine if CHIA will decrease blood pressure (monitor). 2. Determine if CHIA will decrease blood glucose (draw) 3. Determine if CHIA increases satiety and improves diet (recordings). 4. Determine if CHIA will decrease joint pain (questionnaire). 5. Determine if CHIA will increase positive mood changes (questionnaires) and increase blood serotonin levels (draw).

Being tested
Chia Seeds- Salvia Hispanica
Medical subject headings
Obesity, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chia Seeds- Salvia HispanicaDietary supplement

    Chia seed added-10% of kcals and a no-chia control diet. 10% will be calculated using the following formula: Harris-Benedict equation multiplied by the activity factor of 1.2, 1.375, and 1.55 depending on each participant's activity level based on the information provided on the initial screening form.

Study groups in NCT03233906
Study groupRoleWhat they receive
Chia SeedsActive comparator10% of a participants total kcal estimated needs given in chia seeds everyday for 8 weeks.
Receives: Dietary Supplement: Chia Seeds- Salvia Hispanica
ControlNo interventionHabitual diet with avoidance of high fiber and high omega-3 fatty acid foods.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting plasma glucose

    12-hour fasting plasma glucose levels will be assessed using a glucometer

    Measured: baseline

  2. Waist Circumference

    waist circumference will be measured for each participant

    Measured: baseline

  3. Caloric intake

    9, 3-day diet journals will be collected using a paper method

    Measured: baseline

  4. Serotonin

    Urine serotonin levels will be assessed

    Measured: baseline

  5. Body Weight

    Tanita scale

    Measured: Baseline

  6. Body Mass Index

    Tanita sclae

    Measured: Baseline

  7. Body Fat Percentage

    Tanita scale

    Measured: Baseline

  8. Fasting plasma glucose

    2-hour fasting plasma glucose levels will be assessed using a glucometer

    Measured: week 4

  9. Fasting plasma glucose

    2-hour fasting plasma glucose levels will be assessed using a glucometer

    Measured: week 8

  10. Waist Circumference

    waist circumference will be measured for each participant

    Measured: week 4

  11. Waist Circumference

    waist will be measured for each participant

    Measured: week 8

  12. Caloric intake

    9, 3-day diet journals will be collected using a paper method

    Measured: week 4

  13. Caloric intake

    9, 3-day diet journals will be collected using a paper method

    Measured: week 8

  14. Serotonin

    Urine serotonin levels will be assessed

    Measured: week 4

  15. Serotonin

    Urine serotonin levels will be assessed

    Measured: week 8

  16. Body Weight

    tanita scale

    Measured: week 4

  17. Body weight

    tanita scale

    Measured: week 8

  18. Body mass index

    tanita scale

    Measured: week 4

  19. body mass index

    tanita scale

    Measured: week 8

  20. Body fat percentage

    tanita scale

    Measured: week 4

  21. Body fat percentage

    tanita scale

    Measured: week 8

  22. Hip Circumference

    Hip Circumference will be measured for each participant

    Measured: Baseline

  23. Hip Circumference

    Hip Circumference will be measured for each participant

    Measured: week 4

  24. Hip Circumference

    Hip Circumference will be measured for each participant

    Measured: week 8

Secondary outcomes (36)

  1. Blood Pressure

    Blood pressure will be taken using an automatic blood pressure machine

    Measured: baseline

  2. Blood Pressure

    Blood pressure will be taken using an automatic blood pressure machine

    Measured: week 4

  3. Blood Pressure

    Blood pressure will be taken using an automatic blood pressure machine

    Measured: week 8

  4. Joint Pain

    Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis

    Measured: baseline

  5. Joint Pain

    Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis

    Measured: week 4

  6. Joint Pain

    Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis

    Measured: week 8

  7. Mood

    Major Depression Inventory

    Measured: Baseline

  8. Mood

    Major Depression Inventory

    Measured: week 4

  9. Mood

    Major Depression Inventory

    Measured: week 8

  10. Physical Activity

    INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT

    Measured: Baseline

  11. Physical Activity

    INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT

    Measured: week 4

  12. Physical Activity

    INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT

    Measured: week 8

  13. Sleep Quality

    Measuring sleep quality using the Pittsburgh Sleep Quality Index

    Measured: Baseline

  14. Sleep Quality

    Measuring sleep quality using the Pittsburgh Sleep Quality Index

    Measured: week 4

  15. Sleep Quality

    Measuring sleep quality using the Pittsburgh Sleep Quality Index

    Measured: week 8

  16. Fat mass

    using a tanita scale

    Measured: Baseline

  17. Fat mass

    using a tanita scale

    Measured: week 4

  18. Fat mass

    using a tanita scale

    Measured: week 8

  19. Fat Free Mass

    using a tanita scale

    Measured: Baseline

  20. Fat Free Mass

    using a tanita scale

    Measured: week 4

  21. Fat Free Mass

    using a tanita scale

    Measured: week 8

  22. Total body water

    using a tanita scale

    Measured: Baseline

  23. Total body water

    using a tanita scale

    Measured: week 4

  24. Total body water

    using a tanita scale

    Measured: week 8

  25. Macro nutrient intake

    3, 3-day diet journals will be collected using a paper method

    Measured: Baseline

  26. Macro nutrient intake

    3, 3-day diet journals will be collected using a paper method

    Measured: week 4

  27. Macro nutrient intake

    3, 3-day diet journals will be collected using a paper method

    Measured: week 8

  28. Micronutrient intake

    3, 3-day diet journals will be collected using a paper method

    Measured: Baseline

  29. Micronutrient intake

    3, 3-day diet journals will be collected using a paper method

    Measured: week 4

  30. Micronutrient intake

    3, 3-day diet journals will be collected using a paper method

    Measured: week 8

  31. Dietary intake Satiety

    3, 3-day diet journals will be collected using a paper method

    Measured: Baseline

  32. Dietary intake Satiety

    3, 3-day diet journals will be collected using a paper method

    Measured: week 4

  33. Dietary intake Satiety

    3, 3-day diet journals will be collected using a paper method

    Measured: week 8

  34. Dietary intake displacement

    3, 3-day diet journals will be collected using a paper method

    Measured: Baseline

  35. Dietary intake displacement

    3, 3-day diet journals will be collected using a paper method

    Measured: week 4

  36. Dietary intake displacement

    3, 3-day diet journals will be collected using a paper method

    Measured: week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2017
  2. Study start20 May 2017
  3. Primary completionMay 2018 (estimated)
  4. Study completionAug 2018 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Human subjects- females (18-45 y.o.) with a BMI greater than or equal to 26.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03233906
Sponsor's protocol ID
IRB-16-188
Status last verified
May 2018
First submitted
17 Jul 2017
Last updated
11 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Chia Seeds- Salvia Hispanica in people with Obesity and Eating Behavior, run by California State Polytechnic University, Pomona at 1 site in United States.

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 8 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: status not confirmed, as of the sponsor's last update on 11 May 2018. 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 United States. 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. 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?

Results are not available in the source record.

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?

Fasting plasma glucose (time frame: baseline). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03233906.

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 11 May 2018.

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