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The Effects of Chia on Overweight/Obese Women

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ClinicalTrials.gov Identifier: NCT03233906
Recruitment Status : Active, not recruiting
First Posted : July 31, 2017
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Desiree Vera, California State Polytechnic University, Pomona

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Obesity Eating Behavior Mood Glucose Dietary Modification Dietary Supplement: Chia Seeds- Salvia Hispanica Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Human subjects- females (18-45 y.o.) with a BMI greater than or equal to 26.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 20, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Salvia

Arm Intervention/treatment
Active Comparator: Chia Seeds
10% of a participants total kcal estimated needs given in chia seeds everyday for 8 weeks.
Dietary Supplement: Chia Seeds- Salvia Hispanica
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.

No Intervention: Control
Habitual diet with avoidance of high fiber and high omega-3 fatty acid foods.



Primary Outcome Measures :
  1. Fasting plasma glucose [ Time Frame: baseline ]
    12-hour fasting plasma glucose levels will be assessed using a glucometer

  2. Waist Circumference [ Time Frame: baseline ]
    waist circumference will be measured for each participant

  3. Caloric intake [ Time Frame: baseline ]
    9, 3-day diet journals will be collected using a paper method

  4. Serotonin [ Time Frame: baseline ]
    Urine serotonin levels will be assessed

  5. Body Weight [ Time Frame: Baseline ]
    Tanita scale

  6. Body Mass Index [ Time Frame: Baseline ]
    Tanita sclae

  7. Body Fat Percentage [ Time Frame: Baseline ]
    Tanita scale

  8. Fasting plasma glucose [ Time Frame: week 4 ]
    2-hour fasting plasma glucose levels will be assessed using a glucometer

  9. Fasting plasma glucose [ Time Frame: week 8 ]
    2-hour fasting plasma glucose levels will be assessed using a glucometer

  10. Waist Circumference [ Time Frame: week 4 ]
    waist circumference will be measured for each participant

  11. Waist Circumference [ Time Frame: week 8 ]
    waist will be measured for each participant

  12. Caloric intake [ Time Frame: week 4 ]
    9, 3-day diet journals will be collected using a paper method

  13. Caloric intake [ Time Frame: week 8 ]
    9, 3-day diet journals will be collected using a paper method

  14. Serotonin [ Time Frame: week 4 ]
    Urine serotonin levels will be assessed

  15. Serotonin [ Time Frame: week 8 ]
    Urine serotonin levels will be assessed

  16. Body Weight [ Time Frame: week 4 ]
    tanita scale

  17. Body weight [ Time Frame: week 8 ]
    tanita scale

  18. Body mass index [ Time Frame: week 4 ]
    tanita scale

  19. body mass index [ Time Frame: week 8 ]
    tanita scale

  20. Body fat percentage [ Time Frame: week 4 ]
    tanita scale

  21. Body fat percentage [ Time Frame: week 8 ]
    tanita scale

  22. Hip Circumference [ Time Frame: Baseline ]
    Hip Circumference will be measured for each participant

  23. Hip Circumference [ Time Frame: week 4 ]
    Hip Circumference will be measured for each participant

  24. Hip Circumference [ Time Frame: week 8 ]
    Hip Circumference will be measured for each participant


Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: baseline ]
    Blood pressure will be taken using an automatic blood pressure machine

  2. Blood Pressure [ Time Frame: week 4 ]
    Blood pressure will be taken using an automatic blood pressure machine

  3. Blood Pressure [ Time Frame: week 8 ]
    Blood pressure will be taken using an automatic blood pressure machine

  4. Joint Pain [ Time Frame: baseline ]
    Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis

  5. Joint Pain [ Time Frame: week 4 ]
    Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis

  6. Joint Pain [ Time Frame: week 8 ]
    Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis

  7. Mood [ Time Frame: Baseline ]
    Major Depression Inventory

  8. Mood [ Time Frame: week 4 ]
    Major Depression Inventory

  9. Mood [ Time Frame: week 8 ]
    Major Depression Inventory

  10. Physical Activity [ Time Frame: Baseline ]
    INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT

  11. Physical Activity [ Time Frame: week 4 ]
    INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT

  12. Physical Activity [ Time Frame: week 8 ]
    INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT

  13. Sleep Quality [ Time Frame: Baseline ]
    Measuring sleep quality using the Pittsburgh Sleep Quality Index

  14. Sleep Quality [ Time Frame: week 4 ]
    Measuring sleep quality using the Pittsburgh Sleep Quality Index

  15. Sleep Quality [ Time Frame: week 8 ]
    Measuring sleep quality using the Pittsburgh Sleep Quality Index

  16. Fat mass [ Time Frame: Baseline ]
    using a tanita scale

  17. Fat mass [ Time Frame: week 4 ]
    using a tanita scale

  18. Fat mass [ Time Frame: week 8 ]
    using a tanita scale

  19. Fat Free Mass [ Time Frame: Baseline ]
    using a tanita scale

  20. Fat Free Mass [ Time Frame: week 4 ]
    using a tanita scale

  21. Fat Free Mass [ Time Frame: week 8 ]
    using a tanita scale

  22. Total body water [ Time Frame: Baseline ]
    using a tanita scale

  23. Total body water [ Time Frame: week 4 ]
    using a tanita scale

  24. Total body water [ Time Frame: week 8 ]
    using a tanita scale

  25. Macro nutrient intake [ Time Frame: Baseline ]
    3, 3-day diet journals will be collected using a paper method

  26. Macro nutrient intake [ Time Frame: week 4 ]
    3, 3-day diet journals will be collected using a paper method

  27. Macro nutrient intake [ Time Frame: week 8 ]
    3, 3-day diet journals will be collected using a paper method

  28. Micronutrient intake [ Time Frame: Baseline ]
    3, 3-day diet journals will be collected using a paper method

  29. Micronutrient intake [ Time Frame: week 4 ]
    3, 3-day diet journals will be collected using a paper method

  30. Micronutrient intake [ Time Frame: week 8 ]
    3, 3-day diet journals will be collected using a paper method

  31. Dietary intake Satiety [ Time Frame: Baseline ]
    3, 3-day diet journals will be collected using a paper method

  32. Dietary intake Satiety [ Time Frame: week 4 ]
    3, 3-day diet journals will be collected using a paper method

  33. Dietary intake Satiety [ Time Frame: week 8 ]
    3, 3-day diet journals will be collected using a paper method

  34. Dietary intake displacement [ Time Frame: Baseline ]
    3, 3-day diet journals will be collected using a paper method

  35. Dietary intake displacement [ Time Frame: week 4 ]
    3, 3-day diet journals will be collected using a paper method

  36. Dietary intake displacement [ Time Frame: week 8 ]
    3, 3-day diet journals will be collected using a paper method



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • consume excess amounts of seeds or nuts.
  • consume alcohol on a regular basis.
  • have a pacemaker or metal pins or plates in the body.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233906


Locations
United States, California
California State Polytechnic University, Pomona
Pomona, California, United States, 91766
Sponsors and Collaborators
California State Polytechnic University, Pomona
Investigators
Study Director: Bonny Burns-Whitmore, DrPh, RD California State Polytechnic University, Pomona

Responsible Party: Desiree Vera, Graduate Student, Human Nutrition and Food Science, California State Polytechnic University, Pomona
ClinicalTrials.gov Identifier: NCT03233906     History of Changes
Other Study ID Numbers: IRB-16-188
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms