Back to resultsThe Effects of Chia on Overweight/Obese Women
Primary Purpose
Obesity, Eating Behavior, Mood
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chia Seeds- Salvia Hispanica
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility 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.
Sites / Locations
- California State Polytechnic University, Pomona
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Chia Seeds
Control
Arm Description
10% of a participants total kcal estimated needs given in chia seeds everyday for 8 weeks.
Habitual diet with avoidance of high fiber and high omega-3 fatty acid foods.
Outcomes
Primary Outcome Measures
Fasting plasma glucose
12-hour fasting plasma glucose levels will be assessed using a glucometer
Waist Circumference
waist circumference will be measured for each participant
Caloric intake
9, 3-day diet journals will be collected using a paper method
Serotonin
Urine serotonin levels will be assessed
Body Weight
Tanita scale
Body Mass Index
Tanita sclae
Body Fat Percentage
Tanita scale
Fasting plasma glucose
2-hour fasting plasma glucose levels will be assessed using a glucometer
Fasting plasma glucose
2-hour fasting plasma glucose levels will be assessed using a glucometer
Waist Circumference
waist circumference will be measured for each participant
Waist Circumference
waist will be measured for each participant
Caloric intake
9, 3-day diet journals will be collected using a paper method
Caloric intake
9, 3-day diet journals will be collected using a paper method
Serotonin
Urine serotonin levels will be assessed
Serotonin
Urine serotonin levels will be assessed
Body Weight
tanita scale
Body weight
tanita scale
Body mass index
tanita scale
body mass index
tanita scale
Body fat percentage
tanita scale
Body fat percentage
tanita scale
Hip Circumference
Hip Circumference will be measured for each participant
Hip Circumference
Hip Circumference will be measured for each participant
Hip Circumference
Hip Circumference will be measured for each participant
Secondary Outcome Measures
Blood Pressure
Blood pressure will be taken using an automatic blood pressure machine
Blood Pressure
Blood pressure will be taken using an automatic blood pressure machine
Blood Pressure
Blood pressure will be taken using an automatic blood pressure machine
Joint Pain
Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis
Joint Pain
Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis
Joint Pain
Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis
Mood
Major Depression Inventory
Mood
Major Depression Inventory
Mood
Major Depression Inventory
Physical Activity
INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT
Physical Activity
INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT
Physical Activity
INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT
Sleep Quality
Measuring sleep quality using the Pittsburgh Sleep Quality Index
Sleep Quality
Measuring sleep quality using the Pittsburgh Sleep Quality Index
Sleep Quality
Measuring sleep quality using the Pittsburgh Sleep Quality Index
Fat mass
using a tanita scale
Fat mass
using a tanita scale
Fat mass
using a tanita scale
Fat Free Mass
using a tanita scale
Fat Free Mass
using a tanita scale
Fat Free Mass
using a tanita scale
Total body water
using a tanita scale
Total body water
using a tanita scale
Total body water
using a tanita scale
Macro nutrient intake
3, 3-day diet journals will be collected using a paper method
Macro nutrient intake
3, 3-day diet journals will be collected using a paper method
Macro nutrient intake
3, 3-day diet journals will be collected using a paper method
Micronutrient intake
3, 3-day diet journals will be collected using a paper method
Micronutrient intake
3, 3-day diet journals will be collected using a paper method
Micronutrient intake
3, 3-day diet journals will be collected using a paper method
Dietary intake Satiety
3, 3-day diet journals will be collected using a paper method
Dietary intake Satiety
3, 3-day diet journals will be collected using a paper method
Dietary intake Satiety
3, 3-day diet journals will be collected using a paper method
Dietary intake displacement
3, 3-day diet journals will be collected using a paper method
Dietary intake displacement
3, 3-day diet journals will be collected using a paper method
Dietary intake displacement
3, 3-day diet journals will be collected using a paper method
Full Information
NCT ID
NCT03233906
First Posted
July 17, 2017
Last Updated
May 8, 2018
Sponsor
California State Polytechnic University, Pomona
1. Study Identification
Unique Protocol Identification Number
NCT03233906
Brief Title
The Effects of Chia on Overweight/Obese Women
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2017 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California State Polytechnic University, Pomona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Eating Behavior, Mood, Glucose, Dietary Modification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Human subjects- females (18-45 y.o.) with a BMI greater than or equal to 26.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chia Seeds
Arm Type
Active Comparator
Arm Description
10% of a participants total kcal estimated needs given in chia seeds everyday for 8 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Habitual diet with avoidance of high fiber and high omega-3 fatty acid foods.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chia Seeds- Salvia Hispanica
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fasting plasma glucose
Description
12-hour fasting plasma glucose levels will be assessed using a glucometer
Time Frame
baseline
Title
Waist Circumference
Description
waist circumference will be measured for each participant
Time Frame
baseline
Title
Caloric intake
Description
9, 3-day diet journals will be collected using a paper method
Time Frame
baseline
Title
Serotonin
Description
Urine serotonin levels will be assessed
Time Frame
baseline
Title
Body Weight
Description
Tanita scale
Time Frame
Baseline
Title
Body Mass Index
Description
Tanita sclae
Time Frame
Baseline
Title
Body Fat Percentage
Description
Tanita scale
Time Frame
Baseline
Title
Fasting plasma glucose
Description
2-hour fasting plasma glucose levels will be assessed using a glucometer
Time Frame
week 4
Title
Fasting plasma glucose
Description
2-hour fasting plasma glucose levels will be assessed using a glucometer
Time Frame
week 8
Title
Waist Circumference
Description
waist circumference will be measured for each participant
Time Frame
week 4
Title
Waist Circumference
Description
waist will be measured for each participant
Time Frame
week 8
Title
Caloric intake
Description
9, 3-day diet journals will be collected using a paper method
Time Frame
week 4
Title
Caloric intake
Description
9, 3-day diet journals will be collected using a paper method
Time Frame
week 8
Title
Serotonin
Description
Urine serotonin levels will be assessed
Time Frame
week 4
Title
Serotonin
Description
Urine serotonin levels will be assessed
Time Frame
week 8
Title
Body Weight
Description
tanita scale
Time Frame
week 4
Title
Body weight
Description
tanita scale
Time Frame
week 8
Title
Body mass index
Description
tanita scale
Time Frame
week 4
Title
body mass index
Description
tanita scale
Time Frame
week 8
Title
Body fat percentage
Description
tanita scale
Time Frame
week 4
Title
Body fat percentage
Description
tanita scale
Time Frame
week 8
Title
Hip Circumference
Description
Hip Circumference will be measured for each participant
Time Frame
Baseline
Title
Hip Circumference
Description
Hip Circumference will be measured for each participant
Time Frame
week 4
Title
Hip Circumference
Description
Hip Circumference will be measured for each participant
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Blood pressure will be taken using an automatic blood pressure machine
Time Frame
baseline
Title
Blood Pressure
Description
Blood pressure will be taken using an automatic blood pressure machine
Time Frame
week 4
Title
Blood Pressure
Description
Blood pressure will be taken using an automatic blood pressure machine
Time Frame
week 8
Title
Joint Pain
Description
Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis
Time Frame
baseline
Title
Joint Pain
Description
Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis
Time Frame
week 4
Title
Joint Pain
Description
Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis
Time Frame
week 8
Title
Mood
Description
Major Depression Inventory
Time Frame
Baseline
Title
Mood
Description
Major Depression Inventory
Time Frame
week 4
Title
Mood
Description
Major Depression Inventory
Time Frame
week 8
Title
Physical Activity
Description
INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT
Time Frame
Baseline
Title
Physical Activity
Description
INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT
Time Frame
week 4
Title
Physical Activity
Description
INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT
Time Frame
week 8
Title
Sleep Quality
Description
Measuring sleep quality using the Pittsburgh Sleep Quality Index
Time Frame
Baseline
Title
Sleep Quality
Description
Measuring sleep quality using the Pittsburgh Sleep Quality Index
Time Frame
week 4
Title
Sleep Quality
Description
Measuring sleep quality using the Pittsburgh Sleep Quality Index
Time Frame
week 8
Title
Fat mass
Description
using a tanita scale
Time Frame
Baseline
Title
Fat mass
Description
using a tanita scale
Time Frame
week 4
Title
Fat mass
Description
using a tanita scale
Time Frame
week 8
Title
Fat Free Mass
Description
using a tanita scale
Time Frame
Baseline
Title
Fat Free Mass
Description
using a tanita scale
Time Frame
week 4
Title
Fat Free Mass
Description
using a tanita scale
Time Frame
week 8
Title
Total body water
Description
using a tanita scale
Time Frame
Baseline
Title
Total body water
Description
using a tanita scale
Time Frame
week 4
Title
Total body water
Description
using a tanita scale
Time Frame
week 8
Title
Macro nutrient intake
Description
3, 3-day diet journals will be collected using a paper method
Time Frame
Baseline
Title
Macro nutrient intake
Description
3, 3-day diet journals will be collected using a paper method
Time Frame
week 4
Title
Macro nutrient intake
Description
3, 3-day diet journals will be collected using a paper method
Time Frame
week 8
Title
Micronutrient intake
Description
3, 3-day diet journals will be collected using a paper method
Time Frame
Baseline
Title
Micronutrient intake
Description
3, 3-day diet journals will be collected using a paper method
Time Frame
week 4
Title
Micronutrient intake
Description
3, 3-day diet journals will be collected using a paper method
Time Frame
week 8
Title
Dietary intake Satiety
Description
3, 3-day diet journals will be collected using a paper method
Time Frame
Baseline
Title
Dietary intake Satiety
Description
3, 3-day diet journals will be collected using a paper method
Time Frame
week 4
Title
Dietary intake Satiety
Description
3, 3-day diet journals will be collected using a paper method
Time Frame
week 8
Title
Dietary intake displacement
Description
3, 3-day diet journals will be collected using a paper method
Time Frame
Baseline
Title
Dietary intake displacement
Description
3, 3-day diet journals will be collected using a paper method
Time Frame
week 4
Title
Dietary intake displacement
Description
3, 3-day diet journals will be collected using a paper method
Time Frame
week 8
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonny Burns-Whitmore, DrPh, RD
Organizational Affiliation
California State Polytechnic University, Pomona
Official's Role
Study Director
Facility Information:
Facility Name
California State Polytechnic University, Pomona
City
Pomona
State/Province
California
ZIP/Postal Code
91766
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Chia on Overweight/Obese Women
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