The Effects of Chia on Overweight/Obese Women

Obesity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03233906
• Other study ID #: IRB-16-188
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 20, 2017
• Est. completion date: August 2018

Study information

• Verified date: May 2018
• Source: California State Polytechnic University, Pomona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Modification
• Eating Behavior
• Glucose
• Mood
• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United States	California State Polytechnic University, Pomona	Pomona	California

Sponsors (1)

Lead Sponsor	Collaborator
California State Polytechnic University, Pomona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting plasma glucose	12-hour fasting plasma glucose levels will be assessed using a glucometer	baseline
Primary	Waist Circumference	waist circumference will be measured for each participant	baseline
Primary	Caloric intake	9, 3-day diet journals will be collected using a paper method	baseline
Primary	Serotonin	Urine serotonin levels will be assessed	baseline
Primary	Body Weight	Tanita scale	Baseline
Primary	Body Mass Index	Tanita sclae	Baseline
Primary	Body Fat Percentage	Tanita scale	Baseline
Primary	Fasting plasma glucose	2-hour fasting plasma glucose levels will be assessed using a glucometer	week 4
Primary	Fasting plasma glucose	2-hour fasting plasma glucose levels will be assessed using a glucometer	week 8
Primary	Waist Circumference	waist circumference will be measured for each participant	week 4
Primary	Waist Circumference	waist will be measured for each participant	week 8
Primary	Caloric intake	9, 3-day diet journals will be collected using a paper method	week 4
Primary	Caloric intake	9, 3-day diet journals will be collected using a paper method	week 8
Primary	Serotonin	Urine serotonin levels will be assessed	week 4
Primary	Serotonin	Urine serotonin levels will be assessed	week 8
Primary	Body Weight	tanita scale	week 4
Primary	Body weight	tanita scale	week 8
Primary	Body mass index	tanita scale	week 4
Primary	body mass index	tanita scale	week 8
Primary	Body fat percentage	tanita scale	week 4
Primary	Body fat percentage	tanita scale	week 8
Primary	Hip Circumference	Hip Circumference will be measured for each participant	Baseline
Primary	Hip Circumference	Hip Circumference will be measured for each participant	week 4
Primary	Hip Circumference	Hip Circumference will be measured for each participant	week 8
Secondary	Blood Pressure	Blood pressure will be taken using an automatic blood pressure machine	baseline
Secondary	Blood Pressure	Blood pressure will be taken using an automatic blood pressure machine	week 4
Secondary	Blood Pressure	Blood pressure will be taken using an automatic blood pressure machine	week 8
Secondary	Joint Pain	Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis	baseline
Secondary	Joint Pain	Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis	week 4
Secondary	Joint Pain	Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis	week 8
Secondary	Mood	Major Depression Inventory	Baseline
Secondary	Mood	Major Depression Inventory	week 4
Secondary	Mood	Major Depression Inventory	week 8
Secondary	Physical Activity	INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT	Baseline
Secondary	Physical Activity	INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT	week 4
Secondary	Physical Activity	INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT	week 8
Secondary	Sleep Quality	Measuring sleep quality using the Pittsburgh Sleep Quality Index	Baseline
Secondary	Sleep Quality	Measuring sleep quality using the Pittsburgh Sleep Quality Index	week 4
Secondary	Sleep Quality	Measuring sleep quality using the Pittsburgh Sleep Quality Index	week 8
Secondary	Fat mass	using a tanita scale	Baseline
Secondary	Fat mass	using a tanita scale	week 4
Secondary	Fat mass	using a tanita scale	week 8
Secondary	Fat Free Mass	using a tanita scale	Baseline
Secondary	Fat Free Mass	using a tanita scale	week 4
Secondary	Fat Free Mass	using a tanita scale	week 8
Secondary	Total body water	using a tanita scale	Baseline
Secondary	Total body water	using a tanita scale	week 4
Secondary	Total body water	using a tanita scale	week 8
Secondary	Macro nutrient intake	3, 3-day diet journals will be collected using a paper method	Baseline
Secondary	Macro nutrient intake	3, 3-day diet journals will be collected using a paper method	week 4
Secondary	Macro nutrient intake	3, 3-day diet journals will be collected using a paper method	week 8
Secondary	Micronutrient intake	3, 3-day diet journals will be collected using a paper method	Baseline
Secondary	Micronutrient intake	3, 3-day diet journals will be collected using a paper method	week 4
Secondary	Micronutrient intake	3, 3-day diet journals will be collected using a paper method	week 8
Secondary	Dietary intake Satiety	3, 3-day diet journals will be collected using a paper method	Baseline
Secondary	Dietary intake Satiety	3, 3-day diet journals will be collected using a paper method	week 4
Secondary	Dietary intake Satiety	3, 3-day diet journals will be collected using a paper method	week 8
Secondary	Dietary intake displacement	3, 3-day diet journals will be collected using a paper method	Baseline
Secondary	Dietary intake displacement	3, 3-day diet journals will be collected using a paper method	week 4
Secondary	Dietary intake displacement	3, 3-day diet journals will be collected using a paper method	week 8