The Effects of Chia on Overweight/Obese Women

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Mood; Dietary Modification; Eating Behavior; Glucose
• Intervention / Treatment: Dietary supplement: Chia Seeds- Salvia Hispanica

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
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pomona, California, United States, 91766
      • California State Polytechnic University, Pomona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting plasma glucose	12-hour fasting plasma glucose levels will be assessed using a glucometer	baseline
Waist Circumference	waist circumference will be measured for each participant	baseline
Caloric intake	9, 3-day diet journals will be collected using a paper method	baseline
Serotonin	Urine serotonin levels will be assessed	baseline
Body Weight	Tanita scale	Baseline
Body Mass Index	Tanita sclae	Baseline
Body Fat Percentage	Tanita scale	Baseline
Fasting plasma glucose	2-hour fasting plasma glucose levels will be assessed using a glucometer	week 4
Fasting plasma glucose	2-hour fasting plasma glucose levels will be assessed using a glucometer	week 8
Waist Circumference	waist circumference will be measured for each participant	week 4
Waist Circumference	waist will be measured for each participant	week 8
Caloric intake	9, 3-day diet journals will be collected using a paper method	week 4
Caloric intake	9, 3-day diet journals will be collected using a paper method	week 8
Serotonin	Urine serotonin levels will be assessed	week 4
Serotonin	Urine serotonin levels will be assessed	week 8
Body Weight	tanita scale	week 4
Body weight	tanita scale	week 8
Body mass index	tanita scale	week 4
body mass index	tanita scale	week 8
Body fat percentage	tanita scale	week 4
Body fat percentage	tanita scale	week 8
Hip Circumference	Hip Circumference will be measured for each participant	Baseline
Hip Circumference	Hip Circumference will be measured for each participant	week 4
Hip Circumference	Hip Circumference will be measured for each participant	week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Blood pressure will be taken using an automatic blood pressure machine	baseline
Blood Pressure	Blood pressure will be taken using an automatic blood pressure machine	week 4
Blood Pressure	Blood pressure will be taken using an automatic blood pressure machine	week 8
Joint Pain	Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis	baseline
Joint Pain	Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis	week 4
Joint Pain	Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis	week 8
Mood	Major Depression Inventory	Baseline
Mood	Major Depression Inventory	week 4
Mood	Major Depression Inventory	week 8
Physical Activity	INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT	Baseline
Physical Activity	INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT	week 4
Physical Activity	INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT	week 8
Sleep Quality	Measuring sleep quality using the Pittsburgh Sleep Quality Index	Baseline
Sleep Quality	Measuring sleep quality using the Pittsburgh Sleep Quality Index	week 4
Sleep Quality	Measuring sleep quality using the Pittsburgh Sleep Quality Index	week 8
Fat mass	using a tanita scale	Baseline
Fat mass	using a tanita scale	week 4
Fat mass	using a tanita scale	week 8
Fat Free Mass	using a tanita scale	Baseline
Fat Free Mass	using a tanita scale	week 4
Fat Free Mass	using a tanita scale	week 8
Total body water	using a tanita scale	Baseline
Total body water	using a tanita scale	week 4
Total body water	using a tanita scale	week 8
Macro nutrient intake	3, 3-day diet journals will be collected using a paper method	Baseline
Macro nutrient intake	3, 3-day diet journals will be collected using a paper method	week 4
Macro nutrient intake	3, 3-day diet journals will be collected using a paper method	week 8
Micronutrient intake	3, 3-day diet journals will be collected using a paper method	Baseline
Micronutrient intake	3, 3-day diet journals will be collected using a paper method	week 4
Micronutrient intake	3, 3-day diet journals will be collected using a paper method	week 8
Dietary intake Satiety	3, 3-day diet journals will be collected using a paper method	Baseline
Dietary intake Satiety	3, 3-day diet journals will be collected using a paper method	week 4
Dietary intake Satiety	3, 3-day diet journals will be collected using a paper method	week 8
Dietary intake displacement	3, 3-day diet journals will be collected using a paper method	Baseline
Dietary intake displacement	3, 3-day diet journals will be collected using a paper method	week 4
Dietary intake displacement	3, 3-day diet journals will be collected using a paper method	week 8

Collaborators and Investigators

• Sponsor: California State Polytechnic University, Pomona
• Investigators: Study Director: Bonny Burns-Whitmore, DrPh, RD, California State Polytechnic University, Pomona

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: IRB-16-188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No