The Effects of Chia on Overweight/Obese Women

NCT ID: NCT03233906

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-20
• Study Completion Date: 2018-08-31

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).

Conditions

Obesity; Eating Behavior; Mood; Glucose; Dietary Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chia Seeds

10% of a participants total kcal estimated needs given in chia seeds everyday for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Chia Seeds- Salvia Hispanica

Intervention Type: DIETARY_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.

Control

Habitual diet with avoidance of high fiber and high omega-3 fatty acid foods.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

California State Polytechnic University, Pomona

OTHER

Sponsor Role: lead

Responsible Party

Desiree Vera

Graduate Student, Human Nutrition and Food Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bonny Burns-Whitmore, DrPh, RD

Role: STUDY_DIRECTOR

California State Polytechnic University, Pomona

Locations

California State Polytechnic University, Pomona

Pomona, California, United States

Countries

United States

Other Identifiers

IRB-16-188

Identifier Type: -

Identifier Source: org_study_id