The Effects of Chia on Overweight/Obese Women

NCT03233906 | Unknown

• 1 other identifier: IRB-16-188
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Eating Behavior; Mood; Glucose; Dietary Modification

Outcome Measures

Primary Outcomes (24)

• 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 Outcomes (36)

• Blood Pressure

  baseline

• Blood Pressure

  week 4

• Blood Pressure

  week 8

• Joint Pain

  baseline

• Joint Pain

  week 4

Study Arms (2)

Chia Seeds

ACTIVE COMPARATOR

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

Dietary Supplement: Chia Seeds- Salvia Hispanica

Control

NO INTERVENTION

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

Interventions

Chia Seeds- Salvia Hispanica 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.

Chia Seeds

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• California State Polytechnic University, Pomona: lead

Study Sites (1)

California State Polytechnic University, Pomona

Pomona, California, 91766, United States

Location

MeSH Terms

Conditions

Obesity; Feeding Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Bonny Burns-Whitmore, DrPh, RD

  California State Polytechnic University, Pomona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student, Human Nutrition and Food Science

Model Details: Human subjects- females (18-45 y.o.) with a BMI greater than or equal to 26.

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 31, 2017
• Study Start: May 20, 2017
• Primary Completion: May 1, 2018
• Study Completion: August 1, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)