Clinical trial NCT03233906: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Eating Behavior
Mood
Glucose
Dietary Modification
Lead sponsor: California State Polytechnic University, Pomona
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Human subjects- females (18-45 y.o.) with a BMI greater than or equal to 26.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Fasting plasma glucose
timeFrame: baseline
measure: Waist Circumference
timeFrame: baseline
measure: Caloric intake
timeFrame: baseline
measure: Serotonin
timeFrame: baseline
measure: Body Weight
timeFrame: Baseline
measure: Body Mass Index
timeFrame: Baseline
measure: Body Fat Percentage
timeFrame: Baseline
measure: Fasting plasma glucose
timeFrame: week 4
measure: Fasting plasma glucose
timeFrame: week 8
measure: Waist Circumference
timeFrame: week 4
measure: Waist Circumference
timeFrame: week 8
measure: Caloric intake
timeFrame: week 4
measure: Caloric intake
timeFrame: week 8
measure: Serotonin
timeFrame: week 4
measure: Serotonin
timeFrame: week 8
measure: Body Weight
timeFrame: week 4
measure: Body weight
timeFrame: week 8
measure: Body mass index
timeFrame: week 4
measure: body mass index
timeFrame: week 8
measure: Body fat percentage
timeFrame: week 4
measure: Body fat percentage
timeFrame: week 8
measure: Hip Circumference
timeFrame: Baseline
measure: Hip Circumference
timeFrame: week 4
measure: Hip Circumference
timeFrame: week 8
Secondary outcomes:
measure: Blood Pressure
timeFrame: baseline
measure: Blood Pressure
timeFrame: week 4
measure: Blood Pressure
timeFrame: week 8
measure: Joint Pain
timeFrame: baseline
measure: Joint Pain
timeFrame: week 4
measure: Joint Pain
timeFrame: week 8
measure: Mood
timeFrame: Baseline
measure: Mood
timeFrame: week 4
measure: Mood
timeFrame: week 8
measure: Physical Activity
timeFrame: Baseline
measure: Physical Activity
timeFrame: week 4
measure: Physical Activity
timeFrame: week 8
measure: Sleep Quality
timeFrame: Baseline
measure: Sleep Quality
timeFrame: week 4
measure: Sleep Quality
timeFrame: week 8
measure: Fat mass
timeFrame: Baseline
measure: Fat mass
timeFrame: week 4
measure: Fat mass
timeFrame: week 8
measure: Fat Free Mass
timeFrame: Baseline
measure: Fat Free Mass
timeFrame: week 4
measure: Fat Free Mass
timeFrame: week 8
measure: Total body water
timeFrame: Baseline
measure: Total body water
timeFrame: week 4
measure: Total body water
timeFrame: week 8
measure: Macro nutrient intake
timeFrame: Baseline
measure: Macro nutrient intake
timeFrame: week 4
measure: Macro nutrient intake
timeFrame: week 8
measure: Micronutrient intake
timeFrame: Baseline
measure: Micronutrient intake
timeFrame: week 4
measure: Micronutrient intake
timeFrame: week 8
measure: Dietary intake Satiety
timeFrame: Baseline
measure: Dietary intake Satiety
timeFrame: week 4
measure: Dietary intake Satiety
timeFrame: week 8
measure: Dietary intake displacement
timeFrame: Baseline
measure: Dietary intake displacement
timeFrame: week 4
measure: Dietary intake displacement
timeFrame: week 8
Other outcomes:
Locations:
city: Pomona
country: United States
facility: California State Polytechnic University, Pomona
state: California
Study officials:
affiliation: California State Polytechnic University, Pomona
name: Bonny Burns-Whitmore, DrPh, RD
role: STUDY_DIRECTOR
References: