The Effects of Chia on Overweight/Obese Women
Keywords
Abstract
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).
Dates
| Last Verified: | 04/30/2018 |
| First Submitted: | 07/16/2017 |
| Estimated Enrollment Submitted: | 07/26/2017 |
| First Posted: | 07/30/2017 |
| Last Update Submitted: | 05/07/2018 |
| Last Update Posted: | 05/10/2018 |
| Actual Study Start Date: | 05/19/2017 |
| Estimated Primary Completion Date: | 04/30/2018 |
| Estimated Study Completion Date: | 07/31/2018 |
Condition or disease
Intervention/treatment
Dietary Supplement: Chia Seeds
Phase
Arm Groups
| 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 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. Fasting plasma glucose [baseline]
2. Waist Circumference [baseline]
3. Caloric intake [baseline]
4. Serotonin [baseline]
5. Body Weight [Baseline]
6. Body Mass Index [Baseline]
7. Body Fat Percentage [Baseline]
8. Fasting plasma glucose [week 4]
9. Fasting plasma glucose [week 8]
10. Waist Circumference [week 4]
11. Waist Circumference [week 8]
12. Caloric intake [week 4]
13. Caloric intake [week 8]
14. Serotonin [week 4]
15. Serotonin [week 8]
16. Body Weight [week 4]
17. Body weight [week 8]
18. Body mass index [week 4]
19. body mass index [week 8]
20. Body fat percentage [week 4]
21. Body fat percentage [week 8]
22. Hip Circumference [Baseline]
23. Hip Circumference [week 4]
24. Hip Circumference [week 8]
Secondary Outcome Measures
1. Blood Pressure [baseline]
2. Blood Pressure [week 4]
3. Blood Pressure [week 8]
4. Joint Pain [baseline]
5. Joint Pain [week 4]
6. Joint Pain [week 8]
7. Mood [Baseline]
8. Mood [week 4]
9. Mood [week 8]
10. Physical Activity [Baseline]
11. Physical Activity [week 4]
12. Physical Activity [week 8]
13. Sleep Quality [Baseline]
14. Sleep Quality [week 4]
15. Sleep Quality [week 8]
16. Fat mass [Baseline]
17. Fat mass [week 4]
18. Fat mass [week 8]
19. Fat Free Mass [Baseline]
20. Fat Free Mass [week 4]
21. Fat Free Mass [week 8]
22. Total body water [Baseline]
23. Total body water [week 4]
24. Total body water [week 8]
25. Macro nutrient intake [Baseline]
26. Macro nutrient intake [week 4]
27. Macro nutrient intake [week 8]
28. Micronutrient intake [Baseline]
29. Micronutrient intake [week 4]
30. Micronutrient intake [week 8]
31. Dietary intake Satiety [Baseline]
32. Dietary intake Satiety [week 4]
33. Dietary intake Satiety [week 8]
34. Dietary intake displacement [Baseline]
35. Dietary intake displacement [week 4]
36. Dietary intake displacement [week 8]
