Overweight
Conditions
Brief summary
The purpose of this project is to use white-skinned sweet potato as the main material for weight control for overweight and obesity, the non-communicable diseases (cardiovascular diseases, cancers, chronic respiratory diseases and diabetes) are also included. All high quality sweet potato are provided by CAES in Taiwan to produce special nutrient food and health food that to do functional study in Shih Chien University and Taipei Medical University. In this study, the investigators will recruit overweight and obesity subjects that divide into white sweet potato group (experimental group) and no intervention group (control group) by using randomized, parallel and open clinical study in sixty days.
Detailed description
All subjects will be evaluated the body weight and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination.
Interventions
DIETARY_SUPPLEMENTWhite sweet potato diet
The diet were supplied 516 kcal daily
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 24≦ BMI≦30
Exclusion criteria
* Pregnant and lactating women * Patients within six months after surgery * Mental illness or depression * Suffering from cancer, ulcers, acute respiratory infections, dialysis, acute hepatitis and other diseases * Those who have taken additional nutritional supplements habit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight After Intervention | 60 days | Body weight change after 60 days intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Fat After Intervention | 60 days | Body fat change after 60 days intervention |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Normal diet
White sweet potato meal replacement: The formula were supplied 516 kcal daily | 29 |
| Treatment Group Normal diet plus white sweet potato formula
White sweet potato meal replacement: The formula were supplied 516 kcal daily | 29 |
| Total | 58 |
Baseline characteristics
| Characteristic | Control Group | Treatment Group | Total |
|---|---|---|---|
| Age, Continuous | 37.33 years STANDARD_DEVIATION 5.51 | 38.76 years STANDARD_DEVIATION 6.24 | 38.07 years STANDARD_DEVIATION 5.89 |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
Body Weight After Intervention
Body weight change after 60 days intervention
Time frame: 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Body Weight After Intervention | -2.11 Kg | Standard Deviation 1.7 |
| Treatment Group | Body Weight After Intervention | -3.7 Kg | Standard Deviation 2.24 |
Secondary
Body Fat After Intervention
Body fat change after 60 days intervention
Time frame: 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Body Fat After Intervention | -0.95 percentage of body fat | Standard Deviation 2.21 |
| Treatment Group | Body Fat After Intervention | -2.26 percentage of body fat | Standard Deviation 2.09 |