Conjugated Linoleic Acid Combined With Nutrition Counseling Consequences on Body Weight and Body Fat Mass in Overweight and Obese Adult
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change of body weight
研究概览
简要总结
This study has purpose to assess the effect of conjugated linoleic acid (CLA)-fortified milk powder with nutrition counseling and nutrition module in body weight and body fat mass among overweight and obese adult in Indonesia
详细描述
After being informed of the potential benefits and risks regarding the study, the respondents were asked to sign the consent. The respondents who met the criteria of overweight/ obese without any historical diseases will be randomized into intervention or placebo groups. The intervention will be given for 12 weeks (CLA-fortified milk powder 3.4 gram, once-daily consumption). Both the intervention and placebo groups will also receive nutrition counseling and nutrition module.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) 23 - 24.9 kg/m2 for overweight and ≥ 25 kg/m2 for obese
- •Fat mass percentage (FM%) of ≥ 20% for men and ≥ 30% for women
- •Agree to follow the study
排除标准
- •Lactose intolerance
- •Undergoing treatment (e.g., antibiotics and/or anti-inflammatory or immunosuppressant drugs and weight loss)
- •Any physical condition that might be contraindicated to dietary restrictions
- •Any non-communicable disease (e.g., Diabetes Mellitus, Chronic Kidney Disease, Cancer, Hypertension)
研究组 & 干预措施
CLA-fortified milk powder
Respondents will receive CLA-fortified milk powder containing 3.4 gram for one a day for 12 weeks. They will also receive individualized nutrition counseling and nutrition module at weeks 0, 4, and 8.
干预措施: CLA-fortified milk powder (Dietary Supplement)
CLA-fortified milk powder
Respondents will receive CLA-fortified milk powder containing 3.4 gram for one a day for 12 weeks. They will also receive individualized nutrition counseling and nutrition module at weeks 0, 4, and 8.
干预措施: Nutrition Counseling (Other)
Placebo
Respondents will receive a placebo milk powder for one a day for 12 weeks. They will also receive individualized nutrition counseling and nutrition module at weeks 0, 4, and 8.
干预措施: Placebo (Other)
Placebo
Respondents will receive a placebo milk powder for one a day for 12 weeks. They will also receive individualized nutrition counseling and nutrition module at weeks 0, 4, and 8.
干预措施: Nutrition Counseling (Other)
结局指标
主要结局
Change of body weight
时间窗: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
to investigate the change of body weight before, during and after intervention. Using Seca® type 876 is calibrated scale to the nearest 0.1 kilogram. The lower body weight indicates better outcome
Change of body fat mass
时间窗: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
to investigate the change of body fat mass before, during, and after intervention. Using Bod Pod (Cosmed®). The lower body fat mass indicates better outcome
Change of body fat mass
时间窗: Baseline (after signing the consent) week-0 and week-12 (endline)
to investigate the change of body fat mass before and after intervention. Using Dual-energy X-ray absorptiometry (DXA GE Lunar® Prodigy 64179). The lower body fat mass indicates better outcome
次要结局
- Change of High Density Lipoprotein (HDL)(Baseline (after signing the consent) week-0 and week-12 (endline))
- Change of Waist hip ratio(Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline))
- Change of Low Density Lipoprotein (LDL)(Baseline (after signing the consent) week-0 and week-12 (endline))
- Change of Total of Cholesterol(Baseline (after signing the consent) week-0 and week-12 (endline))
- Change of Triglyceride(Baseline (after signing the consent) week-0 and week-12 (endline))
- Dietary intake (semi quantitative food frequency questionnaire)(Baseline (after signing the consent) week-0, week-8 and week-12 (endline))
- Dietary intake (24-hours recall)(Baseline (after signing the consent) week-0, week-8 and week-12 (endline))
- Physical activity level(Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline))
- Change of knowledge(Baseline (after signing the consent) week-0 and week-12 (endline))
- Change of attitude(Baseline (after signing the consent) week-0 and week-12 (endline))
研究者
Fiastuti Witjaksono
Principal Investigator
Indonesia University