Clinical trial NCT04156971: Effects of Omega-3 Supplementation on Nutritional Status and Physical Activity of Obese Children
Official title: Effects of Omega-3 Long-Chain Polyunsaturated Fatty Acids (N-3 LCPUFA) Supplementation on Body Composition, Biochemical Profile, Diet and Physical Activity of Obese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Life Style Modification
Childhood Obesity
Keywords: Childhood obesity
Life style modification
Omega 3
supplementation
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 37
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel study is a type of clinical study where two groups of treatments. The intervention group (IG) received stage-based lifestyle modification intervention and fish oil supplement, while the control group (CG) received stage-based lifestyle modification intervention only.
Primary purpose: TREATMENT

Brief summary: Omega-3 Long-Chain Polyunsaturated Fatty Acids has potential as a supplement that can accelerate the effects of a weight management program in children. This study assessed the effects of fish oil supplementation on biochemical profile, body composition, diet and physical activity of obese children. A total of 37 obese children (7-11 years) were randomized to intervention (n=19) or control (n=18) group. Data were collected at baseline, at follow-up (every four weeks) and at 24 of the interventions. The intervention group (IG) received stage-based lifestyle modification intervention and fish oil supplement, while the control group (CG) received stage-based lifestyle modification intervention only. Changes in biochemical profile, body composition, diet and physical activity were examined in both intervention and control groups.

Detailed description: Main objective To determine the effect of stage-based lifestyle modification and n-3 LCPUFA (DHA and EPA) supplements on body composition, biochemical profile, diet and physical activity of obese children.

Specific objectives

1. To compare changes in: i. Primary outcome: BMI-for-age ii. Secondary outcomes: Body composition (waist circumference \[WC\], mid-upper arm muscle circumference \[MUAMC\] and body fat percentage)

Biochemical profile:

Lipid profile (total cholesterol \[TC\], triglyceride \[TG\], low-density lipoprotein \[LDL\] and high-density lipoprotein \[HDL\]), fasting blood glucose (FBG), insulin and Homeostasis model assessment insulin-resistance index (HOMA-IR index), Fatty acid composition (DHA and EPA) Others: Adiponectin, high-sensitivity C-reactive protein (hs-CRP) and serum ferritin iii. Energy and nutrient intakes (Macronutrients, Saturated Fatty Acids \[SFA\], Polyunsaturated Fatty Acids \[PUFA\], Monounsaturated Fatty Acids \[MUFA\], Cholesterol and sugar and dietary fiber) vii. Physical activity between children receiving Stage-based Lifestyle Modification for the Management of Childhood Obesity with or without supplementation of 1320 mg of n-3 LCPUFA (DHA and EPA).

Intervention Group

Participants in the intervention group received Stage-based Lifestyle Modification and 16 weeks' supplementation of n-3 LCPUFA (DHA and EPA).

1. Stage-based Lifestyle Modification

   Stage-based Lifestyle Modification consists of several activities that include nutrition counselling, aerobic sessions, a hands-on activity 'Let's Play' and 'Sharing is Caring'. The recommendation for the dietary and physical activity modification was based on the NPG for the Management of Childhood Obesity (developed in Phase I). During the nutrition counselling session, educational topics related to dietary (reduce intake of fat and increase intake of fruits and vegetables) and physical activity modification (reduce sedentary activity and increase physical activity) were delivered based on the TTM.

   Participants' SOC for dietary and physical activity were determined before any information was given. This was important to ensure that the selected educational topic was tailored to the participant's current SOC. For each counselling session, at least two goals, one for dietary and one for physical activity, were set. Parents/caregivers were encouraged to participate in the nutrition counselling session. An aerobic session was conducted to encourage participants to be more active and increase their motivation levels, while a hands-on activity 'Let's Play' was aimed at increasing the knowledge of participants about food choices, food selection and healthy food preparation. The last activity was the 'Sharing is Caring' session to encourage parents/caregivers to share their experiences during the intervention period.
2. Supplementation of n-3 LCPUFA (DHA and EPA)

Participants in the intervention group were given fish oil capsules containing n-3 LCPUFA (DHA and EPA) for a duration of 16 weeks. The participants were required to consume two fish oil capsules, providing 1320 mg n-3 LCPUFA (792 mg EPA, 20:5n-3 and 528 mg DHA, 22:6n-3), and 6 IU vitamin E (D-alpha tocopherol) daily. The EPA and DHA ratio were, 1.5:1. The role of vitamin E is to stabilise the oil and is equal to 57%, 53.6% and 42.6% of Vitamin E RNI for Malaysia (2005) for children aged 7 to 9 years old, 10 to 12-year-old girls and 10 to 12-year-old boys, respectively. Participants were instructed to consume the capsules once a day before breakfast.

Determination of Dosage

Prior to supplementation with n-3 LCPUFA (DHA and EPA), other guidelines and outcomes of previous studies were reviewed. The recommendation of n-3 LCPUFA intake is 0.3 to 1.2% of total calorie intake. Supplementation of 0.6% of DHA/EPA from total energy is an acceptable range and an effective dosage for weight reduction in children and below the potential level that could lead to complications

The required dosage for the study ranged from 1186.7 mg to 1326.6 mg per day. Thus, the participants were asked to consume two fish oil capsules per day, which is equal to 1320 mg/day. Girls aged 7 to 9 years in the study consumed about 260 mg of DHA and EPA above their suggested amount. However, the amount is still below the potential level that could lead to complications. Each participant received sufficient fish oil capsules (60 capsules) for one month (30 days) of the intervention period.

Control Group Participants received Stage-based Lifestyle Modification for the management of childhood obesity only.

Study Measurements Information on demographic and socioeconomic, medical status, Child Feeding Questionnaire (CFQ), Family Eating and Activity Habits Questionnaire (FEAHQ) and Nutrition Knowledge at baseline were obtained though face-to-face interviews between researcher and parents/caregivers. With the help of their parents/caregivers, participants completed the Physical Activity Questionnaire for Older Children (PAQ-C) and three-day food record. Clear instructions were given to the parents/caregivers before they answered the questionnaires. In each visit, participants' anthropometric measurements were obtained and their BP was taken. Blood analysis was conducted at baseline, week 16 and week 24 for lipid profile, FBG, insulin and HOMA-IR index, fatty acid composition (DHA and EPA), adiponectin, hs-CRP and serum ferritin.

Eligibility criteria: Inclusion Criteria:

* Children aged 7 to 11 years old.
* Classified as obese (\>+2SD) based on BMI-for-age for 5 to 19 years old (WHO, 2007).

Exclusion Criteria:

• Children diagnosed with asthma, diabetes mellitus (DM), psychiatric disorders (e.g.

schizophrenia, severe autism or mental retardation, or psychosis), or other serious medical conditions.

* Children receiving medications that could potentially promote weight gain or weight loss.was sent to lab for lipid profile, FBG, insulin, hs-CRP and ferritin analysis.
* Children participating in any weight management programmes.
* Overweight, normal weight and underweight children.

Primary outcomes:
measure: BMI-for-age change
timeFrame: Change from Baseline SBMI-for-age at 24 weeks
Secondary outcomes:
measure: waist circumference [cm]
timeFrame: Every four weeks for a duration of 24 weeks
measure: Mid-Upper Arm Muscle Circumference [cm] Mid-Upper Arm Muscle Circumference
timeFrame: Every four weeks for a duration of 24 weeks
measure: Total cholesterol [TC] mmol/L
timeFrame: week 0, week 16 and week 24
measure: Triglyceride mmol/L
timeFrame: week 0, week 16 and week 24
measure: Low-density lipoprotein [LDL] mmol/L
timeFrame: week 0, week 16 and week 24
measure: High-density lipoprotein [HDL]) mmol/L
timeFrame: week 0, week 16 and week 24
measure: Fasting blood glucose (FBG) mmol/L
timeFrame: week 0, week 16 and week 24
measure: Insulin [uU/mL]
timeFrame: week 0, week 16 and week 24
measure: Homeostasis model assessment insulin-resistance index (HOMA-IR index)
timeFrame: week 0, week 16 and week 24
measure: DHA
timeFrame: week 0, week 16 and week 24
measure: EPA
timeFrame: week 0, week 16 and week 24
measure: Adiponectin
timeFrame: week 0, week 16 and week 24
measure: High-sensitivity C-reactive protein (hs-CRP)[mg/L]
timeFrame: week 0, week 16 and week 24
measure: Serum ferritin[ng/mL]
timeFrame: week 0, week 16 and week 24
measure: calorie
timeFrame: Every four weeks for a duration of 24 weeks
measure: Carbohydrate [g & %]
timeFrame: Every four weeks for a duration of 24 weeks
measure: Protein [g & %]
timeFrame: Every four weeks for a duration of 24 weeks
measure: Fat [g & %]
timeFrame: Every four weeks for a duration of 24 weeks
measure: Saturated fatty acid [g & %]
timeFrame: Every four weeks for a duration of 24 weeks
measure: Polyunsaturated fatty acid [g & %]
timeFrame: Every four weeks for a duration of 24 weeks
measure: monounsaturated fatty acid [g & %]
timeFrame: Every four weeks for a duration of 24 weeks
measure: Fibre [g & %]
timeFrame: Every four weeks for a duration of 24 weeks
measure: Sugar [g & %]
timeFrame: Every four weeks for a duration of 24 weeks
measure: Physical activity level
timeFrame: Every four weeks for a duration of 24 weeks
Other outcomes:
Locations:
Study officials:
References: