Effect of Dietary Intervention on Gut Microbiome in Hong Kong Obese Population
NCT ID: NCT03343561
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
48 participants
INTERVENTIONAL
2017-11-02
2018-12-31
Brief Summary
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Detailed Description
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2. Method of investigation
The study will last for 9 weeks. 48 eligible subjects aged 30-60 years old will be randomly allocated into 4 groups, to 3 of which nutrition advice on healthy diets and preferred food choices will be given while the remaining one will keep the participants' usual diets. Dietary surveys will be conducted to reveal the participants' dietary habits. Meanwhile, blood, stool and buccal swab will be collected to examine the effect of dietary intervention for example, changes of composition of gut microbiota, fasting blood glucose levels and lipid profiles as well as other metabolic indicators.
3. Approach
Subjects will be recruited via convenience sampling through internet and poster promotion. Screening for eligible subjects will be conducted by Research staff in PolyU on phone. If the participants are interested to join the study, the staff will explain study details and appointments will thus be made on a first come first serve basis. The study starts upon obtained consensus from subjects. Blood collection and testing will be outsourced to health check centre to further confirm the eligibility of subjects.
Eligible subjects will be randomly allocated into either control or intervention groups, in which subjects will receive dietitian consultations provided by registered dietitians. Also, stool, blood and buccal swab samples of subjects will be collected at various time points to examine changes of the investigators' desired parameters within the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control
Subjects would have subjects' own diet as usual
No interventions assigned to this group
Intervention diet 1
Nutrition advice will be given to subjects to consume a healthy diet and select food with Polyunsaturated fatty acids like fish and nuts to replace subjects' own food in high fat
Nutrition Advice
Intervention diet for 8 weeks for intervention group. Detailed 30 mins consultation in week 1 (provided by dietitian) and 15 min consultation (provided by RA) in week 4 to enhance subject adherence to the diet for intervention group. Control group subjects will receive 1 detailed 30 mins nutrition consultation from dietitian after the study.
Intervention diet 2
Nutrition advice will be given to subjects to consume a healthy diet and select food with whole grains to replace subjects own food in carbohydrate
Nutrition Advice
Intervention diet for 8 weeks for intervention group. Detailed 30 mins consultation in week 1 (provided by dietitian) and 15 min consultation (provided by RA) in week 4 to enhance subject adherence to the diet for intervention group. Control group subjects will receive 1 detailed 30 mins nutrition consultation from dietitian after the study.
Intervention diet 3
Nutrition advice will be given to subjects to consume a healthy diet and select food with healthy choices in fat and carbohydrate to replace subjects' own food choice
Nutrition Advice
Intervention diet for 8 weeks for intervention group. Detailed 30 mins consultation in week 1 (provided by dietitian) and 15 min consultation (provided by RA) in week 4 to enhance subject adherence to the diet for intervention group. Control group subjects will receive 1 detailed 30 mins nutrition consultation from dietitian after the study.
Interventions
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Nutrition Advice
Intervention diet for 8 weeks for intervention group. Detailed 30 mins consultation in week 1 (provided by dietitian) and 15 min consultation (provided by RA) in week 4 to enhance subject adherence to the diet for intervention group. Control group subjects will receive 1 detailed 30 mins nutrition consultation from dietitian after the study.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of active uncontrolled gastrointestinal disorders or diseases including: inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis; irritable bowel syndrome (IBW) (moderate-severe); persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated); chronic constipation
* Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
* Use of any of the following drugs within the 1 months sampling: systemic antibiotics, (intravenous, intramuscular, or oral); oral, intravenous, intramuscular, nasal or inhaled corticosteroids; cytokines; methotrexate or immunosuppressive cytotoxic agents; large doses of commercial probiotics consumed (greater than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
30 Years
60 Years
ALL
Yes
Sponsors
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Prenetics Limited
UNKNOWN
The Hong Kong Polytechnic University
OTHER
Responsible Party
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Prof. Man-sau WONG
Professor
Principal Investigators
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Man-sau WONG, Doctoral
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic University
Locations
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The Hong Kong Polytechnic University
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Yuk Fan NG, Mphil
Role: primary
Wing Si Vincy WONG, Degree
Role: backup
Related Links
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This study has registered in the system of clinical trial in HKU
Other Identifiers
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FSTRC2017PIS
Identifier Type: -
Identifier Source: org_study_id