Clinical trial NCT03343561: Effect of Dietary Intervention on Gut Microbiome in Hong Kong Obese Population
Official title: Effect of Dietary Intervention on Gut Microbiome in Hong Kong Obese Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Prenetics Limited
First posted: 2017-11-17
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Modern way of life characterized by decreased physical activity and poor dietary habits seems to be an important trigger for the onset of metabolic disorders. Accumulating evidence indicates that the gut microbiota is involved in host metabolism by increasing energy extraction, immune system modulation, and altering lipid metabolism, which play an intricate role in metabolic disorders, such as obesity and diabetes. Diet has a major role in shaping the composition and activity of gut microbiota. Consumptions of whole-grain and polyunsaturated fatty acids are known to exert certain extent of impacts on gut microbial communities in terms of participants' richness and diversity. In this study, the investigators aim to evaluate the impact of dietary intervention on gut microbiome in Hong Kong obese population

Detailed description: 1. Purpose of the Study Modern way of life characterized by decreased physical activity and poor dietary habits seems to be an important trigger for the onset of metabolic disorders. Accumulating evidence indicates that the gut microbiota is involved in host metabolism by increasing energy extraction, immune system modulation, and altering lipid metabolism, which play an intricate role in metabolic disorders, such as obesity and diabetes. Diet has a major role in shaping the composition and activity of gut microbiota. Consumptions of whole-grain and polyunsaturated fatty acids are known to exert certain extent of impacts on gut microbial communities in terms of the participants' richness and diversity. In this study, the investigators aim to evaluate the impact of dietary intervention on gut microbiome in Hong Kong obese population.
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.

Eligibility criteria: Inclusion Criteria:

* With BMI \>23kg/m2 Asian subjects, aged 30-60 years old

Exclusion Criteria:

* Chronic, clinically significant (unresolved, requiring on-going medical management or medication) pulmonary, cardiovascular (e.g. heart disease, high blood pressure etc.), gastrointestinal, hepatic or renal functional abnormality, and metabolic syndrome as determined by medical history or physical examination.
* 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.

Primary outcomes:
measure: Microbial Abundance Profile using QIIME 2.0
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Man-sau WONG, Doctoral
role: PRINCIPAL_INVESTIGATOR
References: