Effect of Dietary Intervention on Gut Microbiome in Hong Kong Obese Population

Overweight Clinical Trial

Official title:

Effect of Dietary Intervention on Gut Microbiome in Hong Kong Obese Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03343561
• Other study ID #: FSTRC2017PIS
• Status: Recruiting
• Phase: N/A
• First received: November 1, 2017
• Last updated: November 10, 2017
• Start date: November 2, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2017
• Source: The Hong Kong Polytechnic University
• Contact: Yuk Fan NG, Mphil
• Phone: 85234008859
• Email: fanny.ng[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Prenetics Limited

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbial Abundance Profile using QIIME 2.0	Microbial Abundance Profile is a commonly used metric to assess the impact of interventions on microbial community (References: 1. The Human Microbiome Project Consortium. A framework for human microbiome research. Nature 486, 215-221 (2012). 2. Wu et al. Linking Long-Term Dietary Patterns with Gut Microbial Enterotypes. Science. 2011 Oct 7; 334(6052): 105-108;)	6 months

External Links

•   This study has registered in the system of clinical trial in HKU