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

NCT03343561 | Unknown

• 1 other identifier: FSTRC2017PIS
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Control

NO INTERVENTION

Subjects would have subjects' own diet as usual

Intervention diet 1

EXPERIMENTAL

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

Behavioral: Nutrition Advice

Intervention diet 2

EXPERIMENTAL

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

Behavioral: Nutrition Advice

Intervention diet 3

EXPERIMENTAL

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

Behavioral: Nutrition Advice

Interventions

Nutrition Advice BEHAVIORAL

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 1; Intervention diet 2; Intervention diet 3

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: M:F ratio is 1:1
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Prenetics Limited: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Related Links

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

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Man-sau WONG, Doctoral

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuk Fan NG, Mphil

CONTACT

85234008859; fanny.ng@polyu.edu.hk

Wing Si Vincy WONG, Bachelor

CONTACT

85234008783; wsvwong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As soon as the samples are obtained from the subjects, subjects will be coded straight-away. No samples will be stored with the subjects' name on, only codes will be used. Only the investigating team will be able to break the codes and trace the results back to the subjects. All the questionnaires will be only shown the subjects' code without subjects' name on them. No data file in hard or soft copy format will contain all the information on the subject's name, project code and experiment result.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 17, 2017
• Study Start: November 2, 2017
• Primary Completion: May 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)