Modified Atkins Diet for Overweight and Obesity

NCT04207879 | Unknown DMC

• 1 other identifier: YD_20190301
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate dynamic changes in biochemical metabolism, gut microbiome and its metabolites among overweight and obese participants while they are on a modified Atkins Diets.

Conditions

Overweight or Obesity

Keywords

modified Atkins Diet; Overweight; Obesity; Gut Microbiome; Body composition

Outcome Measures

Primary Outcomes (2)

• Dynamic changes of gut microbiome

  The stool sample will be collected by an interval of each 5% weight loss that participants experienced. Fecal microbiota will be analyzed by 16S rRNA gene sequencing technique.

  36 months

• Dynamic changes in faecal metabolomics

  For participants achieving each 10% weight loss, targeting metabonomics will be applied to identify the abundances of faecal metabolites (e.g. short-chain fatty acids, amino acids and carbohyrates) using validated mass spectrometry methods.

  36 months

Secondary Outcomes (7)

• Dynamic changes of body mass index

  36 months

• Dynamic changes of body fat

  36 months

• Dynamic changes of muscle mass

  36 months

• Dynamic changes of blood lipids

  36 months

• Dynamic changes of fasting blood glucose

  36 months

Study Arms (1)

weight loss group

Dynamic changes in body composition, biochemical metabolomics and gut microbiome will be reported among overweight and obese patients.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study is conducted in Shijiazhuang, a city in Northen China. Eligible participants are residents in this area and aged 18-55 years old, who are on a modified Atkins diet aiming to lose weight.

You may qualify if:

• years old;
• BMI \> 23.9kg/m2;
• being willing and able to receive guidelines to a modified Atkins diet;
• signed informed consent.

You may not qualify if:

• patients with serious physical and mental diseases (including cardiovascular and cerebrovascular diseases, liver and kidney diseases, respiratory diseases gastrointestinal diseases, mental diseases, etc.);
• patients with malignant tumor;
• pregnant and lactating women;
• those with recent relocation plans.

Sponsors & Collaborators

• Hebei Medical University Third Hospital: lead
• Westlake University: collaborator

Study Sites (1)

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, 050051, China

Location

Related Publications (4)

• Lin BY, Lin WD, Huang CK, Hsin MC, Lin WY, Pryor AD. Changes of gut microbiota between different weight reduction programs. Surg Obes Relat Dis. 2019 May;15(5):749-758. doi: 10.1016/j.soard.2019.01.026. Epub 2019 Jan 31.

  PMID: 30935838 BACKGROUND

• Frost F, Storck LJ, Kacprowski T, Gartner S, Ruhlemann M, Bang C, Franke A, Volker U, Aghdassi AA, Steveling A, Mayerle J, Weiss FU, Homuth G, Lerch MM. A structured weight loss program increases gut microbiota phylogenetic diversity and reduces levels of Collinsella in obese type 2 diabetics: A pilot study. PLoS One. 2019 Jul 18;14(7):e0219489. doi: 10.1371/journal.pone.0219489. eCollection 2019.

  PMID: 31318902 BACKGROUND

• Heianza Y, Sun D, Smith SR, Bray GA, Sacks FM, Qi L. Changes in Gut Microbiota-Related Metabolites and Long-term Successful Weight Loss in Response to Weight-Loss Diets: The POUNDS Lost Trial. Diabetes Care. 2018 Mar;41(3):413-419. doi: 10.2337/dc17-2108. Epub 2018 Jan 5.

  PMID: 29305401 BACKGROUND

• Yu D, Chen W, Zhang J, Wei L, Qin J, Lei M, Tang H, Wang Y, Xue S, Dong J, Chen Y, Xie L, Di H. Effects of weight loss on bone turnover, inflammatory cytokines, and adipokines in Chinese overweight and obese adults. J Endocrinol Invest. 2022 Sep;45(9):1757-1767. doi: 10.1007/s40618-022-01815-5. Epub 2022 May 30.

  PMID: 35635643 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, and feces

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Hai-Ling Di, MD

  Hebei Medical University Third Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 23, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2023
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 24 months after completion of the study
• Access Criteria: Qualified researchers engaged in rigorous, independent scientific research; Requests for access to the study data should be submitted via email to the principal investigator yudan20122013@163.com, and proposals are required to be attached for approval.

Locations

CN (1)