Modified Atkins Diet for Overweight and Obesity

NCT ID: NCT04207879

Last Updated: 2022-01-20

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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The mechanisms of obesity are complex, involved in genes, environment, life style, and systemic and adipose tissue inflammation. Dysbiosis of gut microbiome is considered to make a difference in obesity. On the other hand, both long-term and short-term dietary interventions can induce changes in the body composition and structure and function of gut microbiome. However, it is not really clear how gut microbiome changes along with weight loss in overweight or obese.

In the present study, investigators aim to characterize the gut microbiome among overweight or obese participants on a modified Atkins diets. The stool and blood samples were collected by an interval of every 5% and 10% of weight loss, respectively. Data collecting mainly covers: 1) body composition analysis ; 2) obesity related biochemical metabolism; 3) measurement of gut microbiome using metagenome and 16S rRNA sequencing techniques; 4) metabolomics of serum and gut microbiome; 5) measurement of physical activity and diets using questionnaires.

Conditions

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Overweight or Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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weight loss group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. 18-55 years old;
2. BMI \> 23.9kg/m2;
3. being willing and able to receive guidelines to a modified Atkins diet;
4. signed informed consent.

Exclusion Criteria

1. patients with serious physical and mental diseases (including cardiovascular and cerebrovascular diseases, liver and kidney diseases, respiratory diseases gastrointestinal diseases, mental diseases, etc.);
2. patients with malignant tumor;
3. pregnant and lactating women;
4. those with recent relocation plans.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Westlake University

OTHER

Sponsor Role collaborator

Hebei Medical University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dan Yu, PhD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hai-Ling Di, MD

Role: STUDY_DIRECTOR

Hebei Medical University Third Hospital

Locations

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Hebei Medical University Third Hospital

Shijiazhuang, Hebei, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 30935838 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31318902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29305401 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35635643 (View on PubMed)

Other Identifiers

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YD_20190301

Identifier Type: -

Identifier Source: org_study_id

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