Efficacy and Safety of Attapulgite in Patients With Obesity: An Exploratory Clinical Trial

NCT07103382 | Recruiting

• 1 other identifier: 2025 Attapulgite
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the safety and efficacy of attapulgite in the treatment of obese individuals or overweight/obese individuals with type 2 diabetes.

Conditions

Obesity

Keywords

attapulgite; obesity; placebo-controlled study; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• BMI (Body Mass Index)

  BMI used to assess body weight relative to height, the unit of BMI is kg/m² (kilograms per square meter).

  "Baseline" "6 weeks" and "12 weeks"

Secondary Outcomes (30)

• Weight

  "Baseline" "6 weeks" and "12 weeks"

• Waist circumference

  "Baseline" "6 weeks" and "12 weeks"

• Hip circumference

  "Baseline" "6 weeks" and "12 weeks"

• Waist-to-hip ratio

  "Baseline" "6 weeks" and "12 weeks"

• Human body fat percentage

  "Baseline" and "12 weeks"

Study Arms (2)

Attapulgite

EXPERIMENTAL

Attapulgite capsules (0.4-0.5 g) were administered at a dose of 3 capsules twice daily for 12 weeks.

Dietary Supplement: Attapulgite

Placebo

PLACEBO COMPARATOR

Maltodextrin capsules (0.4-0.5 g) were administered at a dose of 3 capsules twice daily for 12 weeks.

Dietary Supplement: Placebo

Interventions

Attapulgite DIETARY_SUPPLEMENT

Participants were administered daily attapulgite (2.5 g) for a duration of 12 weeks.

Attapulgite

Placebo DIETARY_SUPPLEMENT

Participants were administered daily maltodextrin (2.5 g) for a duration of 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Obese individuals:
• Aged 18-60 years, regardless of sex/gender
• BMI≥28.0kg/m2
• Overweight or obese individuals with type 2 diabetes:
• Aged 18-60 years, regardless of sex/gender
• BMI≥24.0kg/m2
• HbA1c ≥7.0% and ≤10.0% or the fasting blood glucose ≥7.0 mmol/l and ≤ 13.3 mmol/l at screening
• Stable diabetes treatment for at least 6 months or more

You may not qualify if:

• Type 1 diabetes, monogenic diabetes, or diabetes due to pancreatic injury or other secondary diabetes
• Severe diabetic complications within three months before the study initiation, including severe hypoglycemia, diabetic ketoacidosis, or infections
• Use of weight-affecting products within the past three months or planned use during the study
• Weight fluctuation \>5 kg or \>10% within the past three months
• Obesity or overweight due to endocrine disorders (such as thyroid dysfunction or Cushing's syndrome)
• Uncontrolled hypertension, severe cardiac/hepatic/renal dysfunction
• History of gastrointestinal surgery (such as cholecystectomy) within the past year or non-gastrointestinal surgery within six months, or prior bariatric surgery
• Chronic gastrointestinal disorders (such as recurrent constipation, celiac disease, or food intolerances) or any condition impairing digestion/absorption function
• History of malignant tumors within five years, regardless of whether there is recurrence or metastasis and severe immune dysfunction (such as malignant tumors, HIV/AIDS, immunodeficiency diseases)
• Use of probiotics, prebiotics, or antibiotics within three months prior to enrollment, or alcohol abuse; Consumption of yogurt within two weeks before the study or during the trial period; History of psychiatric or infectious diseases
• Pregnancy, lactation, or plans for pregnancy during the study
• Participation in other clinical trials within the past three months
• Any condition that in the judgement of the investigator precludes participation

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

attapulgite

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Metabolism and Endocrinology, Institute of Metabolism and Endocrinology, National Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital, Central South University

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 5, 2025
• Study Start: June 26, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-06

Locations

CN (1)