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

Overview

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

Interventions

• Dietary supplement Attapulgite
  Participants were administered daily attapulgite (2.5 g) for a duration of 12 weeks.
• Dietary supplement Placebo
  Participants were administered daily maltodextrin (2.5 g) for a duration of 12 weeks.

Primary outcome measures

• BMI (Body Mass Index) [Time frame: "Baseline" "6 weeks" and "12 weeks"]

Secondary outcome measures (12)

• Weight [Time frame: "Baseline" "6 weeks" and "12 weeks"]
• Waist circumference [Time frame: "Baseline" "6 weeks" and "12 weeks"]
• Hip circumference [Time frame: "Baseline" "6 weeks" and "12 weeks"]
• Waist-to-hip ratio [Time frame: "Baseline" "6 weeks" and "12 weeks"]
• Human body fat percentage [Time frame: "Baseline" and "12 weeks"]
• Human basal metabolic rate [Time frame: "Baseline" and "12 weeks"]
• Visceral fat mass [Time frame: "Baseline" and "12 weeks"]
• Subcutaneous fat area [Time frame: "Baseline" and "12 weeks"]
• Serum triglycerides [Time frame: "Baseline" "6 weeks" and "12 weeks"]
• Serum total cholesterol [Time frame: "Baseline" "6 weeks" and "12 weeks"]
• Serum LDL-c [Time frame: "Baseline" "6 weeks" and "12 weeks"]
• Serum HDL-c [Time frame: "Baseline" "6 weeks" and "12 weeks"]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South Universi — Changsha

Identifiers

NCT: NCT07103382 · 2025 Attapulgite

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗