---
title: Intermittent Fasting in Nonalcoholic Fatty Liver Disease
nct_id: NCT04355910
overall_status: UNKNOWN
phase: NA
sponsor: Shaoguan University
study_type: INTERVENTIONAL
primary_condition: Intermittent Fasting
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04355910.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04355910"
ct_last_update_post_date: 2020-04-21
last_seen_at: "2026-05-12T06:54:24.014Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Intermittent Fasting in Nonalcoholic Fatty Liver Disease

**Official Title:** Effects of Intermittent and Continuous Calorie Restriction on Body Weight and Metabolism in Adults With Nonalcoholic Fatty Liver Disease

**NCT ID:** [NCT04355910](https://clinicaltrials.gov/study/NCT04355910)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** Shaoguan University
- **Collaborators:** Guangdong Medical University, Sun Yat-sen University
- **Conditions:** Intermittent Fasting, Non-Alcoholic Fatty Liver Disease, Insulin Resistance, Obesity, Gut Microbiota
- **Start Date:** 2018-01-01
- **Completion Date:** 2020-08-31
- **CT.gov Last Update:** 2020-04-21

## Brief Summary

Although preliminary evidence suggests that intermittent fasting mimic-diet (IFD) exerts stronger effects on body weight and metabolic parameters, which may link obesity, non-alcoholic fatty liver disease (NAFLD) and major chronic diseases, compared with continuous calorie restriction (CCR), there is a lack of well-powered intervention studies. This randomized controlled trial will test whether IFD, operationalized as the "5:2 diet," has stronger effects on anthropometric and body composition characteristics, and circulating metabolic biomarkers than CCR and a control regimen in adults with NAFLD.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* The diagnosed criteria of fatty liver by ultrasound were presence of two of the three following criteria: increased hepatic echogenicity compared with cortical of the right kidney, blurring of liver vasculature, and deep attenuation of the ultrasonographic signal.

Exclusion Criteria:

* Excessive alcohol consumption (ethanol \> 140 g/wk for men and \> 70 g/wk for women), cirrhosis, viral hepatitis, cardiovascular disease, cancer, any consumption of nonsteroidal anti-inflammatory drugs, corticosteroids or prescriptive medicine that affect liver function, lipid and glucose metabolism.
```

## Arms

- **Intermittent fasting mimic-diet (IFD)** (EXPERIMENTAL) — Restrict 75% energy on two non-consecutive days each week.
- **Continuous calorie restriction (CCR)** (ACTIVE_COMPARATOR) — A daily 25% energy-restricted Mediterranean-type diet
- **Control** (NO_INTERVENTION) — No advice to restrict energy

## Interventions

- **Calorie restriction** (BEHAVIORAL) — Participants randomized to IFD were asked to restrict energy and carbohydrate on two non-consecutive days each week (75% energy restriction) and to consume a plant foods-based diet that met their estimated energy requirements for the remaining 5 d of the week.

The CCR group was prescribed a daily plant foods-based diet that was relatively low in fat with moderate energy-restriction (25% energy restriction).

The plant foods-based diet included adequate fruit and vegetable, nuts and seeds, whole-grain cereals, olive oil, fish and seafood, a moderate consumption of dairy products, poultry, eggs, and lean red meat.

## Primary Outcomes

- **Body weight** _(time frame: Change from baseline body weight at week 8)_ — Change of body weight

## Secondary Outcomes

- **Lipid profile** _(time frame: Change from baseline plasma TG, TC and LDL at week 8)_
- **Insulin resistance** _(time frame: Change from baseline plasma glucose and insulin at week 8)_
- **Gut microbiota** _(time frame: Change from baseline plasma bile acids and the gut microbiome at week 8)_

## Locations (1)

- Guangdong Medical University, Dongguan, Guangdong, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.guangdong medical university|dongguan|guangdong|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04355910*  
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